Lupin got tentative approval for metformin ER tablets by USFDA

USFDA has given tentative approval to lupin for its AB rated generic equivalent of Andrx Labs LLC’s Fortamet 500mg and 1000 mg tablets, FORTAMET(R). Fortamet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.


As per Lupin's view, they are the first to file ANDA with paragraph IV certification, they will get the 180 days exclusivity on this product.  

Lupin settled patent litigation of Lunestawith Dainippon

Lupin Pharmaceuticals, indian pharma company, have ended  all ongoing litigation by the means of settlement over Lunesta (Eszopicolone) tablets, with Dainippon Sumitomo Pharma Co's subsidiary Sunovion Pharmaceuticals Inc.

AS per the settlement, Lupin can sell Lunesta's generic version from November 2013 or it may be extended by six months if pediatric extension will be granted to Lunesta

Lupin changed the way of out of court patent settlement

Till date whatever the out of court patent settlement was there, they were related to the patent which has been challenged by the parties through paragraph IV certification during ANDA filing.
Recently Lupin, an indian pharma major company has finalized a out of court patent settlement with Warner Chilcott as part of patent infringement suit for the oral contraceptive products (Loestrin 24 Fe and Femcon Fe). The main thing in this settlement is that the Lupin got the marketing rights for another product of Warner Chilcott for which Lupin had not filed any paragraph IV certification even. So Lupin get the rights to purchase and sell the authorized generic version of Asacol 400 (Mesalamine Delayed release tablets 400 mg) which is indicated for ulcerative colitis and has a reasonably good market of approx $700 million.
This will be the landmark out of court paten settlement for another pharma companies for such settlement.
(Source: www.business-standard.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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