Hi-Tech Pharmacal entitled for 180 Day Exclusivity for Gabapentin Oral Solution

Hi-Tech Pharmacal Co., Inc.has received final approval for the Company’s Abbreviated New Drug Application, for gabapentin oral solution 250mg/5mL, which is the generic form of Pfizer’s Neurontin® oral solution,  Neurontin® is indicated for postherpetic neuralgia and epilepsy.


As the Hi-Tech Pharmacal Co., Inc. was first filer ANDA filer with Paragraph IV certification, received 180 days of exclusivity and planning to launch generic gabapentin oral solution immediately. Neurontin® had sales of $15 million for the 12 months ended December 2010 according to IMS sales data.

Lipitor: One more settlement in patent litigation

The highest sold drug in US is Lipitor and generics are behind that to make business. Earlier this drugs's patent was challenged by many including Ranbaxy and as a results few settled the case with some kind of agreement and few lost the case.

Recently Mylan Inc. has settled the lawsuit related to Lipitor with Pfizer. This agreement is under th e review of FTC and terms of settlement is not disclosed yet.

Pfizer sues Novartis over Vfend (Voriconazole) antifungal patents

Pfizer Inc. has sued Novartis' Sandoz unit, claiming infringement of its U.S. patents related to the antifungal treatment Vfend which contains Voriconazole as active agent.

Pfizer alleges that Sandoz is seeking permission from the U.S. Food and Drug Administration to sell a generic version of Vfend before the expiration of two patents issued in 1994 and 2003, respectively.

Pfizer in its complaint filed with the U.S. district court in Wilmington, Delaware has sought the court’s order to block Sandoz from selling any version of Vfend before the patents expire.
(Source: http://www.itagbs.com/weekly_news.html)

Pfizer Sues Actavis Group Over Lipitor Patent to Block Generic Copy

Pfizer Inc., the world’s largest drug company, sued Iceland’s Actavis Group hf asking a judge to block sales of a generic version of the cholesterol drug Lipitor until a patent expires in 2017.

New York-based Pfizer contends Actavis has applied to the U.S. Food and Drug Administration to make copies of the drug in violation of the 1999 patent, according to a complaint filed today in federal court in Wilmington, Delaware.

“Plaintiffs will be irreparably harmed” if Actavis markets its product before the patent-protection expires, Pfizer lawyers said in the complaint, which also seeks legal fees and expenses.

Lipitor is the best-selling medicine worldwide, with sales of $11.4 billion in 2009. Pfizer said July 6 it received approval from the European Commission for a new chewable form of Lipitor for children over age 10. (Source: www.bloomberg.com)

Lupin is going to sell different dosage form of Lipitor

The U.S. Food and Drug Administration has given permission to Indian generic-drug maker Lupin Ltd. to seek approval for a generic version of Pfizer Inc.'s blockbuster cholesterol drug Lipitor with a different formulation than the original drug.

The FDA decision, however, isn't likely to result in the introduction of the Lupin product anytime soon. Lupin still must go through the normal generic-drug approval process before it can launch its proposed capsule version of Lipitor--the original product is a tablet--and agency reviews can take upwards of two years.
Lipitor's impending loss of U.S. market exclusivity will be a major financial blow to Pfizer, which has cut costs and diversified its business lineup in preparation.
In 2008, Lupin filed a citizen petition with the FDA asking for permission seek approval of the capsule version of Lipitor. Lupin said it wanted to market a capsule version for people who have difficulty swallowing a tablet or prefer a capsule form.

The FDA last week granted Lupin's request, according to a letter posted online by the agency. The agency said Lupin's proposed capsule version of Lipitor wouldn't pose questions of safety or effectiveness, since the uses and oral route of administration are the same as the original tablet.
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Novartis Gets FDA Approval for Aliskiren-Amlodipine Combination

The FDA has approved Novartis’ Tekamlo, a pill containing its renin inhibitor Tekturna (aliskiren) and amlodipine (Pfizer’s Norvasc), as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals. It also works as replacement therapy for patients whose blood pressure is not adequately controlled with either aliskiren or amlodipine alone. For the drug to reach its full market potential, Novartis must release more outcome data, something it has committed to doing next year, Karl-Heinz Koch, an analyst at Sweden-based Helvea, said.
Form (Drug Industry Daily- fdanews)