USFDA Takes New Regulatory Action Against Ranbaxy’s Paonta Sahib Plant in India

The U.S. Food and Drug Administration today announced that a facility owned by India-based Ranbaxy Laboratories falsified data and test results in approved and pending drug applications. The facility, Paonta Sahib, has been under an FDA Import Alert since September 2008.
The FDA is continuing to investigate this matter to ensure the safety and efficacy of marketed drugs associated with Ranbaxy’s Paonta Sahib site. To date, the FDA has no evidence that these drugs do not meet their quality specifications and has not identified any health risks associated with currently marketed Ranbaxy products.
In the meantime, the FDA recommends that patients not disrupt their drug therapy because this could jeopardize their health. Individuals who are concerned about their medications should talk with their health care professional.
The affected applications are for drugs that fall into three categories:
· Approved drugs made at the Paonta Sahib site for the U.S. market;
· Drugs pending approval at the FDA that are not yet marketed; and
· Certain drugs manufactured in the United States that relied on data from the Paonta Sahib facility.
“Companies must provide truthful and accurate information in their marketing applications,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The American public expects and deserves no less.”
To address the falsified data, the FDA has invoked its Application Integrity Policy (AIP) against the Paonta Sahib facility. The AIP is invoked when a company’s actions raise significant questions about the integrity of data in drug applications. This AIP covers applications that rely on data generated by the Paonta Sahib facility only.
Under the AIP, the FDA has asked Ranbaxy to cooperate with the agency to resolve the questions of data integrity and reliability. This would include implementing a Corrective Action Operating Plan (CAOP) to provide assurance of the integrity and reliability of data from the Paonta Sahib facility. A CAOP includes, but is not limited to, conducting a third-party independent audit of applications associated with Paonta Sahib.
When the AIP is implemented, the FDA stops all substantive scientific review of any new or pending drug approval applications that contain data generated by the Paonta Sahib facility.
“The FDA’s investigations revealed a pattern of questionable data raising significant questions regarding the reliability of certain applications, and this warrants applying the Application Integrity Policy,” said Deborah Autor, director of CDER’s Office of Compliance. “Today’s action reflects the FDA’s continued vigilance and its steadfast commitment to safeguarding the public’s health.”
On Sept. 16, 2008, the FDA issued two warning letters and instituted an Import Alert barring the entry of all finished drug products and active pharmaceutical ingredients from Ranbaxy’s Dewas, Paonta Sahib and Batamandi Unit facilities due to violations of U.S. current Good Manufacturing Practices requirements. That action barred the commercial importation of 30 different generic drugs into the United States and remains in effect.

Earlier news of IPPharmadoc on this issue Here, Here and Here
For drug safety information, read: FDA's Drug Safety Initiative
Read the FDA’s 2008 Warning Letters to Ranbaxy and the Import Alert
Read the redacted AIP letter to Ranbaxy
Read about the Application Integrity Policy
See a list of companies that have received an AIP

(Source: USFDA press release Here)

Raloxifene Hydrochloride (Evista) 60 mg Tablets: CAFC delayed Teva’s ANDA approval

Innovator Eli Lilly got a favorable decision from Court of Appeal for federal Circuit (CAFC) on Feb 24, 2008 w.r.t Raloxifene Hydrochloride 60 mg Tablets. CAFC has delayed Teva’s ANDA approval by 6 months. The Chief Judge Rader and Michel affirmed a district court order (by 2-1, with dissent from fellow Judge Prost)) extending the thirty-month stay of FDA approval of Teva's ANDA.

Teva filed its Para IV certification against Following Orange Book listed patents:
US5393763 (Expiry: Jul 28, 2012); which covers a method of inhibiting bone loss
US6906086 (Expiry: Jul 28, 2012); which covers a method of inhibiting post-menopausal bone loss in a post-menopausal woman in need of treatment to prevent or treat post-menopausal osteoporosis comprising administering a single daily oral dose to said woman of an effective amount of 6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl-4-[2-(piperidin-1-yl)ethox yphenyl]methanone hydrochloride.
USRE38968 (Expiry: Jul 28, 2012); which covers method of use in a post-menopausal woman in need of treatment to prevent or treat post-menopausal osteoporosis by use of Raloxifen
USRE39049 (Expiry: Jul 28, 2012); which covers method of use in a post-menopausal woman in need of treatment to prevent or treat post-menopausal osteoporosis by use of Raloxifen

USRE39050 (Expiry:Mar 2, 2014); which covers a method of inhibiting bone loss or resorption, or lowering serum cholesterol, comprising administering to a human in need thereof Raloxifen
US5478847 (Expiry:Mar 2, 2014); which covers a method of inhibiting bone loss or bone resorption comprising administering to a human in need thereof a Raloxifen, in an amount of about 50 to 150 mg/day.
US5457117 (Expiry: Jul 28, 2012); which covers a method of inhibiting bone loss comprising administering to a human in need thereof an effective amount of 6-hydroxy-2-(4-hydroxyphenyl)-benzo[B]thien-3-yl-4-[2-(piperidin-1-yl)etho xyphenyl]methanone hydrochloride.
US5393763 (Expiry: Jul 28, 2012); which covers a method of inhibiting bone loss or resorption, or lowering serum cholesterol, comprising administering to a human in need thereof Raloxifen

US5811120 (Expiry:Mar 2, 2014); which covers a solid administerable pharmaceutical formulation comprising raloxifene hydrochloride in combination with a surfactant, polyvinylpyrrolidone, and a water soluble diluent, wherein: the surfactant is a sorbitan fatty acid ester or a polyoxvethylene sorbitan fatty acid ester; and the water soluble diluent is a polyol or sugar.
US5972383 (Expiry:Mar 2, 2014); which covers a method of treating mammary tumors, prostatic tumors, or osteoporosis, comprising administering to a human in need thereof a solid orally administerable pharmaceutical formulation comprising raloxifene hydrochloride in combination with a surfactant, polyvinylpyrrolidone, and a water soluble diluent, wherein: the surfactant is a sorbitan fatty acid ester or a polyoxyethylene sorbitan fatty acid ester; and the water soluble diluent is a polyol or sugar.
US6894064 (Expiry:Mar 10, 2017); which covers a pharmaceutical composition comprising: a) 60 mg of 6-hydroxy-2-(4-hydroxy-phenyl)-3-[4-(2-piperidinoethoxy)benzoyl]benzo[b]th iophene hydrochloride, characterized in that the benzo[b]thiophene compound is in particulate form, said particles having a mean particle size of less than about 25 microns, at least about 90% of said particles have a size of less than about 50 microns; b) a surfactant; and c) a water-soluble diluent.
US6458811 (Expiry:Mar 10, 2017); which covers Raloxifen in particulate form, said particles having a mean particle size of less than about 25 microns, at least about 90% of said particles have a size of less than about 50 microns.
US6797719 (Expiry:Mar 10, 2017): which covers Raloxifen in particulate form, said particles having a mean particle size of less than about 25 microns, at least about 90% of said particles have a size of less than about 50 microns; b) a surfactant; and c) a water-soluble diluent.

Innovator sued Teva (within 45 days of Para IV notice from Teva) in Indiana Southern District Court in June, 2006 for infringement of method of use patents (Innovator not sued Teva on ‘064, '819 ,‘719 ), accordingly, Teva 's ANDA approval was delayed by 30 months. Additionally, innovator also sued Teva for following patents not listed in Orange Book:

US5747510 (Expiry:Mar 2, 2014); A pharmaceutical formulation in daily dosage unit form comprising, per daily dosage unit, an amount within the range of about 55 to about 150 mg of Raloxifen or a pharmaceutically acceptable salt or solvate thereof, said formulation in dosage unit form being adapted for oral administration in the form of a capsule or tablet.

US5641790 (Expiry:Jun 24, 2014); A pharmacuetical formulation in dosage unit form comprising per dosage unit, an amount within the range of about 55 to about 150 mg of a Raloxifen or a pharmaceutically acceptable salt or solvate thereof.

Innovator in it's amended complaint in 2007, asserted that Teva infringed patents covering particle size and formulation (‘064, '819 ,‘719 patents) of Raloxifen, after that Teva incorporated technical changes in its specification to design around against Orange Book patents on Particle size.
Innovator Eli Lilly, filed its Motion for Extension of Statutory Stay on September 17, 2008, pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), to extend the thirty-month statutory stay of the US FDA approval of Teva Pharma’s ANDA No. 78-193 for Raloxifene Hydrochloride 60 mg Tablets. The statutory stay was set to expire on November 16, 2008, and Teva has informed Lilly that it will launch its generic Raloxifene hydrochloride upon expiration of the statutory stay, if USFDA final approval is obtained by that date. Trial of this case was scheduled for March 9, 2009. Lilly requests a six-month extension of the thirty-month statutory stay based on Teva's failure to "reasonably cooperate in expediting the action," pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), as evidenced by Teva's last-minute change in its proposed drug product and its "multiple delays in producing critical discovery w.r.t particle size patents ‘064, 819 and ‘719 patents, which have adversely affected Lilly's infringement case and trial preparation." Lilly contends that, on July 10, 2008, it learned that, more than two years after filing ANDA No. 78-193, Teva altered its proposed drug product by changing:
(1) The particle size manufacturing specification of its Raloxifene hydrochloride API
(2) The method of measuring particle size (removing a five-second sonification step).
According to Lilly, these changes directly affect the underlying infringement action and, as a result of Teva's "eleventh hour" change to the proposed generic product and Teva's discovery tactics and delay in producing related documents and the altered Raloxifene samples, Lilly has been prejudiced in preparing for trial and developing its infringement case and the stay should be granted.Teva rejoins that the amendment it made to its Raloxifene ANDA, filed with the USFDA on July 8, 2008, is nothing more than a minor alteration of the product, and further, that it has reasonably cooperated in advancing this litigation by timely notifying Lilly on July 10, 2008, of the amendment and, within sixty days of filing the amendment, producing approximately 27,000 documents related to Teva's various Raloxifene lots and three industrial batch samples of the altered product that Lilly requested. Thus, Teva contends that an extension of the thirty-month stay would be inappropriate because Lilly is unable to demonstrate that Teva has failed to reasonably cooperate in advancing this litigation.

According to Teva, because ANDA amendments occur "with some frequency without regard for the status of the parallel patent litigation, absent some legislative history to the contrary, the thirty-month statutory stay should be viewed as already having accounted for the possibility of such amendments." Teva asserts that, rather than focusing on the substantive patent issues that this litigation is intended to address, Lilly is instead dedicating all of its efforts to raising regulatory issues that should be left to the USFDA.

Court in its decision concluded that the composition of the generic drug product for which USFDA approval is being sought and which innovator Lilly alleges to be the infringing product should be Verified. In light of the fact that Teva has recast its product more than eighteen months after it provided the original sample to Lilly and only eight months before trial is set to commence, we find that, in preparation for trial, Lilly is entitled to have a sufficient opportunity to identify the nature and composition of the Raloxifene product as Teva intends for it to be sold. A similar extension is warranted here in order to provide Lilly with a reasonable amount of time to allow its expert to test and report on the altered Raloxifene samples provided by Teva and for Lilly to assess and utilize that information and analysis in preparation for trial, which is set to commence on March 9, 2009. For the foregoing reasons, the Court hereby Extends until March 9, 2009, in this action the period under 21 U.S.C. § 355(j)(5)(B)(iii) during which the FDA is barred from approving ANDA No. 78-193.
Court Opinion Here

Oxymorphone hydrochloride (Opana ER): Endo and Penwest settled patent litigation with Actavis

Endo Pharmaceuticals, and Penwest Pharmaceuticals announced in a press release Here
that the companies have settled litigation with Actavis South Atlantic LLC regarding the production and sale of generic formulations of Opana ER (R)(oxymorphone hydrochloride) Extended Release Tablets CII. Endo and Penwest have agreed to dismiss their suit with prejudice and Actavis has agreed to dismiss its counterclaims with prejudice.
Under the terms of the settlement, Endo and Penwest have agreed to grant Actavis a license and a covenant not to sue to the patents in suit to sell a generic of Opana ER on or after July 15, 2011, and earlier under certain circumstances.

Earlier news of IPPharmdoc on this litigation Here

New Para IV filings till February 17, 2009

Clindamycin Phosphate (Evoclin) 1% Foam Para IV received prior to Feb 5, 2009
Daptomycin (Cubicin) For Injection 500 mg/vial Para IV filed on Nov 19, 2008
Erlotinib Hydrochloride (Tarceva) 25 mg, 100 mg and 150 mg tablets Para IV filed on Nov 18, 2008
Eszopiclone (Lunesta) 1 mg, 2 mg and 3 mg Tablets Para IV filed Dec15, 2008
Nisoldipine (Sular) Extended-release Tablets 25.5 mg and 34 mg Para IV filed on Nov 28, 2008

Paricalcitol (Zemplar) Injection 0.002 mg per mL in 1 mL vial and 0.005 mg per mL in 1 mL and 2 mL vials Para IV filed Nov 28, 2008

New Drug Approvals By USFDA

Final approvals

Uloric (Febuxostat) Tablets: Takeda Pharmaceuticals North America
TobraDex ST (Tobramycin and Dexamethasone) Ophthalmic Suspension: Alcon,
Nicotine Polacrilex Gum: IVAX Pharma
Meprobamate Tablets: Alembic
Lamotrigine Chewable Tablets: Glenmark Pharmaceuticals
Cetirizine Hydrochloride Tablets: Orchid Healthcare

Tentative approvals

Tenofovir Disoproxil Fumarate Tablets: Aurobindo Pharma
Tramadol Hydrochloride Extended-Release Capsules: Willcox & Savage

Galantamine Hydrobromide Extended-Release Capsules: IMPAX Laboratories

Montelukast (Singulair) tablets: Synthon announced European approvals for generic version

Synthon announced in a press release Here that it has successfully completed multiple decentralized procedures (DCP) for its newest product within its comprehensive portfolio: Montelukast. Regulatory clearance has been obtained for Synthon's product in sixteen European countries. Registration has been obtained for multiple dosage forms including a filmcoated tablet, intended for adults aged 15 years and above, and a chewable dosage form, intended for children aged 2 -14 years. Synthon' s product is a fully generic and bioequivalent version of the oral anti-asthma and anti-allergy agent Montelukast. Synthon will market Montelukast through its marketing partners in 4 and 5 mg chewable tablets and 10 mg filmcoated tablets.
Importantly , Montelukast is protected by Merck's following patent:

EP480717 (Expiry: Aug 25, 2012 with SPC in major European countries), which covers montelukast as product specifically.

Montelukast sodium is the active ingredient of Merck's branded product Singulair® , which is a leading oral anti-asthma and anti-allergy drug. Singulair® is indicated for the prophylaxis and chronic treatment of asthma, and for the relief of symptoms of seasonal allergic rhinitis (SAR). In Europe, sales of Montelukast were 605 million in 2008 with a 8 % annual growth (IMS Midas data).

Erlotinib (Tarceva®) 25, 100, 150 mg/Tablet: Innovator confirmed receipt of Para IV notice letter from Teva

Innovator OSI Pharma announced (in a press release Here) the receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals USA, Inc. submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Tarceva® (erlotinib) 25, 100, 150 mg/tablet. Following patents are listed in Orange Book for this product:
US5747498 (Expiry: Nov 8, 2018): Which covers Erlotinib as product
US6900221 (Expiry: Nov 9, 2020): Which covers a homogeneous crystalline polymorph of the hydrochloride salt of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-Quinazolinamine designated the B polymorph that exhibits an X-ray powder diffraction pattern having characteristic peaks expressed in degrees 2-theta at approximately 6.26, 12.48, 13.39, 16.96, 20.20, 21.10, 22.98, 24.46, 25.14, and 26.91.
US7087613 (Expiry: Nov 9, 2020): Which covers a method of monotherapy for a subject suffering from abnormal cell growth expressing the epiderinal growth factor receptor (EGFR) which comprises orally administering to the subject a therapeutically effective amount of a homogenous crystalline polymorph of the hydrochloride salt of N-(3-ethynylphenyl)-6,7-bis (2-methoxyethoxy)-4-quinazolinamine designated the B polymorph that exhibits an X-ray powder diffraction pattern having characteristic peaks expressed in degrees 2-theta at approximately 6.26, 12.48, 13.39, 16.96, 20.20, 21.10, 22.98, 24.46, 25.14, and 26.91 so as to treat the subject, wherein the abnormal cell growth is brain cancer, squamous cell cancer, bladder cancer, gastric cancer, pancreatic cancer, hepatic cancer, glioblastoma multiforme breast cancer, head cancer, neck cancer, esophageal cancer, prostate cancer, colorectal cancer, lung cancer, renal cancer, kidney cancer, ovarian cancer, gynecological cancer, thyroid cancer, non-small cell lung cancer (NSCLC), refractory ovarian cancer, or head and neck cancer.
OSI is currently reviewing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Teva and expects to file suit in that time frame. A lawsuit brought with respect to one or more of those patents would restrict the FDA from approving Teva's ANDA until May 18, 2012 (the statutory stay period), unless an adverse court ruling occurs prior to such time.

The earliest ANDA filing date for this product was November 18, 2008, accordingly, generic player filed their ANDA with Para IV certification to get 180 days exclusivity for this molecule. Earlier, innovator got approval to market Tarceva® (Erlotinib) 25, 100, 150 mg/tablet on Nov 18, 2004

Deptomycin (Cubicin) for Injection: Teva filed Para IV

Cubist Pharma announced that it has received a Paragraph IV Certification Notice Letter from Teva Parenteral Medicines notifying Cubist that TPM had submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) for approval to market a generic version of CUBICIN® (Daptomycin for injection). Teva's notice letter advised that it is seeking FDA approval to market daptomycin for injection prior to the expiration of US Patent Nos. 6,468,967 and 6,852,689, which expire on September 24, 2019, and US Patent No. RE39,071, which expires on June 15, 2016. The notice letter further stated that TPM is asserting that claims in the referenced patents are not infringed and/or invalid. Cubist also announced that it plans to file a patent infringement lawsuit against TPM in response to the ANDA filing. Cubist continues to be confident in its intellectual property portfolio protecting CUBICIN, including the patents listed in the FDA Orange Book.

(Source: Pharmalive)

Lanthanum carbonate (Fosrenol) Chewable tablets 500mg, 750mg and 1gm: Innovator Shire confirmed that Barr and Mylan filed Para IV

Innovator Shire, announced (in a press release here) that it has received Paragraph IV Notice letters from two generic players Barr Lab and Mylan dated February 2 and 4, 2009 respectively, advising in each case of the filing of an Abbreviated New Drug Application for a generic version of 500mg, 750mg and 1gm FOSRENOL(R), (Lanthanum carbonate) chewable tablets.
Innovator has following 3 Orange Book listed patents for Lanthanum carbonate (Fosrenol) Chewable tablets 500mg, 750mg and 1gm:
US5968976 (Expiry: Oct 26, 2018): Which coves a pharmaceutical composition for the treatment of hyperphosphataemia comprising lanthanum carbonate
US7381428 (Expiry: Aug 26, 2024): Which coves a stabilized Lanthanum Carbonate Compositions against substantial decarboxylation to lanthanum hydroxycarbonate before administration by admixing the lanthanum carbonate in an amount of from 13.4-13.9% to 32.2-33.3% by weight of the composition as elemental lanthanum with a monosaccharide or disaccharide in an amount from 20 to 80% by weight of the composition, wherein the monosaccharide or disaccharide is dextrates, mannitol, sorbitol, or a mixture thereof and the amount of the monosaccharide or disaccharide is such that lanthanum hydroxycarbonate is not observed in an x-ray powder diffraction (XRPD) pattern of the lanthanum carbonate composition after it has been exposed to 60 degree C and 95% relative humidity for at least 7 days.
US7465465 (Expiry: Aug 26, 2024): Which coves a lanthanum carbonate pharmaceutical formulation in a chewable tablet, comprising lanthanum carbonate in an amount of from about 200 mg to about 1000 mg elemental lanthanum in the proportion of about 10 to about 40 wt % of the formulation as elemental lanthanum and pharmaceutically acceptable excipients comprising a diluent in an amount from about 40 to about 80 wt % of the formulation and a flow agent in an amount from about 0.1 to about 5.0 wt % of the formulation, produced by a process which comprises the steps of: a. blending the lanthanum carbonate and the pharmaceutically acceptable excipients to form a mixture; or b. blending the lanthanum carbonate and the pharmaceutically acceptable excipients, compressing the resulting combination into a slug material or roller compacting the resulting combination into a strand material, and milling the prepared material into a free flowing mixture; and c. compressing the mixture formed in steps a or b into a tablet, wherein the process is performed without wet granulation or drying, the diluent is dextrates, corn syrup, oligosaccharide, isomaltooligosaccharide, glucose, lycasin, xylitol, lactitol, erythritol, mannitol, isomaltose, polydextrose, dextrin, starch, fructose, xylitol, maltodextrin, maltitol, isomalt, lactose, sorbitol, microcrystalline cellulose, sucrose based diluent-binders, confectioner's sugar, calcium sulfate dihydrate, calcium lactate trihydrate, hydrolysed starches, dextrose, inositol, hydrolyzed cereal solids, amylase, or glycine, and the flow agent is magnesium stearate, talc, polyethylene glycol, silica, colloidal anhydrous silica, hydrogenated vegetable oils, glyceryl behenate, or glyceryl monostearate.
innovator Shire believes these patents provide a robust and sustainable proprietary position for FOSRENOL under U.S. patent laws.
Shire is currently reviewing the detail of the Paragraph IV Notice letters from Barr and Mylan, and under the Hatch Waxman Act, has 45 days from the date of each notice letter to determine if it will file a patent infringement suit. If Shire brings suit pursuant to the Hatch Waxman regulations, a 30-month stay of approval will be imposed by the FDA on Barr's and Mylan's ANDA, which will commence on 26 October 2009.
Earlier, Innovator got approval for Lanthanum carbonate (Fosrenol) Chewable tablets 500mg on Oct 26, 2004, while, 750mg and 1gm were approved by USFDA on Nov 23, 2005

Minocycline HCI (Solodyn) ER tablets: Impax got final approval

IMPAX Lab confirmed (in a press release Here) that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for generic versions of SOLODYN(R) (Minocycline HCI) 45mg, 90mg and 135mg Extended-release Tablets. Medicis markets SOLODYN(R) for the treatment of moderate-to-severe acne.

Dr. Reddy's launched 5 generic formulations in US

Indian Pharma giant Dr. Reddy's Laboratories announced (In a press release here)
that it has launched the following five products in the US market during the month of January:
1. Levetiracetam tablets (250mg, 500mg, 750mg & 1000mg), the generic version of UCB Keppra® Tablets – with IMS annual sales of $1.1 billion.
2. Omeprazole capsules (40mg), the generic version of AstraZeneca's Prilosec® DR Capsules 40mg – with IMS annual sales of $168 mn.
3. Lamotragine CD chewable tablets (5mg & 25mg), the generic version of GlaxoSmithKline's Lamictal® CD Tablets – with IMS annual sales of $87 mn.
4. Divalproex capsules & delayed release pellets (125mg), the generic version of Abbott's

5. Depakote® Delayed Release Capsules 125mg – with IMS annual sales of $126 mn. Lamotrigine tablets (25mg, 100mg, 150mg & 200mg), the generic version of GlaxoSmithKline's Lamictal® Tablets – with IMS annual sales of $2.3 billion.

Paragraph IV certification reported by USFDA from November 2008 till February 3, 2009

Carbidopa+ Levodopa + Entacapone (Stalevo) Tablets 12.5 mg, 50 mg and 200 mg 50 on August 5, 2008 and 50mg/200mg/200mg on Aug 28, 2008

Duloxetine (Cymbalta) Delayed-release Capsules 20 mg, 30 mg and 60 mg on Aug 4, 2008

Emtricitabine and Tenofovir Disoproxil (Truvada) Tablets 200 mg/300 mg on September 26, 2008

Fluticasone (Cutivate) Lotion 0.05% on July 28, 2008

Pramipexole (Mirapex) Tablets 0.75 mg on July 31, 2008

Zoledronic acid (Reclast) Injection 0.05 mg/mL, 100 mL vial on Aug 29, 2008

Clobetasol ( Clobex) Spray 0.05% on Septemeber 29, 2008

Desflurane (Suprane) Inhalation 99.9% on September 11, 2008

Fenofibrate (Antara) Capsules 43 mg and 130 mg on September 15, 2008

Lovastatin and Niacin (Advicor) Extended-release Tablets 20 mg/500 mg on September 22, 2008

Olopatadine (Pataday) Ophthalmic Solution 0.2% on September 8, 2008

Tadalafil (Cialis) Tablets 2.5 mg on October 14, 2008

Testosterone (Testim) Gel 1% on October 21, 2008

Montelukast (Singular Granules) Oral Granules 4 mg on October 17, 2008

Paricalcitol (Zemplar) Capsules 1 mcg and 2 mcg on October 14, 2008

Risedronate (Actonel) Tablets 150 mg on October 8, 2008

Metformin Hydrochloride (Fortamet) 500 mg and 1000 mg Extended-release Tablets on October 14, 2008

Pemetrexed Disodium (Alimta)100 mg/vial For Injection on July 1, 2008

Metformin (Fortamet) Extended-release Tablets 500 and 1000mg on October 14, 2008

Pemetrexed (Alimta) For Injection 100 mg/vial on July 1, 2008

Aprepitant (Emend) Capsule 40 mg, 80 mg and 125 mg on November 3, 2008

Bortezomib (Velcade) For Injection 3.5 mg/vial on November 20, 2008

Conjugated Estrogen (Synthetic A) (Cenestin) Tablet 1.25 mg on November 3, 2008

Epinastine (Elestat) Ophthalmic Solution 0.05% on October 14, 2008

Eptifibatide (Integrilin) Injection 2 mg/mL, 10 mL vial on September 30, 2008

Lanthanum (Fosrenol) Chewable Tablet 500 mg, 750 mg and 1000 mg on October 27, 2008

lopinavir and Ritonavir (Kaletra) Tablets 100 mg/25 mg and 200 mg/50 mg on December 23, 2008

Metronidazole (Metrogel) Topical Gel 1% on October 21, 2008

Minocycline (Solodyn) Extended-release Tablet 45 mg, 90 mg and 135 mg, Para IV before Feb 5, 2009

Rropinirole (Requip XL) Extended-release Tablet 2 mg on October 14, 2008

Doxycycline Hyclate (Doryx) 75 mg and 100 mg before Feb 5, 2009

DOXYCYCLINE HYCLATE (DORYX) 75 and 100mg Delayed Release Tablets: Innovator Warner Chilcott Sued another generic player

Innovator Warner Chilcott Limited announced today that its subsidiaries Mayne Pharma have filed a lawsuit against generic company Actavis Elizabeth in the District Court for the District of New Jersey for infringement of Mayne's following Orange Book listed patent for DOXYCYCLINE HYCLATE (DORYX) 75 and 100mg Delayed Release Tablets:
US6958161 (Expiry: Dec 15, 2022): Which covers a modified release preparation having one or more coated core elements, each core element comprising an active ingredient selected from the group consisting of the acid salts of Doxycycline, Tetracycline, Oxytetracycline, Minocycline, Chlortetracycline or Demeclocycline and having a modified release coating, wherein a stabilising coat is provided between each core element and its modified release coating so that, upon in vitro dissolution testing, the amount of active ingredient released at any time on a post-storage dissolution profile is within 40 percentage points of the amount of active ingredient released at any time on a pre-storage dissolution profile..
Earlier, innovator has sued Impax, Mutual Pharma, Mylan Pharma and Sandoz for the infringement of ‘161 patent in District of New Jersey as reported earlier by this blog Here

AndroGel (1% testosterone gel): FTC Filed Complaint Against Par Pharma and Watson Over Georgia District Court Approved Settlement

The US Federal Trade Commission has filed suit in US Federal court in an attempt to block a deal in which an innovator of testosterone-replacement drug paid the generic competitors (Par, Paddock and Watson) to delay generic entry. The FTC said that "Pay-for-Delay" agreement are not in public interest.

Par Pharmaceutical announced (in a press release Here) that the Federal Trade Commission (FTC) and the California Attorney General filed a lawsuit against Par in the U.S. District Court for the District of Central California. The FTC lawsuit makes antitrust and other allegations about a patent settlement agreement that was approved by the U.S. District Court for the Northern District of Georgia in 2006. The 2006 court-approved settlement ended litigation between Par Pharmaceutical, Paddock Laboratories and plaintiff Solvay Pharmaceuticals over Paddock and Par’s filing of an Abbreviated New Drug Application for a generic version of Solvay’s AndroGel® 1% testosterone gel product.
Under the terms of the 2006 court-approved settlement, Par is permitted to begin marketing testosterone gel 1% in August 2015 — five years prior to the expiration of the AndroGel® following patent:
US6503894 (Expiry: Mar 1, 2021 with PED): Which covers a pharmaceutical composition, consisting essentially of: a. about 0.5% to about 10% testosterone; b. about 30% to about 98% alcohol selected from the group consisting of ethanol and isopropanol; c. about 0.1% to about 5% isopropyl myristate; d. about 1% to about 5% sodium hydroxide; and e. about 0.1% to about 5% of a gelling agent, wherein the percentages of components are weight to weight of the composition.
Par was the second ANDA filer for testosterone gel 1% and therefore not eligible for 180 days of marketing exclusivity. However, the 2006 settlement allowed Par’s early entry date to be the same as that obtained by the first ANDA filer. Par issued a press release on September 13, 2006 addressing further details of the 2006 court-approved settlement and contemporaneous business agreements.
Another generic player Watson (first para IV filer) have announced ( in a press release Here)
that the U.S. Federal Trade Commission (FTC) and the State of California have filed a lawsuit in the United States District Court for the Central District of California alleging that the Company's 2006 patent lawsuit settlement with Solvay Pharmaceuticals Inc. related to AndroGel(R) 1% (testosterone gel) CIII is unlawful.
Earlier in 2003, Watson submitted an Abbreviated New Drug Application (ANDA) with para IV certification against ‘893 patent, seeking approval to market a generic version of AndroGel. Solvay initiated litigation against Watson alleging that its product infringed Solvay's patent. Under terms of a 2006 settlement agreement, Solvay granted Watson a non-exclusive license to the U.S. patents covering AndroGel. Watson agreed not to commence marketing its generic equivalent product until August 31, 2015 or the date on which another generic product enters the U.S. market, whichever occurs first. Additionally, Watson agreed to forfeit its 180-day marketing exclusivity on the product awarded under the Hatch-Waxman Act.