Following its spat with Taro, over a failed merger, Sun is set to face some anxiety over its plans to launch the generic version of US pharma giant Wyeth’s $2.4 billion.
Osmotica files citizen’s petition; may have an opportunity cost
MUMBAI: Sun Pharmaceuticals seems to be getting into one trouble spot after another.
Following its spat with Taro, the Israeli pharma major, over a failed merger, Sun is set to face some anxiety over its plans to launch the generic version of US pharma giant Wyeth’s $2.4 billion anti-depression and anxiety disorder drug Effexor XR.
US-based Osmotica Pharmaceuticals, which has received the US Food and Drug Administration (FDA) approval for marketing generic Effexor, has filed a citizen’s petition requesting the FDA to ask all subsequent filers for tablet versions to re-submit their abbreviated new drug applications (ANDA) applications proving bioequivalence to Osmotica’s product as the reference listed drug (RLD).
Sun is awaiting “non-AB rating” approval (certifying that its product is non-identical to others) for marketing Effexor tablets in the US and had filed the ANDA last year. The approval is expected anytime this year after the patent expired on June 13, 2008.
The company has also received a “will not sue” covenant from innovator Wyeth and had announced that it will launch Effexor XR as soon as it gets regulatory approval.
The petition from Osmotica could, however, spoil the game for Sun.
Although the company feels Osmotica’s move is to delay its launch, Sun expects the problem will be resolved.
“Since there has been no indication from the FDA for a specific date for approvals, we cannot say that the delay is because of the petition,” a company spokesperson told DNA Money.
The spokesperson added that now it’s the FDA which has to move and right now Sun needs to wait and see.
However, analysts are keeping fingers crossed because, even as the FDA looks into the petition, it could delay Sun’s entry in the market, translating into a loss in opportunity and therefore negative financial impact on its books.
Vihari Purushothaman and Rohita Sharma of Enam Securities said in a note the opportunity for Effexor may also be lost if Sun seeks legal intervention, as ANDAs for generic Effexor-XR capsules may be approved and launched in the interim.
Sun did not disclose its revenue targets and marketing strategies for Effexor, which is thought to be a $2.4 billion opportunity.
However, the company had earlier told analysts during the annual results that it expects a gradual pick-up of sales and continue to explore avenues such as mail order or PBM to promote the generic Effexor XR equivalent.
“Since there are no precedents for a non-AB rated product of this size and magnitude, it is difficult to state a target market share number, but in our opinion it would likely be a slow and steady increase,” Dilip Shangvi, chairman and managing director of Sun, had said during the analyst conference call.
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