The Indian-based company announced on 18 November 2010 that it had received approval from the FDA for its Abbreviated New Drug Applications (ANDAs) for generic versions of Biovail Corporation’s Tiazac (diltaizem hydrochloride) extended release capsules and Schering Plough’s Clarinex (desloratadine) tablets 5 mg.

Diltiazem hydrochloride is a calcium channel blocker which works by relaxing the muscles of the heart and blood vessels. It is indicated for the treatment of hypertension (high blood pressure) and angina (chest pain).

Desloratadine is an antihistamine indicated in the treatment of seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria.

Then on 24 November 2010, Sun Pharma also announced that it had received tentative approval from the FDA for its ANDA for a generic version of Eli Lilly’s Cymbalta (duloxetine hydrochloride) delayed-release capsules, in various dosages.

Duloxetine hydrochloride is indicated in the treatment of major depressive disorder, generalized anxiety disorder and diabetic peripheral neuropathic pain.

Sales of diltaizem hydrochloride capsules and the 5 mg strength of Clarinex have annual US sales of approximately US$46 million and US$212 million, respectively, while Cymbalta has staggering annual US sales of approximately US$3 billion.

Sun Pharma is not alone, however, in targeting the lucrative Cymbalta market, as IMPAX Laboratories also announced on 22 November 2010 that they had received tentative approval of their ANDA for a generic version of Cymbalta.

The tentative approval of generic duloxetine hydrochloride, however, means that the generics cannot yet be marketed in the US because of existing patents and/or exclusivity rights. Eli Lilly’s patents on Cymbalta expire in June 2013.

Sun Pharma, which started out with just five products is now one of the leading pharma companies in India, and is increasing its presence as a global generics manufacturer.

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