Trial date set for CUBICIN® (daptomycin for injection) patent litigation

A trial date has been set for patent litigation in the U.S. District Court for the District of Delaware against Teva alleging infringement of Cubist's US Patent Nos. 6,468,967 and 6,852,689 (expiry September 24, 2019) and US Patent No. RE39,071 (expiry June 15, 2016). The Court has set a date for trial beginning on April 25, 2011. The court also scheduled a claim construction hearing (a.k.a. Markman hearing) for June 2, 2010. The court indicated that summary judgment motions will not be permitted in this lawsuit. Cubist filed the lawsuit in response to an ANDA filed by TPM seeking USFDA approval to market a generic version of daptomycin prior to the expiration of Cubist's patent rights. Daptomycin is marketed in the US and internationally under the brand name CUBICIN® (daptomycin for injection) as therapy for serious skin and bloodstream infections caused by certain Gram-positive bacteria.

Teva Launches Co-Beneldopa (Levodopa/Benserazide)

Teva UK Limited has launched the first generic co-beneldopa capsules in a variety of strengths. Co-beneldopa is a dopaminergic drug indicated for treatment of symptoms of Parkinson's disease. It is a generic version of Madopar(R) (co- beneldopa) made by Roche. It is available immediately in the award-winning Teva 360 livery, which is designed to aid patient safety.

Ranbaxy to launch olmesartan medoxomil in Kenya, Mozambique, Nigeria, Tanzania, Uganda and Zambia

Ranbaxy Labs is set to launch olmesartan medoxomil, an anti-hypertensive, under the brand name Olvance in six African countries viz., Kenya, Mozambique, Nigeria, Tanzania, Uganda and Zambia. The product is originally discovered by Daiichi. This is the first time in Africa that Daiichi and Ranbaxy are leveraging mutual synergies. Olmesartan medoxomil is a member of the Angiotensin receptor blocker (ARB) class of antihypertensive medications that help lower blood pressure by blocking the angiotensin II receptor on the blood vessels and antagonizing the release of hormone which causes salt retention and increased blood volume. Olmesartan medoxomil is available in more than 50 countries worldwide. Ranbaxy launched olmesartan medoxomil as Olvance in India in April 2009, followed by the August launch of Ol-Vamlo, a fixed-dose combination of olmesartan medoxomil with amlodipine besylate.

USFDA grants approval to Mylan's generic version of Keppra 1000mg

Mylan has received final approval from the USFDA for its ANDA for Levetiracetam Tablets, 1000 mg. Levetiracetam Tablets are the generic version of UCB Pharma's antiepileptic Keppra®. This additional strength of Levetiracetam Tablets complements Mylan's already approved and marketed strengths of 250 mg, 500 mg and 750 mg. Levetiracetam Tablets, 1000 mg had U.S. sales of approximately $136 million for the 12 months ending Sept. 30 and is shipping immediately.

Bayer withdraws MAA for Recothrom (thrombin alfa)

Bayer Schering Pharma has notified the EMEA of its decision to withdraw its application for a centralised marketing authorisation for the medicine Recothrom (thrombin alfa) 1,000 IU/ml. Recothrom was still under the review process by the CHMP at the time of withdrawl. In its official letter, the company stated that the withdrawal of the application was based on the concerns raised by the Committee regarding the choice of study population for the label in general surgery as well as the choice of comparator relative to the CHMP fibrin sealant guideline.

Free access Weblink to chemical molecules and associated patents

Ipblogger has come across a weblink under the link name http://www.chemspider.com/. The said weblink is a free access service providing a structure centric community for chemists. Providing access to millions of chemical structures and integration to a multitude of other online services, ChemSpider is the richest single source of structure-based chemistry information.

A simple or an advanced search for a particular molecule can provide the searcher a good deal of information pertaining to different chemical properties as well as patent information from the USPTO, EPO as well as PCT website. The search takes few seconds to complete. Interested scientist/chemist can further create an account and can also upload information. Although this is a free to access website but ipblogger would like to recommend the same to each and every scientist/chemist to try this website once.

Note: Ipblogger would like to specially acknowledge Mr. Ratish Acharya who provided the information about this website.

Cephalon files an infringement suit on Teva for NUVIGIL® (armodafinil) Tablets

Cephalon, Inc. it has filed a lawsuit in U.S. District Court in Delaware against Teva Pharmaceuticals USA, Inc. for infringement of U.S. Patent Nos. 7,132,570 (the "'570 Patent"), 7,297,346 (the "'346 Patent") and RE37,516 (the "'516 Patent") for the Cephalon product NUVIGIL® (armodafinil) Tablets [C-IV]. Cephalon has a three-year period of marketing exclusivity for NUVIGIL that extends until June 15, 2010. In addition, including the six-month pediatric extension, the '516 Patent, the '346 Patent, and the '570 Patent expire on April 6, 2015, May 29, 2024, and June 18, 2024, respectively.

Teva did not challenge Orange Book-listed U.S. Patent No. 4,927,855 (the "'855 Patent"), which provides additional protection until October 22, 2010, the expiration date of the '855 Patent. The lawsuit is based upon an Abbreviated New Drug Application (ANDA) filed by Teva seeking FDA approval for a generic equivalent of armodafinil to be sold in the United States. Teva alleges that the above NUVIGIL patents are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product described in its ANDA.

Abbott files infringement suit for paricalcitol against Teva

Abbott Laboratories et al. (Plaintiffs) have filed an infringement suit against Teva Parenteral Medicines Inc. et al (Defendants) for infringement of U.S. Patent Nos. 5,246,925 (“the ’925 patent”); 5,587,497 (“the ’497 patent”); and 6,136,799 (“the ’799 patent”). This action arises out of Teva’s filing of an Abbreviated New Drug Application (“ANDA”) seeking approval to sell a generic copy of Abbott’s highly successful Zemplar® injectable products prior to the expiration of patents owned by and exclusively licensed to Plaintiffs. The case was filed on November 19, 2009 in the District Court of Delaware. The details of the complaint are available here

Multaq(R) [Dronedarone] approved in the European Union

European Commission has granted marketing authorization for Sanofi's Multaq(R) (dronedarone - 400mg Tablets) in all 27 European member states. This approval follows the European Commission positive opinion issued on September 25, 2009 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine agency (EMEA). Multaq(R) is indicated in adult clinically stable patients with a history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate. Multaq(R) discovered and developed by sanofi-aventis is the first anti-arrhythmic drug approved in the European Union that has shown a clinical benefit to reduce cardiovascular hospitalizations or death from any cause in patients with AF/AFL as described in the ATHENA trial.

Sun Pharma recieves FDA approval for Nicardipine injection

Sun Pharma and its subsidiary has been granted approval for its application for Nicardipine Hydrochloride Injections by the USFDA. These Nicardipine Hydrochloride Injections are available as 25 mg/10ml single use ampuls containing 2.5 mg/ml of the drug, and have annual sales of approximately USD 170 million in the US. These injections are used for the short-term treatment of hypertension when oral therapy is not feasible or not desirable.