Protonix News and Research

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U.S. District Court upholds validity of Nycomed's Protonix patent

Nycomed announced today that Judge Jose L. Linares of the U.S. District Court for the District of New Jersey has confirmed the jury verdict in favor of Nycomed and Pfizer Inc. The decision upholds the jury verdict issued on April 23, 2010, confirming that the patent is valid and rejecting allegations by the defendants that the patent was invalid as obvious and invalid for double patenting. Against KUDCo, the US generic drug business of the Schwarz Pharma Group, which did not at-risk launch, final Judgment was entered as a result of Judge Jose L. Linares' rulings.

19 Jul 2010

New Jersey District Court denies Teva's motion to overturn jury verdict in generic Protonix litigation

Teva Pharmaceutical Industries Ltd. announced today that the U.S. District Court for the District of New Jersey denied Teva's motion to overturn an April 23, 2010, jury verdict finding the patent in suit not invalid. The Court also denied Wyeth and Nycomed's request for FDA to reset the date of Teva's final approval to January 2011, based on the fact that Teva has patent defenses remaining at the District Court, including patent misuse.

17 Jul 2010

Teva launches antidepressant Venlafaxine HCl ER Capsules

Teva Pharmaceutical Industries Ltd. announced today that it has commenced commercial launch of Venlafaxine HCl ER Capsules, the Company's generic version of Wyeth's antidepressant Effexor XR®. The brand product had annual sales of approximately $2.75 billion in the United States, based on IMS sales data.

2 Jul 2010

FDA approves Teva's generic Effexor XR antidepressant

Teva Pharmaceutical Industries Ltd. announced today U.S. Food and Drug Administration (FDA) approval of Venlafaxine HCl ER Capsules, the Company's generic version of Wyeth's antidepressant Effexor XR®. Shipment is expected to commence on July 1, 2010, as per the terms of the 2006 agreement with Wyeth.

29 Jun 2010

Bayer signs agreement to supply Adalat XL product to Teva Canada

Bayer Inc. and Teva Canada Limited today announced they have entered an agreement regarding Bayer's Adalat XL (nifedipine) 20, 30 and 60 mg product. Effective immediately, Bayer Inc. will supply Adalat XL exclusively to Teva Canada Limited and Teva Canada Limited will become the sole distributor in Canada of brand name Adalat XL product.

28 Jun 2010

Teva closes $2.5 billion Senior Notes offering

Teva Pharmaceutical Industries Limited announced today that it has closed the previously announced offering, by its special purpose finance subsidiaries, of a debt offering in three tranches:

19 Jun 2010

Teva prices $2.5 billion debt offering

Teva Pharmaceutical Industries Limited announced today that it successfully priced the offering, by its special purpose finance subsidiaries, of a debt offering in three tranches:

16 Jun 2010

Intellipharmaceutics International files Protonix ANDA with FDA

Intellipharmaceutics International Inc. today announced that is has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration for a generic of Protonix® (delayed release pantoprazole sodium). Protonix inhibits gastric acid secretion and is prescribed for the short-term treatment of conditions such as stomach ulcers associated with gastroesophageal reflux disease as well as the long term treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome.

14 Jun 2010

Teva reports encouraging data from study assessing new lower-volume injection of Copaxone at 24th CMSC

Teva Pharmaceutical Industries Ltd. today announced positive results from a study assessing a new lower-volume injection of Copaxone® (glatiramer acetate) containing the currently approved dose in half the injection volume.

5 Jun 2010

Study confirms Azilect as a selective MAO-B inhibitor

Teva Neuroscience Inc. today announced the publication of a study demonstrating the selectivity of Azilect® (rasagiline tablets) for inhibition of MAO-B (monoamine oxidase-B) at the maximum approved dose of 1 mg/day. The data was published in the Journal of Clinical Pharmacology OnlineFirst on May 5, 2010.

4 Jun 2010

Teva Pharmaceutical launches Gianvi Tablets

Teva Pharmaceutical Industries Ltd. announced today that it has commercially launched Gianvi (Drospirenone and Ethinyl Estradiol) Tablets, the Company's generic version of Bayer's Yaz® Tablets.

2 Jun 2010

$FDA warns on possible fracture risk with proton pump inhibitors use$

FDA warns on possible fracture risk with proton pump inhibitors use

The U.S. Food and Drug Administration today warned consumers and health care professionals about a possible increased risk of fractures of the hip, wrist, and spine with high doses or long-term use of a class of medications called proton pump inhibitors. The product labeling will be changed to describe this possible increased risk.

26 May 2010

Drug trend for children increased 10.8% in 2009 across America

In growing numbers, children across America are adding a dose of medicine to their daily routine. In 2009, drug trend for children – a measure of prescription spending growth – increased 10.8 percent, driven by a 5 percent increase in drug utilization and higher medication costs, according to the Medco 2010 Drug Trend Report. The growth in prescription drug use among children was nearly four times higher than the rise seen in the overall population.

20 May 2010

Teva agrees to settle patent litigation regarding generic version of AstraZeneca's Entocort EC capsules

Teva Pharmaceutical Industries Ltd. announced today that it has entered into an agreement with AstraZeneca to settle patent litigation regarding Teva's U.S. generic version of AstraZeneca's Entocort EC (budesonide) capsules.

18 May 2010

Phase II ALSTAR trial: Talampanel is safe for ALS patients

Teva Pharmaceutical Industries Ltd. today announced results from the Phase II ALSTAR trial. The trial was designed to assess efficacy, safety and tolerability of Talampanel (a selective AMPA antagonist) in reducing disease-related functional deterioration in Amyotrophic Lateral Sclerosis patients.

18 May 2010

FDA grants tentative approval for Teva's Cinacalcet HCl Tablets ANDA

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Cinacalcet HCl Tablets 30, 60 & 90 mg.

15 May 2010

R.I. overhauls Medicaid payments for elderly, disabled; Medicaid delays reported in Kansas

Rhode Island received a waiver from the Bush administration to revamp its Medicaid program for the elderly and disabled, despite concerns from "community health activists [who] feared that it would push some of the neediest onto waiting lists or worse — throw some poor people off the Medicaid rolls altogether.

12 May 2010

Teva reports 31% increase in non-GAAP net income for first-quarter 2010

Teva Pharmaceutical Industries Ltd. today reported results for the quarter ended March 31, 2010.

4 May 2010

New Jersey District Court jury finds Nycomed's U.S. Patent No. 4,758,579 not invalid: Teva

Teva Pharmaceutical Industries Ltd. announced today that a jury returned a verdict in the U.S. District Court for the District of New Jersey finding that Nycomed's U.S. Patent No. 4,758,579 is not invalid. The Court has reserved decision on the issue of what, if any, effect to give to the jury's determinations in connection with the obviousness-type double patenting defenses, which Teva has argued is to be decided by the Court.

24 Apr 2010

Teva Pharmaceutical Industries presents ADAGIO study results at AAN Annual Meeting

Teva Pharmaceutical Industries Ltd. today announced results from the placebo group analyses of the ADAGIO study that were presented at the 62nd Annual Meeting of the American Academy of Neurology. The ADAGIO study stands out from other Parkinson's disease trials as it is the largest clinical study conducted in patients who were still in the very early stages of their disease course (average time from PD diagnosis of 4.5 months).

20 Apr 2010