BackRanbaxy’s US revival bid hits FDA hurdle
Regulator withdraws tentative marketing approvals for generic versions of anti-ulcer, HIV infection drugs
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Mumbai: In a development that can severely impact the revival of drug maker Ranbaxy Laboratories Ltd in the US, the Food and Drug Administration (FDA) has withdrawn a previously granted tentative marketing approval for the firm’s generic versions of anti-ulcer drug Nexium and HIV infection drug Valcyte.
“The FDA has rescinded the previously granted tentative approvals for Ranbaxy’s ANDAs (abbreviated new drug application) for esomeprazole magnesium delayed-release capsules, and for valganciclovir hydrochloride tablets," Ranbaxy informed stock exchanges on Thursday.
The Indian drug maker, which had bigger challenges in the US market since 2008 after FDA banned its Indian manufacturing plants from exporting to that market due to failure in manufacturing standard compliances, had shown signs of revival in the last one year after it could get approvals for its generic copies of some of the blockbuster brands, including Nexium and Valcyte. These approvals had also allowed a six-month exclusive marketing right for Ranbaxy, as it was the first company to seek such an approval.
Ranbaxy, which has lost almost its entire revenue from the US market after the ban, had significantly revived its earnings by the launch of its generic versions of Cypher Pharmaceutical Inc’s anti-acne drug Absorica and Novartis AG’s blood pressure drug Diovan in 2013-14.
Ranbaxy might lose the market exclusivity for Nexium and Valcyte, say analysts. “US FDA has determined that Ranbaxy’s ANDAs of concern did not have any data integrity issues, but its original decisions granting tentative approvals were in error because of the compliance status of the facilities referenced in the ANDAs at the time of tentative approvals. As a consequence, Ranbaxy has forfeited its eligibility for 180-day exclusivity for its ANDA for Valcyte," Ranbaxy said in its Thursday note to stock exchanges.
“In case Ranbaxy also loses its exclusivity on Nexium, too, then it would be a big negative, as it was expected to generate an income of at least $105 million during the exclusivity period," said Hitesh Mahida, an analyst with Antique Stock Broking Ltd, adding that the firm was expected to post a profit of $25 million from Valcyte launch during the exclusivity.
Ranbaxy was expected to launch these drugs this fiscal. “Ranbaxy is disappointed with this development and is actively evaluating all available options to preserve its rights," the company said on Thursday.
Ranbaxy may lose the six-month market exclusivity for the Nexium copy in the US, as there is pressure mounting on FDA to look at other generic applicants on account of a five-month delay in Ranbaxy’s launch of its version of Nexium, Mint had reported in September.
Ranbaxy was expected to launch its low-cost version of Nexium in May, when the brand’s patent expired, but it couldn’t due to an FDA delay in giving its final approval.
FDA has been under pressure from citizens forums to speed up the launch of the low-cost version since May. This intensified last week when the attorney general of the state of Connecticut, George Jespen, wrote to FDA seeking immediate action to either expedite Ranbaxy’s launch or approve other drug firms that have also applied for the generic launch in the US market.
For Ranbaxy, the Nexium generic was a $170 million sales opportunity if it could launch the drug with market exclusivity. But it was in a spot, having had to move the manufacturing site for this product twice in the last six years after the original sites—Poanta Sahib in Himachal Pradesh and Mohali in Punjab—came under an FDA ban.
Ranbaxy is now trying to move the product registration and manufacturing site to its US factory in New Jersey, but this has not been cleared by FDA, Mint reported in September.
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