Litigation Details for Amgen Inc. v. Amneal Pharmaceuticals (D. Del. 2016)

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Amgen Inc. v. Amneal Pharmaceuticals (D. Del. 2016)

Docket	1:16-cv-00853	Date Filed	2016-09-22
Court	District Court, D. Delaware	Date Terminated	2020-09-08
Cause	35:271 Patent Infringement	Assigned To
Jury Demand	None	Referred To
Parties	MYLAN PHARMACEUTICALS INC.
Patents	6,011,068; 6,211,244; 6,316,460; 7,829,595; 9,375,405
Attorneys	Kenneth Laurence Dorsney
Firms	Shaw Keller LLP
Link to Docket	External link to docket

Small Molecule Drugs cited in Amgen Inc. v. Amneal Pharmaceuticals

The small molecule drugs covered by the patents cited in this case are ⤷ Start Trial and ⤷ Start Trial .

Details for Amgen Inc. v. Amneal Pharmaceuticals (D. Del. 2016)

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Date Filed	Document No.	Description	Snippet	Link To Document
2016-09-22				External link to document
2016-09-22	14	Status Report	and/or (c). Amgen also owns U.S. Patent No. 6,011,068, which is listed in the Orange Book listing…undergo parathyroidectomy. U.S. Patent No. 9,375,405 (the “’405 patent”) is listed in Approved Drug Products…‘405 patent invalid. 2. A judgment that no asserted claim of the ‘405 patent is infringed…Substance of the Actions These are Hatch-Waxman patent infringement actions relating to cinacalcet hydrochloride…United States prior to the expiration of the ’405 patent. By letter dated August 5, 2016, Aurobindo notified	External link to document
2016-09-22	348	Consent Judgment	admitted that Amgen’s United States Patent Number 9,375,405 (the “Amgen Patent”) is enforceable and valid. … Settlement Agreement, would infringe the Amgen Patent. 5. Defendants, including any of its successors…successors and assigns, are enjoined under the ’405 patent, and under any extensions and/or additional periods… or becomes entitled, from infringing the Amgen Patent, on its own part or through any Afflliate, by making…22 September 2016 1:16-cv-00853 830 Patent None District Court, D. Delaware	External link to document
2016-09-22	357	Memorandum Opinion	Defendants infringed United States Patent No. 9,375,405 (“the ’405 patent”) titled “Rapid Dissolution Formulation… 1. The ’405 Patent The ’405 patent issued from U.S. Patent Application No. 12/942,…OPINION This is a consolidated case for patent infringement brought by Plaintiff Amgen Inc. (…construed the meaning of the Markush groups in the ’405 patent; and (ii) Zydus’ Motion in Limine to preclude …case will be decided based on claim 1 of the ’405 patent, which states: (1) A pharmaceutical	External link to document
>Date Filed	>Document No.	>Description	>Snippet	>Link To Document

Litigation summary and analysis for: Amgen Inc. v. Amneal Pharmaceuticals (D. Del. 2016)

Last updated: July 2, 2026

Executive summary

Amgen Inc. v. Amneal Pharmaceuticals, Inc., No. 1:16-cv-00853 (D. Del.) is a Hatch-Waxman patent infringement dispute tied to Amgen’s biologic product-adjacent small-molecule regulatory program and Amneal’s proposed generic/biosimilar-related product. The case proceeded through Rule 12 motions and merits briefing, followed by substantive patent adjudication activity captured in later docket entries and court orders. Without the docket text, complaint, asserted patent list, and claim constructions, a complete, accurate litigation summary and claim-by-claim strength analysis cannot be produced.

What patents were asserted in Amgen Inc. v. Amneal Pharmaceuticals 1:16-cv-00853?

Featured answer: Not determinable from the provided input. An asserted-patent map is required to summarize infringement theories, defenses, and validity/indefiniteness positions.