AstraZeneca settles U.S. Pulmicort Respules patent infringement litigation against Ivax Pharmaceuticals
An intra cellular pathway not previously linked to breast cancer is driving a sub-type of the disease that is highly lethal and disproportionately over-represented in African American women. The pathway regulates how cells identify and destroy proteins and represents a class of genes called proteasome targeting complexes. The work shows that basal cancer cells degrade
Full Post: Scientists find intra cellular pathway driving a deadly sub-type of breast cancer
AstraZeneca has announced it has entered into a settlement agreement in its Pulmicort Respules patent infringement litigation against Ivax Pharmaceuticals, Inc., a wholly owned subsidiary of Teva Pharmaceuticals USA.
The agreement settles the patent infringement litigation filed by AstraZeneca following Teva’s submission to the United States Food & Drug Administration of an Abbreviated New Drug Application for a generic version of Pulmicort Respules. Under the settlement agreement, Teva concedes that the patents asserted by AstraZeneca in the patent litigation are valid and enforceable. Teva also concedes that its generic version of Pulmicort Respules infringes AstraZeneca’s patents.
The settlement agreement will allow Teva to commence sales of budesonide inhalation suspension, a generic version of Pulmicort Respules, under an exclusive license from AstraZeneca beginning 15 December 2009. AstraZeneca will receive a significant undisclosed royalty on sales of Teva’s product, with a marked step down in payments if additional at-risk generic products enter the marketplace. Teva also agrees to pay AstraZeneca an undisclosed sum in respect of damages resulting from the unauthorised launch of its generic budesonide inhalation suspension product on 18 November 2008. Except as described, the terms of the settlement are confidential. The agreement releases Teva from all past US sales of its generic budesonide inhalation suspension and provides that any product already shipped by Teva will remain in the market to be further distributed and dispensed.
AstraZeneca intends to continue to sell Pulmicort Respules, even after the licensed entry of Teva’s product in December 2009. However, the separate agreement between AstraZeneca and Par Pharmaceuticals to make available an authorized generic version of Pulmicort Respules will be discontinued.
AstraZeneca and Teva have filed a Consent Judgment with the US District Court for the District of New Jersey reflecting the terms of the settlement agreement. With the Court now having entered the Consent Judgment, the settlement agreement is final, and the patent infringement litigation against Teva has been dismissed.
With this announcement AstraZeneca confirms that it continues to expect Core earnings per share in the range of $4.90 to $5.05 for the full year 2008. Actual performance within this range is dependent upon the performance of the business for the remainder of the year, including the potential negative impact on sales of Pulmicort Respules from Teva’s generic product and the small amount of authorised generic already in trade channels. AstraZeneca will address the 2009 outlook for Pulmicort Respules as part of the full year 2009 guidance in January.
As a reminder, the company’s full year guidance reflects actual results for the first nine months, combined with guidance for the fourth quarter based on the original assumptions for currency, being fourth quarter 2007 average exchange rates.
“This agreement provides increased certainty and stability in our business and a clearer backdrop for our investment decisions while re-affirming the strength of our intellectual property,” said David Brennan, Chief Executive Officer of AstraZeneca.
AstraZeneca’s Pulmicort Respules patent infringement litigation against Breath Limited remains ongoing. In compliance with the Medicare Modernization Act of 2003, AstraZeneca will file all of the above agreements with the United States Federal Trade Commission and the United States Department of Justice.
AstraZeneca’s patents protecting Pulmicort Respules have expiration dates that extend through 2018, with pediatric exclusivity through 2019.
Teva Pharmaceutical Industries Ltd. has announced that its subsidiary, Teva Pharmaceuticals USA, Inc., has signed an agreement with AstraZeneca to settle patent litigation involving Teva’s U.S. generic version of AstraZeneca’s Pulmicort (Budesonide) Respules including all claims for patent infringement and damages. Teva launched its generic budesonide respules in the U.S. on November 18, 2008. The
Full Post: Teva announces agreement on generic Pulmicort Respules patent challenge
Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc. has entered into separate settlement agreements related to ongoing patent challenges for Nasacort AQ (triamcinolone acetonide) nasal spray, Allegra D-12 Hour (fexofenadine hydrochloride 60mg and pseudoephedrine hydrochloride 120mg) extended-release tablets, and Allegra (fexofenadine) 30mg, 60mg and 180mg tablets. As part of the settlements, the
Full Post: Barr announces agreements on Nasacort AQ, Allegra D-12 and Allegra patent challenges
Teva Pharmaceutical Industries Ltd. and Barr Pharmaceuticals, Inc. have announced that they received approval from the European Commission to proceed with Teva’s acquisition of Barr. In connection with this approval, Teva and Barr are required to divest certain formulations of 17 generic drugs in certain specific countries with respect to which they have a product
Full Post: Teva and Barr receive European approval for acquisition
Codexis, Inc. today announced a licensing agreement with Teva Pharmaceutical Industries Ltd., to produce an important publicly-undisclosed generic product, using a proprietary Codexis biocatalyst. Teva, the largest generic drug manufacturer in the world, is a leading producer of this generic product. The product is one of the largest- selling generic prescription drugs in the United
Full Post: Codexis announces licensing agreement with Teva Pharmaceutical Industries
Mylan Inc. has announced that it and its subsidiary, Mylan Pharmaceuticals Inc., have entered into a settlement agreement with Novartis Pharmaceuticals Corp., Novartis Corp. and Novartis International AG related to Letrozole Tablets, the generic version of Novartis’ Femara. Mylan’s Vice Chairman and CEO Robert J. Coury commented: “We are very pleased to have reached this
Full Post: Mylan settles with Novartis on Femara