Lamotrigin (25, 100, 150 and 200 mg/tablet): Generic formulations entered US matrket

The generic players have entered into the US market after the expiry of innovator GSK’ patent US4602017 (Expiry: Jan 22, 2009): which covers Lamotrigin as product.
Following generic players have got tentative or final approval for this product:

1. Cadista- Approved on January 27, 2009 for ANDA No. 079132

2. Teva- Approval on August 30, 2006 for ANDA No. 076388

3. Dr. Reddy- Approval on January 27, 2009 for ANDA No. 076708

4. Roxane- Approved on January 27, 2009 for ANDA No. 077392

5. Mylan- Approved on January 27, 2009 for ANDA No. 077420

6. Genpharm- Approved on June 21, 2006 for ANDA No. 077428

7. Zydus Pharm- Approved on January 27, 2009 for ANDA No. 077633

8. Caraco- Approved on November 9, 2007 for ANDA No. 077757

9. Watson- Approved on November 9, 2007 for ANDA No. 077783

10. Matrix- Approved on November 9, 2007 for ANDA No. 078443

11. Taro- Approved on January 27, 2009 for ANDA No. 078525

12. Apotex- Approved on January 27, 2009 for ANDA No. 078625

13. Sandoz- Approved on January 27, 2009 for ANDA No. 078645

14. Torrent- Approved on January 27, 2009 for ANDA No. 078947

15. Aurbindo- Approved on January 27, 2009 for ANDA No. 078956

Note: Caraco, Watson and Matrix has got tentative approval

Lamotrigin is indicated for treatment of convulsions. Lamotrigine was first approved by the USFDA in 1994, for the treatment of partial seizures, and in 2003 for long-term management of bipolar disorder

Innovator to Innovator takeover: Pfizer to Buy Wyeth

In one of the major takeover of this year, a innovator company (Pfizer) will takeover another innovator company (Wyeth). Last year a trend was seen where either generic compnay acquired generic company (like Teva acquired Barr) or innovator company acquired generic company (like Daiichi acquired Ranbaxy) as reported earlier by IPPharmdoc on pharma takeover Here.

Innovator company Pfizer had announcement on January 26 that it will buy Wyeth for $68 billion in cash and stock called up visions of past Pfizer acquisitions for many pharmaceutical executives—and some of those visions resembled nightmares. But Pfizer CEO Jeffrey Kindler, who took the top job in 2006, insists the Wyeth deal is different from its earlier mega-mergers with Warner-Lambert in 2000 and Pharmacia in 2003.
Link to full news Here

Epinastine Hydrochloride (Elestat) 0.05% Ophthalmic Solution/drops: 3 generic companies filed ANDA

Three generic drug-makers have filed regulatory applications (as reported by newsobserver here) to make cheaper versions of Elestat, an allergy medicine made by Allergan and sold by Inspire Pharmaceuticals of Durham.
The Generic players have filed ANDA with Para IV certification against following Orange Book listed patent:
US7429602 (Issued on: September 30, 2008, Expiry: Nov 29, 2020): A method for treating allergic conjunctivitis, comprising topically administering to the conjunctiva of a host in need of such treatment a solution comprising: (a) a pharmaceutically active ingredient consisting essentially of Epinastine, optionally in the form of its racemate, or an enantiomer thereof, or a pharmacologically acceptable acid addition salt thereof, in a concentration of 0.005 to 0.5 mg/ml of solution; (b) water or physiologically acceptable saline; and (c) a preservative, optionally also including one or more chelating agents, viscosity agents, penetration promoters, antioxidants, substances to adjust the tonicity of the solution, or a physiologically acceptable buffer. Innovator

Allergen got approval to market this product on Oct 16, 2003. Further, there are chances that innovator sue the companies who have filed Para IV against said patent to block the ANDA approval for 30 months.

Metaxalone (Skelaxin): New York court invalidated two important patents of innovator

King Pharma announced that the U.S. District Court for the Eastern District of New York in the case of King Pharma v. Eon Labs, Case No. 04-cv-5540 (DGT), issued a summary Judgement opinion by invalidating two important patents relating to SKELAXIN® (Metaxalone).
Following patents are listed in Orange Book for this product:
US6407128 (Expiry: Dec 3, 2021): Which covers a method of increasing the oral bioavailability of metaxalone to a patient receiving metaxalone therapy comprising administering to the patient a therapeutically effective amount of metaxalone in a pharmaceutical composition with food.
US6683102 (Expiry: Dec 3, 2021) : A method of using metaxalone in the treatment of musculoskeletal conditions comprising: providing the patient with a therapeutically effective amount of metaxalone; and informing the patient that the administration of metaxalone with food results in an increase in at least one of C(max) and AUC(last) of metaxalone compared to administration without food.
US7122566 (Expiry: Feb 6, 2026): A method of using metaxalone for treating a patient's condition, comprising providing a patient with metaxalone; and informing the patient or a medical care worker that metaxalone affects activity of a cytochrome p450 isozyme, and that administration of metaxalone with a substance that affects activity of a cytochrome p450 isozyme can affect plasma concentration, safety, efficacy or any combination thereof of metaxalone, the substance, or both.

Eon filed ANDA with Para IV in 2003 for this product. Subsequently, innovator sued Eon for the infringement of ‘128 and ‘102 patents in New York Eastern District Court.
As per court’s summary judgment opinion, the ‘128 and ‘102 patents, which basically cover improved bioavailability of Mataxolone with food were held invalid and obvious in the light of following prior art disclosure:
1) Fathie et al (Article I) published in Current therapeutic research (1964),
2) Fathie et al (Article II) published in Clinical Medicine (1965)
3) Morey et al published in Journal of Osteopathic Association (1963)
4) Albanese et al published in Nurses Drug References (1982)
5) Abrams et al published in Clinical Drug Therapy (1995)
6) Dent et al published in Current Therapeutic Research (1975)
The above prior art disclosure discuss use of Metaxalone 400 mg and 800 g tablets with food.
The Company plans to appeal the Order, which was issued in response to Eon’s motion for summary judgment without the benefit of a hearing.

Furthermore, the Order is unrelated to the Company’s pending litigation against Sandoz, Inc., successor to Eon, in the U.S. District Court for the District of New Jersey regarding’566 patent. Importantly, Sandoz does not currently have an Abbreviated New Drug Application approved by the U.S. Food and Drug Administration to market a generic version of SKELAXIN®.

Innovator got approval for its NDA on 800mg tablets on Aug 30, 2002

Innovator is already in litigation with Mutual Pharmaceutical and Sandoz. However, innovator has settled its litigation with Core pharma in January, 2008 as reported earlier by this blog Here

Esomeprazole Magnesium (Nexium): Innovator AstraZeneca sued Sandoz

Innovator AstraZeneca has sued another generic player over Esomeprazole Magnesium ER 20 and 40 mg capsules patents. Innovator has filed an infringement suit against Sandoz in New Jersey District Court for to protect its monopoly over the blockbuster medication after Sandoz filed ANDA with Para IV certification against Orange Book listed patents for Esomeprazole magnesium capsules.
Innovator has alleged Infringement of following patents in the complaint:
US5714504 (Expiry: Aug 3, 2015): which covers a pharmaceutical formulation for oral administration comprising a pure solid state alkaline salt of the (-)-enantiomer of 5-methoxy-2[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzi midazole and a pharmaceutically acceptable carrier.
US5877192 (Expiry: Nov 27, 2014) : which covers a method for treatment of gastric acid related diseases by inhibition of gastric acid secretion comprising administering to a mammal in need of treatment a therapeutically effective amount of a proton pump inhibitor consisting essentially of the (-)-enantiomer of 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benz imidazole or a pharmaceutically acceptable salt thereof, so as to effect decreased interindividual variation in plasma levels (AUC) during treatment of gastric acid related diseases.
US6875872 (Expiry: Nov 27, 2014): which covers a Magnesium salt of (-)-5-methoxy-2-[[(4-methoxy-3,5,dimethyl-2-pyridinyl)methyl]sulfinyl]-1H- benzimidazole in an optical purity of at least about 94% enantiomeric excess.
US6369085 (Expiry: Nov 25, 2018): which covers a the magnesium salt of S-omeprazole trihydrate, with XRD and process of manugacturing the same
US7411070 (Expiry: Nov 25, 2018): which covers a the magnesium salt of S-omeprazole trihydrate.
Innovator is already in litigation with IVAX Corporation, Zenith, Teva and Dr. Reddy's for this product in New Jersey court. Earlier in April 2008, Innovator announced patent settlement with first Para IV filer Ranbaxy. As per settlement agreement, Ranbaxy will commence sales of a generic version of Nexium under a licence from AstraZeneca on May 27, 2014 onwards.

Desloratadine (Clarinex): GeoPharma also settled patent litigation with innovator

Generic player Geopharm announced (in a press release Here) that it would be able to commercially launch a generic version of the anti-allergy drug Desloratadine (Clarinex) in United States after settling pending patent litigation. Geopharm is 6th generic player, who has settled the pending patent litigation on Clarinex.
Specific financial terms and conditions of the settlement agreement were not disclosed, but it allows GeoPharma to receive a license under all relevant patents, the release said.
GeoPharma will launch its generic Desloratadine version, with six months marketing co-exclusivity, on July 1, 2012, or earlier in certain circumstances. The new product launch can be a prescription or Over-The-Counter (OTC) product, depending on its status at the time of launch. Earlier, innovator Schering sued Geopharm for patent infringement of following patents based upon its filing of an ANDA containing a Paragraph IV certification:

US6100274: Which covers Stable formulation

US7214683: Which covers formulation of Descarboethoxyloratadine

US7214684: Method of use of descarboethoxyloratadine

Earlier, innovator had sued various generic players like Zydus, Sandoz, Mylan, Orchid, Perrigo, Glenmark, GeoPharma, Lupin, Ranbaxy, Sun, Watson, Dr. Reddy's who filed ANDA to market this product. Importantly, Innovator has patents listed in orange Book with expiries in 2020.
Apart from Geopharm, innovator had settled with Perrigo, Watson Pharma and Ranbaxy,

Dr. Reddy, Lupin. Possibly, all generic players are in licensing agreement with Innovator and would launch generic around July, 2012.

Earlier news of IP Pharma Doc on Desloratadine Here

Sirolimus-Eluting Stent System: Court declared Boston Scientific patent invalid

Boston Scientific Corporation today announced a decision by the Court of Appeals for the Federal Circuit. The case involves a Boston Scientific following patent, which in part is directed to drug-eluting stents and coating systems:
US6120536 (Assignee: Schneider): which covers a medical device having at least a portion which is implantable into the body of a patient, wherein at least a part of the device portion is metallic and at least part of the metallic device portion is covered with a coating for release of at least one biologically active material, wherein said coating comprises an undercoat comprising a hydrophobic elastomeric material incorporating an amount of biologically active material therein for timed release therefrom, and wherein said coating further comprises a topcoat which at least partially covers the undercoat, said topcoat comprising a biostable, non-thrombogenic material which provides long term non-thromobogenicity to the device portion during and after release of the biologically active material, and wherein said topcoat is substantially free of an elutable material.
In the decision, the Court found that the patent was invalid as obvious over the prior art. The case was an appeal by Johnson and Johnson of a 2005 jury verdict in the United States District Court for the District of Delaware that found the patent was valid and infringed by Johnson and Johnson's Cypher(R) Sirolimus-Eluting Stent System.

Link to court opinion Here

Warner Chilcott, Watson settle oral contraceptive products patent litigation

Watson Pharmaceuticals, Inc. and Warner Chilcott Limited announced that they have entered into settlement and license agreements to resolve pending patent litigation related to Warner Chilcott's oral contraceptive products, Loestrin 24 and Femcon Fe.
Under the terms of the settlement agreements, Warner Chilcott has granted Watson a non-exclusive license to the US patents covering Loestrin 24 Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets) and Femcon Fe (norethindrone, ethinyl estradiol tablets, chewable, ferrous fumarate tablets). The agreement covering Loestrin 24 Fe will permit Watson to commence marketing its generic equivalent product on the earlier of January 22, 2014 or the date on which another generic version of Loestrin 24 Fe enters the US market. The agreement covering Femcon Fe will permit Watson to commence marketing its generic equivalent product on the earlier of 180 days after Barr Laboratories, Inc. (now Teva Pharmaceutical Industries, Ltd.) enters the market with a generic equivalent product, or January 1, 2013.

Link to pharmabiz article Here

Levitiracetam: Aurobindo, Orchid, Lupin and Glenmark got USFDA nod

Four Indian pharma majors, Aurobindo Pharma, Orchid Chemicals and Pharmaceuticals, Lupin Ltd and Glenmark Pharmaceuticals have received the US FDA approval for Abbreviated New Drug Application (ANDA) for marketing and distribution of Levetiracetam tablets of 250 mg, 500 mg and 750 mg range in the US market.

Link to full article Here

Antara (Fenofibrate): Innovator sued Lupin

Oscient Pharmaceuticals Corp. and a handful of affiliates have filed a patent-infringement suit in Maryland district court against Lupin Pharmaceuticals and its parent company Lupin Limited, based in India.
At issue is an Abbreviated New Drug Application, filed by Baltimore-based Lupin that Oscient claims infringes on its cholesterol-fighting drug Antara.

Details are Here

Minocycline Hydrochloride (Solodyn): Innovator Medicis Sues Mylan, Sandoz to Stop Generic version

Medicis Pharmaceutical Corp had sued Mylan, Teva Pharma, Barr Laboratories and other companies to block generic versions of Medicis’s Minocycline Hydrochloride (Solodyn) acne drug.
Medicis said the generic version of the drug would violate a patent and also named Sandoz AG and Mylan’s Matrix Laboratories unit in a complaint filed yesterday in federal court in Delaware. Medicis, based in Scottsdale, Arizona, is seeking an order stopping the rival drugmakers from producing and marketing the treatment and unspecified damages.

Full article Here

Terazosin Hydrochloride (Hytrin): US court of appeal for 9th Circuit revived antitrust case

The U.S. Court of Appeals for the Ninth Circuit has revived the long-standing antitrust case over the Terazosin Hydrochloride (Hytrin) settlement, remanding a portion of the suit for further proceedings after a decade of litigation over the hypertension drug.
Plantiff-appellent Kaiser Foundation sued innovator Abbot and generic player Geneva for violation of the Sherman antitrust act and analogus provision of California law. Plaintiff Kaiser brought a claim under section one (Restraint of trade claim) of the Sherman Act against both Abbot and Geneva, and a claim under section two (monopolization) against Abbot. A multidistrict litigation Federal district court in Florida allowed Kaiser’s Section one claim to go to trial. The suit transferred to a federal district court in California for trial on that claim. The Jury returned a verdict against Kaiser. The district court in Florida granted summary Judgment against Kaiser on its section two claim.
The US court of appeal for 9th Circuit affirmed judgment entered on the Jury’s verdict on Kaiser’s section one claim. However, court reversed summary Judgment on Kaiser’s section two claim and remand for further proceedings.
The major issue was w.r.t polymorph patents of innovator abbot on Form IV of Terazosin hydrochloride, which was later found to be invalid. The Plantiff-appellent Kaiser alleged antitrust claims against generic player Geneva and innovator Abbot.

Opinion of Court

Cyclobenzaprine hydrochloride Extended-Release Capsules 15 mg and 30 mg (AMRIX): Innovator sued Impax

IMPAX Lab announced today that innovator Eurand, Inc., Cephalon, Inc., and Anesta AG have filed suit for patent infringement in the United States District Court for the District of Delaware based on the Company's submission of Abbreviated New Drug Application (“ANDA”) for Cyclobenzaprine hydrochloride Extended Release capsules (15 and 30 mg), generic of Amrix(R), to the Food and Drug Administration. Innovator alleged infringement of following Orange Book listed patent:
US7387793 (Expiry: February 26, 2025): Which covers a multi-particulate pharmaceutical dosage form of a skeletal muscle relaxant providing a modified release profile comprising a population of extended release beads, wherein said extended release beads comprise an active-containing core particle comprising a skeletal muscle relaxant selected from the group consisting of cyclobenzaprine, pharmaceutically acceptable salts or derivatives thereof and mixtures thereof; and an extended release coating comprising a water insoluble polymer membrane surrounding said core, wherein said dosage form when dissolution tested using United States Pharmacopoeia Apparatus 2 (paddles @ 50 rpm) in 900 mL of 0.1N HCl at 37.degree. C. exhibits a drug release profile substantially corresponding to the following pattern: after 2 hours, no more than about 40% of the total active is released; after 4 hours, from about 40-65% of the total active is released after 8 hours, from about 60-85% of the total active is released; wherein said dosage form provides therapeutically effective plasma concentration over a period of 24 hours to treat muscle spasm associated with painful musculoskeletal conditions when administered to a patient in need thereof; and wherein said water insoluble polymer membrane comprises a water insoluble polymer selected from the group consisting of ethers of cellulose, esters of cellulose, cellulose acetate, ethyl cellulose, polyvinyl acetate, neutral copolymers based on ethylacrylate and methylmethacrylate, copolymers of acrylic and methacrylic acid esters with quaternary ammonium groups, pH-insensitive ammonio methacrylic acid copolymers, and mixtures thereof; and a plasticizer selected from the group consisting of triacetin, tributyl citrate, tri-ethyl citrate, acetyl tri-n-butyl citrate, diethyl phthalate, dibutyl sebacate, polyethylene glycol, polypropylene glycol, castor oil, acetylated mono- and di-glycerides and mixtures thereof.‘793 patent is listed for 15 mg and 30 mg strengths of AMRIX (Cyclobenzaprine hydrochloride ER capsules). Eurand developed AMRIX based on its patented and proprietary drug delivery formulation technologies. Cephalon is the exclusive licensee and marketer of AMRIX in the United States. USFDA approved innovator’s product on Feb 1, 2007.Further, Cephalon has 3 years of marketing exclusivity (New dosage Form exclusivity) preventing USFDA approval of a generic version of AMRIX until February 1, 2010.
Innovator has earlier sued Mylan Pharma and Barr for the infringement of above patent in Delaware District Court in November, 2008. The generic players filed Para IV on August 11, 2008.

Amrix(R) is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.

Sun Pharma got final approval for Hydocodone Bitartate with Acetaminophen tab, Pamidronate inj, Gemfibrozil tab and Promethazin tab

Sun Pharmaannounced that together with its subsidiaries, it has received final approval from USFDA for it’s various Abbreviated New Drug Applications (ANDA). Approval was received for following generic formulations:

1. Hydocodone Bitartate with Acetaminophen (APAP) tablets

2. Pamidronate disodium (Aredia) for injection USP 30 mg/ vial and 90 mg/ vial

3. Gemfibrozil tablets (Lopid ) 600 mg

4. Promethazine hydrochloride (Phenargan) tablets 12.5 mg, 25 mg and 50 mg tablets.

Source: Sun Pharma press release Here

Drug Approvals (USA)

Final Approval

Coreg CR (carvedilol phosphate) Extended-Release Capsules:GlaxoSmithKline
Casodex (Bicalutamide) Tablets:AstraZeneca Pharmaceuticals
Zolpimist (zolpidem tartrate) Inhalation Spray: NovaDel Pharma

Desogestrel, Ethinylestradiol and Ethinyl Estradiol Tablets: Watson Laboratories
Gemfibrozil Tablets: Sun Pharmaceutical Industries

Glycopyrrolate Tablets: Vintage Pharmaceuticals
Nicotine Polacrilex Gum: Watson Laboratories

Risperidone Tablets: Vintage Pharmaceutical
Rocuronium Bromide Injection: APP Pharmaceuticals
Stavudine Capsules: Hetero Drugs Ltd, Matrix, Aurobindo.

Stavudine Oral Solution: Aurobindo Pharma

Vecuronium Bromide Injection: GeneraMedix

Tentative Approval

Ziprasidone Hydrochloride Capsules: Dr. Reddy’s Laboratories Ltd.,

Abacavir Sulfate and Lamivudine Tablets: Aurobindo Pharma Ltd

(Source: USFDA)

Atorvastatin (Lipitor): Pfizer succeded in patent re-examination of enantiomer patent

Innovator Pfizer announced that the USPTO has issued a “Notice of Allowance” accepting the company's application to correct the technical defect in the US5273995 enantiomer patent for atorvastatin calcium. The company noted that certain formalities must be completed before the reissue patent will be granted. The reissued patent will have the same force and effect as the original ˜995 patent and the same June 2011 expiration date.
There was technical defect in claim 2 of ‘995 patent which covers “[R-(R*R*)]-2-(4-fluorophenyl)-.beta.-.delta.-dihydroxy-5-(1-methylethyl)-3 -phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid”.
The claim 6 of this patent covers “ The hemi calcium salt of the compound of claim 2 (covers Atorvaststin Hemicalcium specifically)”
The claim 6 was dependent on claim 2, however, claim 2 covers acid and not salts, accordingly, The US court in 2006 held the ‘995 patent’s claim 6 as invalid due to wrong dependency (as the claim 2 covers acid form of Atorvastatin and not salt). After realizing its mistake, Pfizer tried to correct the mistake by requesting patent office to reissue the said patent after correction. Further, patent office twice rejected pfizer’s reissue application (latest in April, 2008 as reported by us Here), however, Pfizer this time was able to convince patent office for reissue.
The said reissue allowance will further strengthen Pfizer’s strategy to keep off generic challenge.
Atorvastatin Litigation update in US
Para IV filers :
1.Ranbaxy (First para IV filer)
2. Teva
3. Cobalt
4. Apotex
Generic player in litigation: Teva and Apotex
Settlement: 1. Ranbaxy has settled its pending patent litigation on Lipitor (as reported earlier Here) and Caudet on June 18, 2008 and will launch its generic product in November, 2011.
2. Cobalt has lost its patent litigation on '995 patent with Pfizer. Cobalt filed 505 (b) (2) with Atorvastatin sodium. Cobalt has agreed to launch it’s generic version after the expiry of ‘995 patent
Orange Book Patents in litigation
US4681893 (Expiry: 24 March, 2010)- Covers racemic form of Atorvastatin generically. Litigation update: Ranbaxy was unsuccessful in invalidating the said patent in US Court of Appeals For Federal Circuit (CAFC) in 2006. Further, during recent reexamination of ‘893 by USPTO on request from a Law firm representing Ranbaxy, the USPTO as per their May 2008 decision upheld the validity of ‘893 patent.
Earlier, Teva and cobalt has filed Para III against this patent. Probably, Apotex has also filed Para III against said patent
US5273995 (Expiry: 28th June, 2011) - Covers Atorvastatin enantiomer and salts as Product (Specifically)
Litigation update: 1. The patent was invalidated by CAFC in August 2006 (Particularly claim 6 of this patent)
2. Pfizer applied for reissue of the patent to USPTO, which was rejected twice by USPTO. On April 2008, USPTO again rejected Pfizer request. Subsequently, the patent was allowed in modified form.
3. In Caudet litigation Pfizer stated that it had issued ‘covenant not to sue’ (will not sue Ranbaxy for the infringement of said patent) to Ranbaxy, in case ‘995 patent is reissued to Pfizer
4. Innovator Pfizer sued Cobalt and Teva for the infringement of ‘995 patent
5. On 15 May 2008, Court entered Judgment in favor of Pfizer and delayed Cobalt ANDA approval till expiry of ‘995 patent
6. On Dec 17, 2008, Innovator sued Apotex for the infringement of ‘995 patent
US5686104 (Expiry: 11th May, 2015)- Covers stable Formulation
Litigation update: Pfizer has sued cobalt but not asserted patent during trial
US5969156 (Expiry: 8th June, 2017)- Polymorph (Form I, II and IV)
Litigation update: Pfizer has sued cobalt but not asserted patent during trial
US6126971 (Expiry: 19th July, 2013)- Covers stable formulation
Litigation update: Pfizer has sued cobalt but not asserted patent during trial
Other patents
US6087511 - which covers a process for the preparation of amorphous Atorvastatin where crystalline Form I of Atorvastatin is dissolved in a non-hydroxylic solvent and after removal of the solvent affords amorphous Atorvastatin
Litigation update: Pfizer had sued Ranbaxy in March, 2008. However, in June 2008 Ranbaxy settled with Innovator on this patent
US6274740 - which covers a process for the preparation of amorphous Atorvastatin or hydrates thereof which comprises: (a) dissolving crystalline Form I Atorvastatin in a non-hydroxylic solvent at a concentration of about 25% to about 40%; and (b) removing the solvent by drying to afford said amorphous atorvastatin or hydrates thereof
Litigation update: Pfizer had sued Ranbaxy in March, 2008. However, in June 2008 Ranbaxy settled with Innovator on this patent