Reddy’s set for brace of generic gains

Dr Reddy’s Laboratories (DRL) is set to reap yet another round of benefits from generics, with copies of Allegra and Lotrel expected to hit the market shortly.
Allegra, innovated by Aventis, is used to treat allergy and has brand sales of about $500 million in the US annually.

The Hyderabad-based drugmaker has been working on selling fexofenadine HCL, the generic version of Allegra, and has been going through the legal formalities for some time now.

“We have a tentative approval for the drug. But, we are still not talking about its launch,” a DRL spokesperson told DNA.

Launch of the Allegra generic could take some time.

Israel-based Teva Pharma recently arrived at a settlement with Sanofi Aventis, and will launch a D12 version of the drug (the other is D24) with 180-day exclusivity in November 2009.

After this period ends in April, analysts believe Dr Reddy’s and US-based Mylan Laboratories will have an edge over other expected rivals Impax and Sandoz.

They see Dr Reddy’s Allegra D12 clone hitting the market after the exclusivity period ends.

Analysts are also excited about Dr Reddy’s Allegra D24 version —- the company is believed to be the only one to have filed an abbreviated new drug application (ANDA) for this.  

A 30-month ANDA suspension on this version would conclude in the first quarter of 2010, allowing Dr Reddy’s to launch the product even at risk.

While generic Allegra 24’s market size is expected to be about $120 million, competition is likely to be limited in this segment, with not more than two players trying to make use of the opportunity.

“Surprise impediments (such as citizen’s petition, preliminary injunction) from Sanofi-Aventis could delay/ block Dr Reddy’s. There is also a possibility that Dr Reddy’s may settle with innovators,” said Sameer Baisiwala and Saniel Chandrawat of Morgan Stanley Research in a note last week. Meanwhile Lotrel, the Novartis drug to treate hypertension has estimated sales of about $600 million, according to Morgan Stanley.

Currently, Teva is the only generic player making this. Watson, Par, Lupin, Dr Reddy’s, Mylan and Cobalt are the others with an ANDA filing for the product.

Dr Reddy’s 30-month ANDA stay is expected to end in the first quarter of 2010.
For Dr Reddy’s limited competition is expected to come only from Mylan and Cobalt.
The company spokesman could not provide specific information on the Lotrel opportunity.