Food and Drug Administration (FDA) of the US on 6 November 2014 withdrew the previously granted tentative marketing approvals for the Ranbaxy’s anti-ulcer drug Nexium and HIV infection drug Valcyte.
With this Ranbaxy lost its six-month market exclusivity for its ANDAs (abbreviated new drug application) for Valycyte and may also lose the six-month market exclusivity for the Nexium copy in the US. This is because 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.
Why the withdrawal of approval?
The withdrawal of the approval was taken after FDA determined that Ranbaxy’s ANDAs for Nexium and Valcyte did not have any data integrity issues and its original decisions granting tentative approvals were in error because of the compliance status of the facilities at the time of tentative approvals.
Impact of the withdrawal on Ranbaxy
Withdrawal of the approvals means the revival of the Indian pharmaceuticals major Ranbaxy Laboratories Ltd in the US market has hit a roadblock.
Since 2008, Ranbaxy has been looking for revival after FDA had banned its Indian manufacturing plants Poanta Sahib in Himachal Pradesh and Mohali in Punjab from exporting to that market due to failure in manufacturing standard compliances.
Ranbaxy started showing signs of revival in past one year after the US FDA had granted approval for the launch of these two generic drugs. These approvals had also allowed a six-month exclusive marketing right for Ranbaxy, as it was the first company to seek such an approval.
Further it 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
For Ranbaxy, the Nexium generic was a 170 million US dollars sales opportunity if it could launch the drug with market exclusivity.
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 US dollars during the exclusivity period. Ranbaxy was expected to post a profit of 25 million US dollars from Valcyte launch during the exclusivity.
Ranbaxy was expected to launch its low-cost version of Nexium in May 2014, when the brand’s patent expired, but it couldn’t due to an FDA delay in giving its final approval. With this FDA came under pressure from citizens forums to speed up the launch of the low-cost version.
This intensified in the first week of November 2014 when the Attorney General 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.
When: 6 November 2014
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