January 7, 2009: Sun Pharmaceutical Industries Ltd. announced that together with its subsidiaries, it has received final approval from USFDA for several Abbreviated New Drug Applications. Approval was received for generic hydocodone bitartate with acetaminophen (APAP) tablets. Approval was also received for generic Aredia, pamidronate disodium for injection USP, generic Lopid, gemfibrozil tablets, USP, and generic Phenargan, promethazine hydrochloride tablets.
The details can be read here.
Wednesday, January 7, 2009
Tuesday, January 6, 2009
U.S. Patent and Trademark Office Accepts Pfizer's Reissue Application on Lipitor Enantiomer Patent
Jan 6, 2009 - Pfizer Inc announced today that the U.S. PTO has issued a “Notice of Allowance” accepting the company's application to correct the technical defect in the ˜995 enantiomer patent for atorvastatin calcium, the salt form of atorvastatin sold as Lipitor. 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 (including the six-month pediatric exclusivity period).
The details can be read here.
The details can be read here.
Monday, January 5, 2009
USPTO Denies PTE for PRILOSEC OTC
As per the post published on FDA law Blog by Mr. Kurst R Karst
USPTO has finalized the determination that U.S. Patent 5817338, which covers AstraZeneca’s PRILOSEC OTC (omeprazole magnesium) Delayed-Release Tablets, is not eligible for a Patent term Extension (“PTE”) because the PRILOSEC OTC New Drug Application was not the first permitted commercial marketing or use of omeprazole, and because the PTE application was not timely submitted. (The PTE application was submitted on the 61st day after the date of NDA approval).
The details can be read here.
The decision can be read here.
USPTO has finalized the determination that U.S. Patent 5817338, which covers AstraZeneca’s PRILOSEC OTC (omeprazole magnesium) Delayed-Release Tablets, is not eligible for a Patent term Extension (“PTE”) because the PRILOSEC OTC New Drug Application was not the first permitted commercial marketing or use of omeprazole, and because the PTE application was not timely submitted. (The PTE application was submitted on the 61st day after the date of NDA approval).
The details can be read here.
The decision can be read here.
Govt finalises Rs 441 cr IDPL revival package, GoM to meet soon
The much-awaited Rs 441-crore financial package to revive the ailing Indian Drugs and Pharmaceuticals Ltd (IDPL) has been finalised and the government departments, involved in the process, are giving final fine-tuning to the package.
The details can be read here.
The details can be read here.
Genta Summarizes Phase 2 Activity and Receives Orphan Drug Designation in Gastric Cancer for Tesetaxel, a Leading Oral Taxane in Clinical Development
January 5, 2009 – Genta Incorporated announced today that the Company has received notice from the U.S FDA that tesetaxel, the latest addition to Genta’s oncology product portfolio, has been granted designation as an “Orphan Drug” for treatment of patients with advanced gastric cancer.
The details can be read here.
The details can be read here.
New Drug Application Submitted For Acurox Tablets
Jan. 2, 2009 -- Acura Pharmaceuticals, Inc. and King Pharmaceuticals, Inc. (NYSE:KG) today announced that Acura has submitted a New Drug Application for Acurox (oxycodone HCl/niacin) Tablets to the U.S. FDA including a request for priority review.
The details can be read here.
The details can be read here.
Prism Pharmaceuticals Receives FDA Approval of Nexterone for Life-Threatening Ventricular Fibrillation and Ventricular Tachycardia
January 05, 2009 -- Prism Pharmaceuticals announced today that the U.S. FDA has approved the new drug application for NEXTERONE (amiodarone HCl) Injection, a novel, patent-protected, cosolvent free formulation of the antiarrhythmic agent Amiodarone I.V., originally marketed in the US by Wyeth as Cordarone Intravenous.
The details can be read here.
The details can be read here.
CyDex Pharmaceuticals Announces Captisol Technology Used in Recently Approved Cosolvent-Free Formulation of Amiodarone I.V.
Jan 5, 2009 - CyDex Pharmaceuticals, Inc. today announced that Prism Pharmaceuticals' NEXTERONE, which recently received new drug application (NDA) approval from the U.S. FDA, is based on the patent-protected CyDex CAPTISOL technology platform. NEXTERONE is the first CyDex proprietary product to achieve the milestone of NDA approval.
The details can be read here.
The details can be read here.
BioSante Pharmaceuticals Announces Issuance of New Patent Covering Elestrin
Jan 5, 2009 - BioSante Pharmaceuticals, Inc. announced that a new patent has issued covering Elestrin (estradiol gel), which is approved in the U.S. for moderate-to-severe vasomotor symptoms, known as hot flashes, associated with menopause. BioSante received approval of Elestrin from the U.S. FDA in December 2006.
The details can be read here.
The details can be read here.
Alexion Pharmaceuticals and PDL BioPharma Resolve Patent Dispute
January 05, 2009 -- PDL BioPharma, Inc. and Alexion Pharmaceuticals, Inc. today jointly announced that the companies have entered into a definitive license agreement and settlement agreement that resolve the legal disputes between them relating to Alexion's humanized antibody, Soliris (eculizumab) and PDL's patents known as the Queen et al. patents.
The details can be read here.
The details can be read here.
Sunday, January 4, 2009
COURT REPORT
About Court Report: Each week http://www.patentdocs.org/ report briefly on recently filed biotech and pharma cases, and they select few interesting cases for periodic monitoring.
Monsanto Co. et al. v. Pilman4:08-cv-02020; filed December 30, 2008 in the Eastern District of Missouri
Warner Chilcott Laboratories Ireland Ltd. et al. v. Impax Laboratories, Inc. et al.2:08-cv-06304; filed December 23, 2008 in the District Court of New Jersey
The details and the complaint can be read here.
Monsanto Co. et al. v. Pilman4:08-cv-02020; filed December 30, 2008 in the Eastern District of Missouri
Warner Chilcott Laboratories Ireland Ltd. et al. v. Impax Laboratories, Inc. et al.2:08-cv-06304; filed December 23, 2008 in the District Court of New Jersey
The details and the complaint can be read here.
Ranbaxy's failed to launch generic Imitrex in December
In an interesting piece of news reported by Khomba Singh of Economic Times, India’s largest drug manufacturer Ranbaxy has strangely missed their expected December 2008 deadline to launch generic version of Glaxo’s blockbuster anti-migraine drug Imitrex, generically known as Sumatriptan Succinate in the United States. ....
The details can be read here.
The news from Economic Times can be read here.
The details can be read here.
The news from Economic Times can be read here.
Share values of 23 major pharma cos decline by 33% during 2008
The year 2008 is marked by volatile movements on the stock market with heavy selling pressure by foreign financial institutions and general investors on account of recessionary conditions worldwide. The BSE Healthcare index of 23 major pharmaceutical companies drifted down by 33 per cent to 2966.19 as at the last day of 2008 as compared to 4418.65 points at the end of year 2007. However, the there was small gain across the counters on the first trading day of 2009 with little investors support.
The details can be read here.
The details can be read here.
Expert panel on FDC likely to meet on Jan 16-17
the expert panel on fixed dose combination (FDC), formed to resolve the lingering FDC issue, is likely to have its first meeting on January 16 and 17. The first meeting, which will be attended by senior health ministry officials including the DCGI and representatives of industry associations, will decide the fate of 43 of the remaining 156 combination drugs, it is learnt.
The details can be read here.
The details can be read here.
Watson receives US FDA marketing nod for mint coated Nicotine Gum
Watson Pharmaceuticals, Inc, a leader in generic and specialty branded pharmaceuticals, announced that its subsidiary, Watson Laboratories, Inc, has received approval from the United States Food and Drug Administration to market its over-the-counter Nicotine Polacrilex Gum USP, coated mint flavour, in the 2 mg and 4 mg strengths.
The details can be read here.
The details can be read here.
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