Under the settlement agreement, InnoPharma can start selling a generic version of the eye drug in the United States from Feb 24, 2024 or earlier under certain circumstances. Moreover, under certain circumstances, InnoPharma will be allowed to launch an authorized generic version of Restasis on Aug 28, 2024.
Allergan is adopting different ways of protecting Restasis from generic competition. The company recently came under fire for entering into an agreement with the Saint Regis Mohawk Tribe, with lawmakers questioning the unconventional move adopted by the company to protect the blockbuster eye drug from generic competition. Restasis is Allergan’s second best-selling drug bringing in sales of almost $1.5 billion in 2016. Lawmakers pointed out that the sovereign status of Native American tribes would make any patent challenges lengthy and complex as tribes may be immune from the legal claims made by generic drug makers to challenge patents. In fact, the Tribe is filing to dismiss the ongoing inter partes review (“IPR”) of the Restasis patents based on their sovereign immunity from IPR challenges.
The deal with the Tribe has basically raised concerns that it will curb generic competition in the pharmaceutical industry and discourage generic drugmakers from making cheaper copy-cat versions of expensive drugs. Allergan has been asked by the Committee on Oversight and Government Reform to provide certain documents and information about the deal by Oct 17, 2017.
Merck Will Not File Anacetrapib:
Merck Will Not File Anacetrapib:Merck has decided that it will not seek regulatory approval for its investigational CETP inhibitor, anacetrapib. The company’s decision was based on a thorough review of the clinical profile of the drug. We note that Merck is not the first company to drop a CETP inhibitor from its plans. Companies like Lilly, Roche and Pfizer have all had high profile setbacks with their CETP inhibitors and the class was more or less written off (Read more: Merck Will Not Seek Approval for CETP Inhibitor Anacetrapib).
CRL for AcelRx’s Dsuvia:
CRL for AcelRx’s Dsuvia:AcelRx Pharmaceuticals’s ACRX shares plunged 59.8% with the company getting a Complete Response Letter (“CRL”) from the FDA for Dsuvia (sufentanil sublingual tablet). The FDA said that it cannot approve the regulatory application in its current form and has asked for additional safety data. The agency has also asked the company to make certain changes to the Directions for Use to ensure the proper administration of the tablet. AcelRx has been asked to validate the same through a human factors study. AcelRx is looking to get Dsuvia approved for the reduction of moderate-to-severe acute pain and dosing errors associated with IV administration via its non-invasive single-dose applicator (“SDA”) in medically supervised settings.
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