Refer to our earlier news on Atripla Here , wherein, we reported Para IV filing by Teva pharma on Efavirenz (600 mg) + Emtricitabine (200 mg) + Tenofovir Disoproxil Fumarate (300) mg (Atripla). After receipt of Para IV notice letter, innovator Gilead Sciences announced (in a press release Here ) that it has filed a lawsuit in U.S. District Court in New York against Teva Pharma for infringement of following Orange Book listed patents for Atripla [(Efavirenz (600 mg) + Emtricitabine (200 mg) + Tenofovir Disoproxil Fumarate (300) mg]:
US6642245 (Expiry: May 4, 2021): which covers a method for treating HIV infection in humans comprising administering an effective amount of (-)-.beta.-L-2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane, or its physiologically acceptable salt, optionally in a pharmaceutically acceptable carrier.
US6703396 (Expiry: Sep 9, 2021): which covers a (-)-enantiomer of cis-4-amino-5-fluoro-1-(2-hydroxymethyl-1,3-oxathiolane-5-yl)-(1H)-pyrimid in-2-one that is at least 95% free of the corresponding (+)-enantiomer
Teva has challenged above patents by sending Para IV letter to innovator, wherein , Teva alleged that patents on Emtricitabine are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product described in its ANDA submission:
Earlier, Teva challenged the validity of ‘245 and ‘396 Emtricitabine patents with an ANDA filing for Truvada® (Emtricitabine and Tenofovir disoproxil fumarate)The antiviral combination is currently sold in the United States through a joint venture between Bristol-Myers Squibb (BMS) and Gilead.
Monday, 18 May 2009
Efavirenz (600 mg) + Emtricitabine (200 mg) + Tenofovir Disoproxil Fumarate (300 mg) (Atripla):Innovator Files Second Patent Infringement Lawsuit
Wednesday, 8 April 2009
Efavirenz (600 mg) + Emtricitabine (200 mg) + Tenofovir Disoproxil Fumarate (300 mg) (Atripla):Innovator Gilead Confirmed Receipt of Para IV Letter
Innovator Gilead Sciences confirmed (in a press release Here ) the receipt of a Paragraph IV Certification Notice Letter from generic player Teva Pharma on Efavirenz (600 mg) + Emtricitabine (200 mg) + Tenofovir Disoproxil Fumarate (300) mg (Atripla). The antiviral combination is currently sold in the United States through a joint venture between Bristol-Myers Squibb (BMS) and Gilead.
In the Notice Letter, Teva alleges that following two Orange Book listed patents associated with Emtricitabine are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product described in its ANDA submission:
US6642245 (Expiry: May 4, 2021): which covers A method for treating HIV infection in humans comprising administering an effective amount of (-)-.beta.-L-2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane, or its physiologically acceptable salt, optionally in a pharmaceutically acceptable carrier.
US6703396 (Expiry: Sep 9, 2021): The (-)-enantiomer of cis-4-amino-5-fluoro-1-(2-hydroxymethyl-1,3-oxathiolane-5-yl)-(1H)-pyrimid in-2-one that is at least 95% free of the corresponding (+)-enantiomer
Earlier, Teva challenged the validity of these same two Emtricitabine patents with an ANDA filing for Truvada® (Emtricitabine and Tenofovir disoproxil fumarate) as reported by us Here. Subsequently, Innovator Gilead sued Teva in District Court in New York.
Earlier news of IPPharmadoc on this product Here
Wednesday, 21 May 2008
USPTO upheld one Viread (Tenofovir Disoproxil Fumarate) patent
The USPTO has not announced its ruling on the remaining three Viread patents under review, the company said.
The nonprofit Public Patent Foundation had challenged the Viread patents last year. The group said it submitted evidence that patent on Viread are obvious as per prior art.
Tenofovir disoproxil fumarate ( 1-(6-aminopurin-9-yl) propan-2-yloxymethylphosphonic acid ), belongs to a class of antiretroviral drugs known as nucleotide analogue reverse transcriptase inhibitors (nRTIs), which block reverse transcriptase, an enzyme crucial to viral production in HIV-infected people.
Tenofovir is also available in a fixed-dose combination with emtricitabine in a product with the brand name Truvada for once-a-day dosing. (Emtricitabine is marketed as a single-compound product called Emtriva, also by Gilead.) Atripla, a fixed-dose triple combination of tenofovir, emtricitabine and efavirenz, was approved by the FDA on 12 July 2006 and is now available, providing a single daily dose for the treatment of HIV.
Monday, 17 November 2008
Emtricitabine and Tenofovir disoproxil fumarate (Truvada): Innovator confirmed reciept of Para IV letter from Teva
In the Notice Letter, Teva alleges that following two patents associated with Emtricitabine:
US6642245 (Expiry: May 4, 2021): which covers A method for treating HIV infection in humans comprising administering an effective amount of (-)-.beta.-L-2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane, or its physiologically acceptable salt, optionally in a pharmaceutically acceptable carrier.
US6703396 (Expiry: Sep 9, 2021): The (-)-enantiomer of cis-4-amino-5-fluoro-1-(2-hydroxymethyl-1,3-oxathiolane-5-yl)-(1H)-pyrimid in-2-one that is at least 95% free of the corresponding (+)-enantiomer
Patented by Emory University and licensed exclusively to Gilead Sciences are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product described in its ANDA submission.
Gilead is currently reviewing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Teva. Such a lawsuit would restrict the FDA from approving Teva's ANDA for up to 30 months or until a district court decision that is adverse to Gilead, whichever occurs first. Truvada is currently protected by 10 patents, which are listed in the FDA's Approved Drugs Products List, and all 10 patents would need to be invalidated or expired before a generic version of Truvada could be marketed. USFDA approved this combination on Aug 2, 2004.
Tuesday, 18 December 2007
European Commission Approves ATRIPLA®
"Historically, HIV treatment regimens have been a challenge for many patients since they often combine multiple medications with complex dosing schedules," said Brian Gazzard, MD, Clinical Research Director, Chelsea and Westminster Hospital, London. "ATRIPLA combines three clinically proven and well-established anti-HIV medicines in a single once-daily pill and represents an important step forward in dosing simplification."
ATRIPLA has been approved in the European Union for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults with virologic suppression to HIV-1 RNA levels < 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harbored virus strains with mutations conferring significant resistance to any of the three components contained in ATRIPLA prior to initiation of their first antiretroviral treatment regimen.
Efavirenz is marketed by Bristol-Myers Squibb Company (NYSE: BMY) under the tradename SUSTIVA® in the United States, Canada and six European countries (France, Republic of Ireland, Germany, Italy, Spain and the United Kingdom). Efavirenz is commercialized by Merck & Co., Inc, through its affiliate Merck Sharp & Dohme (MSD) Limited under the tradename STOCRIN® in all other countries within the European Union and many countries outside of the United States. Emtricitabine and tenofovir disoproxil fumarate are commercialized by Gilead Sciences, Inc. (NASDAQ: GILD) under the tradenames Emtriva® and Viread®, respectively, and are commonly prescribed together as a once-daily, fixed-dose tablet, marketed under the tradename Truvada® for use as part of combination therapy.
The marketing authorization application for ATRIPLA in the European Union was filed by a three-way joint venture based in Ireland called Bristol-Myers Squibb Gilead Sciences And Merck Sharp & Dohme Limited.
ATRIPLA is currently the first and only once-daily single tablet regimen approved for the treatment of HIV-1 infection in adults in the United States for use either as stand-alone therapy or in combination with other antiretroviral agents. ATRIPLA was approved by the U.S. Food and Drug Administration in July 2006 and has since become the most-prescribed treatment regimen for patients starting HIV therapy in the United States.
As the commercial launch of ATRIPLA in the countries of the European Union is not anticipated to begin until the early part of 2008, Gilead is not making any adjustments to the full year 2007 Product Revenue guidance provided on the third quarter 2007 earnings conference call on Oct. 18, 2007. Gilead is also not making adjustments to any of the other elements of guidance, including its updated Research & Development guidance of a range from $510 million to $520 million provided on Nov. 6, 2007, which includes the up front licensing payment related to LG Life Sciences collaboration for the caspase inhibitor.
Thursday, 5 February 2009
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
