24 September 2013Americas

Ranbaxy receives notice for acne drug generic

Drug company Watson Laboratories (Actavis) has notified rival Ranbaxy Laboratories that it has applied to sell a generic version of anti-acne product Absorica in the US.

Indian company Ranbaxy, which has a subsidiary in the US, licenses the drug (isotretinoin capsules) from Cipher Pharmaceuticals.

Absorica was approved by the US Food and Drug Administration (FDA) in May 2012 and granted a three-year period of market exclusivity, which expires in May 2015. Two patents covering the drug expire in 2021.

Before the Paragraph IV Certification Notice was sent to Ranbaxy on September 19, Watson filed an abbreviated new drug application (ANDA) with the FDA.

Ranbaxy and Cipher “intend to vigorously defend Absorica’s intellectual property rights and pursue all available legal and regulatory pathways in defence of the product”, the company said in a statement.

“RLI [Ranbaxy] shall take appropriate actions in response to the Paragraph IV notice letter, and FDA approval of the ANDA shall then be governed by the Hatch-Waxman Act.

Watson did not respond to a request for comment.

After an ANDA has been filed, pharma companies have 45 days to file suit against the generic applicant. If legal action is taken, the FDA cannot approve the ANDA until either the generic wins the suit or 30 months elapses, whichever comes first.

Andrew Williams, partner at McDonnell Boehnen Hulbert & Berghoff LLP, said he would be surprised if Ranbaxy and Cipher did not take legal action.

Absorica is used to treat severe recalcitrant nodular acne in patients 12 years and above. As of August 2013, its revenue in the US and Canada was $6.2 million.

Williams noted that Hoffman La Roche used to sell the isotretinoin compound “years ago” but that the company is no longer in the market. The product sold by Ranbaxy is reformulated from that compound, he said, and offers a higher level of absorption.

“The investment (by Ranbaxy) was presumably less than Hoffman’s – as reformulating a drug is generally a lot cheaper,” Williams said.

Ranbaxy and Watson are both considered generic companies, he said, but with generic companies filing more drug applications and pharma companies applying for more generic  drugs, “the lines are becoming blurred”.

According to Cipher, 20 million Americans have acne severe enough to cause scarring.

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