Teva Sues US FDA To Obtain 180-Day Exclusivity For Its Generic Restasis
Complaint challenges agency's revised definition of "first applicant," which does not require notice of Paragraph IV certification to obtain exclusivity.
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In one of the most keenly-watched markets, Viatris has emerged as the winner of approval for the first US generic version of AbbVie’s Restasis 0.05% ophthalmic emulsion, years after its IP was taken down. Numerous firms and analysts had acknowledged the complexity of the reference brand.
Agency reinterprets definition of "first applicant" and applies "failure to market" forfeiture provision of MMA; court halts sales of Dr. Reddy's generic.
Restasis Patent Review Back On Track As Federal Circuit Quashes Mohawk Tribe's Sovereign Immunity Claim
Appeals court says inter partes review is more like an agency enforcement action than a civil suit and thus tribal immunity does not apply to the proceeding; PTAB now to determine patentability of Restasis patents.