Although the API supply agreement between the Mumbai-based Hikal Limited and the US-based Torpharm Inc, an arm of Canadian generics major Apotex Inc, was signed in 2002, the actual supply is likely to be delayed at least by a year.
Though Hikal was supposed to send the consignments of Gabapentin, an anti depressant, to Torpharm soon after the formal agreement, the market sources say that due to the eventual extension in the original patent expiry of the drug, which is with Pfizer at present, and the further six month market exclusivity granted to Aai Pharma in the US, the company's export would start only by the end of 2004, after three years of the pact.
As per the agreement, the custom-manufacturing firm Hikal would be supplying APIs such as Gabapentin, which will be manufactured at Hikal's API plant at Bangalore. Starting with Gabapentin, the company would also supply APIs like Bupropion HCL and Pentoxyfillin, said sources. The market for Gabapentin is worth $2 billion in US.
Aai Pharma is expected to begin its supply, within the next few months, sources maintain. Gabapentin patent expired in April 2002. However, on account of a series of legal battles between the original patent holder Pfizer and Aai Pharma over patent infringement the opening of Gabapentin into the generics world got delayed. It was only in a recent hearing that the issue was resolved thereby giving Aai Pharma the green signal for launch.
When contacted Hikal officials refused to either confirm or deny the news. The company officials had earlier mentioned signing a contract to supply APIs to "a large generics company" in the US. However on account of the secrecy agreement with the US company, they were reluctant to disclose the partner's name.
Hikal's Bangalore facility is ISO 9001, WHO GMP and TGA (Australia)-compliant and is now awaiting United States Food and Drug Administration (USFDA) inspection.
A predominantly agrochemicals maker, Hikal recently increased its expansion in pharmaceuticals hoping to grab generic drug export opportunities in the US market. Its range of products includes Acebutolol HCI, Bupropion HCI, Buzepide, Methiodide, Cinnarizine, Clocinizine Dihydrochloride, Flunarizine HCI and Gabapentin, among others.
Gabapentin is an anti-depressant and the generic equivalent of Neurontin brand tablets and capsules, a Pfizer product. Neurontin has reported sales of over $2 billion and is also used in the treatment of partial seizures of epilepsy and post-herpetic neuralgia.