New Delhi, Aug. 26: Ranbaxy Pharmaceuticals Inc (RPI), the wholly-owned US subsidiary of Ranbaxy Laboratories Limited (RLL), has received the US regulatory authority’s approval to make and market the generic version of Terazosin Hydrochloride capsules. The drug, used to treat patients with prostate problems, notched up sales of $ 206.8 million last year in the US.
The innovator of this drug is Abbott Laboratories, which makes this drug under the brand name Hytrin. The sales figure for the drug in the US last year includes that of Hytrin and five other generic players.
The final nod from US Food and Drug Administration (USFDA) has been granted for capsules of 1 mg, 2 mg, 5 mg and 10 mg formulations and the drug has been deemed as bio-equivalent and therapeutically equivalent of Hytrin capsules manufactured by Abbott Laboratories.
Ranbaxy plans to make the product available for marketing and distribution through the RPI commercial teams within the next 30-45 days for all classes of trade-including wholesalers, chain pharmacies and generic distributors that support the dispensing and therapeutic usage of this product. However the company refused to spell out the kind of market share it estimates from the drug.
“The product represents yet another addition to the expanding portfolio that consists not only of solid dosage forms but now includes an increasing number of value added dosage forms,” president and CEO Dipak Chattaraj said.
A company spokesperson added: while the generic competitors make this product as a hard gelatine capsule, Ranbaxy and one other company are the only two to do so in soft gelatine capsules identical to the innovator.
It will be manufactured at RLL’s facility at Paonta Sahib in Himachal Pradesh.