Sun Pharma loses $3-bn revenue potential from US Market followed by rejection of ANDA by USFDA

Sun Pharmaceutical Industries, India's largest drug maker has lost $3-billion revenue potential from the US market after a rival beat it to gain the US regulator’s approval to sell the world’s best-selling anti-depressant drug, Venlafaxine.

The US Food and Drug Administration (FDA) recently approved the generic of the tablet form of Effexor XR (Venlafaxine) to the US-based Osmotica Pharmaceutical's marketing application. The approval makes Sun Pharma's marketing application (abbreviated new drug application or ANDA) invalid.

Now, Sun Pharma will have to conduct fresh bio-equivalence study comparing with Osmotica's tablets and resubmit their ANDA, which effectively prevents its plans of launching the drug in the US market.

Effexor XR extended release drug in capsule form had annual sales of $3 billion for the month ended September 2008 and is the largest selling drug of Wyeth. Osmotica has already launched its tablet version following the product patent expiry of the basic ingredient in June, this year.

Unlike normal patent challenges by generic companies, Osmotica and Sun Pharma both developed an improvised tablet form of the drug and challenged the patent on basic ingredient venlafaxine, and not the original capsule version of the drug. While the product patents on Effexor are expected to expire by 2017, the patent on key ingredient venlafaxine expired this year.

Osmotica's generic version of Venlafaxine extended release tablets was approved by US FDA in May 2008 before Sun Pharma could get approval. Following this, Osmotica filed a citizen petition with US FDA directing all subsequent ANDA filers to resubmit their ANDA for proving bio-equivalence to Osmotica's tablet version, and not Wyeth's capsule version.

Though Sun Pharma had challenged the patents on three strengths of Effexor in 37.5 mg, 75 mg and 150 mg, based on an innovative technology for extended release tablets, Wyeth Pharmaceuticals did not sue Sun Pharma for infringing its patent and had issued a ‘covenant not to sue’ (a legal term in which an aggrieved party agrees not to sue the party liable to such action).

US generic drug major Mylan Pharmaceuticals is believed to be the first to file ANDA for this drug on capsule form. Wyeth had also entered into an out-of-court settlement with Teva Pharmaceuticals of the US for the same product in capsule form. However, Wyeth chose to sue other challengers such as India's Lupin Pharmaceuticals, Impax Laboratories, Anchen Pharmaceuticals and Alsa Corporation (a subsidiary of Johnson & Johnson) in the case of Effexor XR capsules.

 

 

DRL Launches Authorized Generic Version of Imitrex(R)* Tablets- Sumatriptan succinate

Dr. Reddy's Laboratories announced that it has launched the authorized generic version of GlaxoSmithKline's Imitrex(R) (sumatriptan succinate) tablets 25mg, 50mg, and 100mg in the United States. Dr. Reddy's is the first company to launch an authorized generic version of Imitrex(R) tablets in the US market.  In October 2006, the Company announced that it had settled patent litigation with GlaxoSmithKline relating to sumatriptan succinate tablets, the generic version of GlaxoSmithKline Imitrex(R) tablets.

 

 

 

Orion Sued Sun pharma for a key drug entacapone; a parkinson drug

Finnish drug firm Orion has filed a patent infringement lawsuit against Sun Pharma in the United States to protect its key drug Comtan, used for treatment of Parkinson's disease.

India's Sun Pharma Global is seeking to market a generic version of Comtan in the Unted States and has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking to sell the drug, Orion said.

"Comtan contains entacapone and is a product developed by Orion Corporation and marketed in the United States for the treatment of Parkinson's disease by its exclusive licensee, Novartis," Orion said in a statement.

Orion said by suing to enforce its patent it is entitled to an automatic stay prohibiting FDA from approving Sun Pharma Global's application for 30 months, or until an earlier court decision adverse to Orion's patent in the patent infringement lawsuit.

 

 

 

Lupin is going to launch new generation cardiac drug- Ivabradine

Business Standard reports that Mumbai-based drug major Lupin will launch a new generation cardio-vascular drug in India, aiming to tap the Rs 3,600-crore cardiac drug market.

Normally, the pulse rate of a high risk heart patient is above normal and this in turn increases the risk of a heart attack. The drug to be introduced by Lupin will help reduce the heart beat, thereby reducing the probability of a heart attack.

The Drug Controller General of India (DCGI) has given marketing approval for the drug, Ivabrad (Ivabradine) in 5mg and 7.5mg tablets.

“The drug will offer a new and innovative approach for the treatment of symptomatic stable angina in heart patients. We will price the drug in such a manner that it is affordable for Indian patients,” said Kamal K Sharma, managing director, Lupin.

India, which has over 60 million people suffering with heart diseases, has a cardiac drug market valued at Rs 3,600 crore, growing at a rate of 15 per cent every year.

Lupin is hoping to increase its current market share of 5.03 per cent (or revenue of Rs 175 crore) in this market. By 2010, over 100 million Indians are expected to be heart patients. The drug was originally developed by the France-based Servier Laboratories and was launched in February 2006 in the global markets. Lupin will launch the drug in India, with an exclusive arrangement with Servier.

 

Indian Drug Manufacturer Wockhardt has filed ANDA for Stalevo, a Parkinson's disease treating drug

Drug major Wockhardt has challenged the US patent of Stalevo, a new generation combination drug for the treatment of Parkinson's disease, originated by Finland-based Orion Corporation and marketed by Novartis.

Wockhardt has filed an abbreviated new drug-marketing application(ANDA) with the US Food and Drug Administration (FDA), seeking authorization to produce and market a generic version of Stalevo in 12.5, 200 and 50 mg strengths, said Orion Corporation. Approximately 6.5 million people worldwide suffer from Parkinson's disease, a disabling neurological condition. Stalevo simplifies the treatment process by combining levodopa, the most widely-used agent for treating Parkinson's disease, with enzyme inhibitors carbidopa and entacapone.