Galantamine HBr approval to Sun Pharma from USFDA

Sun Pharmaceutical Industries Ltd, a Gujarat based major pharma company has received an approval from the USFDA to sell generic drug galantamine hydrobromide used in treating mild to moderate Alzheimer's disease. The approvals are for multiple strengths of extended- release capsules, 8 mg (base), 16 mg (base) and 24 mg (base).

"The US Food and Drug Administration has granted its (Sun's) subsidiary an approval for an abbreviated new drug application (ANDA) to market a generic version of Razadyne ER, galantamine hydrobromide extended-release capsules," the company said in a statement. 

Razadyne ER is a registered trademark of Ortho-McNeil Janssen Pharmaceuticals and has an annual sale of around USD 50 million in the US.

Merck arm sues Sun for patent violation for Temodar

The Cancer Research Technology, a group company of Schering Plough Corp and a subsidiary of the US headquartered pharma giant Merck & Co, has alleged that Sun Pharma, by attempting to manufacture a generic version of cancer drug Temodar (Temozolomide), is infringing the patent coverage of the former.

Cancer Research has filed the suit against Sun Pharma in the US district court of New Jersey. The drug, which is one of the world's best selling brain cancer drug has annual sales worth $380 million in the US market alone and clocks global revenue of $1 billion per annum. The patent being challenged is set to expire in 2013.

Sun Pharma is not the first generic manufacturer to have filed an abbreviated new drug application (ANDA) related to the drug and therefore would not be entitled to most sought after 180 days of exclusive marketing opportunity for the drug. The patent related to drug is being litigated in the US courts since 2007.

The US-based Barr Labs was the first generic player to have received a tentative approval from the US Food and Drug Administration to manufacture this brain tumour drug. Later in 2008, Israeli drugmaker Teva acquired Barr. Temodar was developed by Schering-Plough Corp. Merck bought Schering-Plough in early 2009. So the litigation related to the drug is being pursued by Merck and Teva by virtue of their respective acquisitions.

In an important victory for Teva, last January, a federal court ruled that Merck's patent claims related to the concerned drug was ‘unenforceable’. Merck not only appealed against the decision, which is being heard currently in US courts (Federal Circuit), it also reached a settlement with Teva. The Israeli drugmaker, which had the option of launching the generic version of the drug in the US market, decided to hold off the launch post its agreement with Merck.

Teva said in March that it will begin selling its drug only if the court where a decision on the drug is pending, agrees that a patent on the brain cancer drug is unenforceable. In return, Merck agreed to allow Teva to start selling its generic in August 2013 if the patent is upheld. At that time Merck will still have pediatric exclusivity on the brain cancer treatment. (Source: http://www.financialexpress.com/)

Sun pharma gets another warning by FDA

Sun Pharmaceutical Industries Ltd. said Tuesday that its wholly owned U.S. unit, Sun Pharmaceutical Industries Inc., received a warning from the U.S. Food and Drug Administration related to manufacturing practices at a facility, making it the second instance of U.S. regulatory action against the Indian drug maker's U.S. units.

The Indian company suffered a profit decline in the last financial year as sales in the key U.S. market were hurt after the FDA found drug-manufacturing defects in 2009 at another U.S. unit, Caraco Pharmaceutical Laboratories Ltd. The FDA seized some drugs made by the U.S. unit at its facilities in Michigan and Caraco had to stop production there.

Sun Pharma said the warning letter to Sun Pharmaceutical Industries Inc. was issued as a follow-up to the last inspection of the unit's manufacturing facility at Cranbury, N.J., initiated in February. The FDA had identified violations of current good manufacturing practice regulations during the inspection, the statement added.

Sun Pharma said its unit has undertaken immediate corrective action. Sun Pharmaceutical's unit intends to respond promptly to the FDA within 15 working days, the statement said, adding it is committed to cooperating with the U.S. drug regulator to resolve the matters. The company warned that until its unit is able to satisfy the FDA with its responses, the regulator may in the near term withhold approval of pending new drug applications listing the Cranbury facility as the manufacturer.

Sun Pharma said it is maintaining its consolidated sales growth outlook for the current financial year that started April 1. The company had in May predicted sales growth of 18%-20% from last year.
(Source: The wall street journal)