News & Analysis as of

Hatch-Waxman Abbreviated New Drug Application (ANDA) Manufacturers

Robins Kaplan LLP

Generic Launches - Winter 2024

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This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more

Array

eDiscovery and ANDA Litigation: Unique Timelines, Processes, and Workflows

Array on

ANDA litigation is a high-stakes niche of pharmaceutical law that presents unique challenges not only for lawyers, but also for eDiscovery practitioners. Here’s why: under the Drug Price Competition and Patent Term...more

Robins Kaplan LLP

Challenging Drug Patents: Does AIDS Healthcare Raise an “Actual Controversy”?

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Manufacturers who want to introduce generic drugs face a special delay and enjoy a corresponding special right to challenge patents on branded drugs based on the great compromise in the Hatch-Waxman Act. ...more

McDonnell Boehnen Hulbert & Berghoff LLP

In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation (Fed. Cir. 2013)

On the first day of February, the Federal Circuit rejected Impax's efforts to get out from under a preliminary injunction in a case captioned In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation. ...more

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