Pentoprazole News

The fight on genric pentoprazole has started and generic players Teva, Sun Pharma, Caraco and innovator Wyeth has released following press releases
Sun Pharma launched Pentoprazole in USA
Sun Pharmaceutical Industries Ltd. announced today that it has commercially launched generic Pantoprazole Sodium Delayed Release (DR) Tablets, 40 mg, which is AB-rated to Wyeth's Protonix® DR Tablets. Sun's product is being sold in the United States by its marketing partner Caraco Pharmaceutical Laboratories. Sun Pharma had received a USFDA approval for these tablets in Sep 2007. This strength of Pantoprazole Sodium has annual sales of approximately USD 2.3 billion in the US.Sun's launch was initiated after the December 22, 2007 commercial launch by Teva Pharmaceutical Industries Ltd. of generic Pantoprazole Sodium tablet products, and after the January 29, 2008 commercial launch by Wyeth of generic Pantoprazole Sodium tablets product through its designated distributor.Sun shares a 180-day period of marketing exclusivity with Teva for this product. Sun is currently involved in patent litigation with Wyeth and Altana (now Nycomed) concerning this product in the U.S. District Court for the District of New Jersey. Although no trial date has yet been set, in September 2007, the District Court denied a motion filed by Wyeth and Altana for a preliminary injunction related to Sun's Pantoprazole Tablets. Wyeth and Altana have appealed the District Court's decision.

Caraco to market Sun Pharma Pentoprazole
Caraco Pharma announced today that it has launched Pantoprazole Sodium Delayed-Release Tablets, 40 mg (Pantoprazole Sodium DR), which is AB-rated to Wyeth's Protonix(R) DR Tablets, on behalf of Sun Pharmaceutical Industries, Ltd. (Sun Pharma). Sun Pharma recently received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Protonix(R), and being one of the first-to-file an ANDA with a Paragraph IV certification, shares a 180-day marketing exclusivity with Teva Pharmaceutical Industries Ltd.Caraco's launch on behalf of Sun Pharma was initiated after the December 22, 2007 launch by Teva Pharmaceutical Industries Ltd. of generic Pantoprazole Sodium DR tablet products, and after the January 29, 2008 launch by Wyeth of generic Pantoprazole Sodium DR tablets product through its designated distributor.Sun Pharma is currently involved in patent litigation with Wyeth and Altana (recently acquired by Nycomed) concerning this product in the U.S. District Court for the District of New Jersey. Although no trial date has yet been set, in September 2007, the District Court denied a motion filed by Wyeth and Altana for a preliminary injunction related to Sun's Pantoprazole Tablets. Wyeth and Altana have appealed the District Court's decision.Pantoprazole Sodium DR is indicated for the short-term treatment (up to eight weeks) in the healing and symptomatic relief of erosive esophagitis, is indicated for the maintenance of healing erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in patients with gastroesophageal reflux disease (GERD), and is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger- Ellison syndrome. This new product is bioequivalent to Protonix(R), a registered trademark of Wyeth Pharmaceuticals Inc. Protonix(R) 40 mg tablets had U.S. sales of approximately $2.3 billion for the 12-month period ended September 30, 2007, according to IMS Data.Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.

Prasco to distribute authorized generic Pentoprazole

Wyeth and its business partner, Nycomed, today announced the U.S. launch of Wyeth's own generic version of PROTONIX(R) tablets, in response to the at-risk launch of generic pantoprazole tablets in the U.S. by Teva Pharma, on December 21, 2007. Wyeth's own generic version of PROTONIX will be distributed by Prasco starting today."Compound patents, like that infringed by Teva, represent the foundation of pharmaceutical innovation, a critical underpinning in bringing important new medicines to patients," says Bernard Poussot, President and Chief Executive Officer for Wyeth. "We believe the PROTONIX compound patent is strong and we will vigorously pursue our litigation against Teva and other infringing generics. Going forward, we will continue to seek an injunction against any infringement of this patent, as well as monetary damages, including lost profits, from Teva."Wyeth and Altana Pharma AG (recently acquired by Nycomed) sued Teva and Sun Pharmaceuticals for patent infringement based on Teva's and Sun's filing of Abbreviated New Drug Applications (ANDAs) seeking U.S. Food and Drug Administration (FDA) approval to market generic versions of PROTONIX before the patent expires on July 19, 2010. Under the Hatch-Waxman Act, the filing of the lawsuit stayed final FDA approval of Teva's ANDA until August 2, 2007, and Sun's ANDA until September 8, 2007. On September 6, 2007, The United States District Court for the District of New Jersey denied Wyeth's and Nycomed's motion for preliminary injunction. The Court did not rule on the validity of the patent, but rather concluded that, based on the limited record before it, Wyeth and Nycomed were not entitled to the extraordinary relief of a preliminary injunction. Trial is expected in the second half of 2008.
Prasco announced today that, pursuant to an agreement it entered into with the ESI Lederle Division of Wyeth ("ESI"), it is shipping the generic version of PROTONIX(R) (Pantoprazole Sodium) Delayed-Release Tablets being offered for sale by ESI. Prasco, as ESI's agent and on ESI's behalf, will solicit orders for and distribute the 20 mg and 40 mg formulations of Pantoprazole Sodium Delayed-Release (DR) Tablets to all trade classes in the U.S. under the ESI Lederle label. Pantoprazole Sodium DR Tablets are AB-rated, therapeutically equivalent and substitutable for the brand PROTONIX Delayed-Release (DR) Tablets."We are extremely pleased to have established this agreement with Wyeth, a global leader in the pharmaceutical industry," said Prasco Chief Executive Officer E. Thomas Arington. "Pantoprazole Sodium DR Tablets are identical to PROTONIX DR Tablets, providing the consuming marketplace the benefits of competitive balance and brand-quality at generic prices," stated Arington.PROTONIX DR Tablets had reported sales of $2.5 billion dollars in the United States, with over 19 million prescriptions filled for the twelve months ended November 30, 2007, based on IMS sales data. PROTONIX is a registered trademark of Wyeth Pharmaceuticals, Inc.

Teva announced termination of agreement with Wyeth
Teva Pharma announced today that the Company's standstill agreement with Wyeth/Altana regarding additional shipments by Teva of generic Protonix (Pantoprazole Sodium) has terminated as a result of Wyeth's launch of an authorized generic product.Teva is currently involved in patent litigation with Wyeth/Altana concerning this product in the U.S. District Court for the District of New Jersey. A trial date has not been set.In September 2007, the District Court denied a motion filed by Wyeth/Altana for a preliminary injunction related to Teva's Pantoprazole Tablets. In that decision, the Court found that Wyeth/Altana did not meet its burden of proving likelihood of success on the merits. Wyeth/Altana have appealed that decision.