The Hindu Business Line : An Indian twist to Pfizer's blockbuster epilepsy drug

Multinational generic companies, such as Teva and Alpharma, have already launched their version of the same drug in the US. And Pfizer on its part is currently fighting a patent infringement case against generic manufacturers making the same drug.

Litigation notwithstanding, Indian drug companies too sniffed an opportunity in the epilepsy drug that has annual revenues in excess of $2 billion. And they too lined up supplies of gabapentin (the active ingredient in Neurontin) for sale in the US market.

But the pitch got queered recently with a notice reportedly received by Indian bulk drug company Hikal, which has just commenced gabapentin exports to the US.

When contacted by Business Line, a top-executive with Hikal was unwilling to comment on the development. Pfizer officials in India too were unwilling to comment on developments in the US market. However, an analyst following the developments said that the notice could be from either the innovator company Pfizer or competitor Teva, an Israeli generic company. Teva had launched its version of gabapentin in the US late last year.

Hikal got involved since it is part of the larger generic battle being fought over gabapentin, the analyst said. Hikal is an important link in the chain, since its bulk ingredient supplies will be used by a formulations company to make the final epilepsy medicine.

Pfizer is the patent-holder of this blockbuster drug. Nevertheless, a host of generic companies, including Apotex, Eon, Ivax and Teva, are making or are interested in making similar versions of the same medicine, the analyst said. It could be in Pfizer's interest to prevent generic companies from operating in the same segment by targeting bulk drug suppliers, the analyst observed.

A similar explanation would be valid for Teva too, as the generic drug manufacturer contends with competition on the same drug, he added.

A final judgment on the patent litigation filed by Pfizer in 1998 is still pending. Meanwhile, generic companies launched gabapentin in the US on a "launch at risk" basis, that is, assuming that the US court will rule in favour of the generic companies, thereby allowing the launch of gabapentin clones. And as legal claims and counter-claims are made over the drug, Pfizer recently got a shot-in-the-arm with a US court allowing "authorised generics". The judgment was in response to Teva's suit against the introduction of authorised generics of the drug by Pfizer (Pfizer authorises another company to produce a generic version of the same drug).

Innovator companies have authorised generics to blunt the sales of competing companies in the same segment. The presence of a generic drug authorised by the innovator company also makes the market unattractive for other generic competitors looking to make a killing from making clones of the blockbuster drug.

The authorised generics ruling comes as a dampener for Indian generic companies looking at the US and not just the ones looking to be part of the gabapentin story, an analyst said.

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An Indian twist to Pfizer's blockbuster epilepsy drug