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Patents Regulatory Requirements Abbreviated New Drug Application (ANDA)

Venable LLP

Potential Impact of the Affordable Prescriptions for Patients Act Patent Limit on BPCIA Litigations

Venable LLP on

On March 17, 2025, Senators Chuck Grassley (R-IA), John Cornyn (R-TX), Richard Blumenthal (D-CT), and Richard Durbin (D-IL) re-introduced the “Affordable Prescriptions for Patients Act” (“APPA”), which previously passed the...more

Robins Kaplan LLP

Novartis Pharms. Corp. v. Becerra

Robins Kaplan LLP on

Entresto® (sacubitril/valsartan) - Case Name: Novartis Pharms. Corp. v. Becerra, Civ. No. 24-cv-2234 (DLF), 2024 WL 4492072 (D.D.C. Oct. 15, 2024) (Friedrich, J.)  Drug Product and Patent(s)-in-Suit: Entresto®...more

Foley & Lardner LLP

Federal Circuit Says Proper Orange Book-Listed Patent Must Claim Active Ingredient

Foley & Lardner LLP on

In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the Federal Circuit jumped on the bandwagon of scrutinizing the types of patents that can be listed in the Food & Drug...more

McDermott Will & Emery

Transparency Is the Best Medicine: Device Parts Don’t Justify Orange Book Listing

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit affirmed a district court’s delisting of patents from the Orange Book because the patent claims did not “claim the drug that was approved” or the active ingredient of the drug...more

Polsinelli

FDA Publishes Industry Guidance Document for Amendments to Abbreviated New Drug Applications

Polsinelli on

In early July 2018, the United States Food and Drug Administration (FDA) issued a final guidance document titled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA – Guidance for Industry." A...more

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