Litigation Details for Noven Pharmaceuticals, Inc. v. Amneal Pharmaceuticals LLC (D. Del. 2018)

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Noven Pharmaceuticals, Inc. v. Amneal Pharmaceuticals LLC (D. Del. 2018)

Docket	⤷ Start Trial	Date Filed	2018-05-08
Court	District Court, D. Delaware	Date Terminated	2020-09-11
Cause	35:271 Patent Infringement	Assigned To	Leonard Philip Stark
Jury Demand	None	Referred To
Patents	6,841,716; 8,231,906; 9,724,310; 9,730,900; 9,833,419
Link to Docket	External link to docket

Small Molecule Drugs cited in Noven Pharmaceuticals, Inc. v. Amneal Pharmaceuticals LLC

The small molecule drug covered by the patents cited in this case is ⤷ Start Trial .

Details for Noven Pharmaceuticals, Inc. v. Amneal Pharmaceuticals LLC (D. Del. 2018)

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Date Filed	Document No.	Description	Snippet	Link To Document
2018-05-08				External link to document
2018-05-08	112	Opinion - Memorandum Opinion	infringement of U.S. Patent Nos. 9,730,900 (the "' 900 Patent"), 9,724,310 (the '"…quot; 310 Patent"), and 9,833 ,419 (the '" 419 Patent") (collectively, "patents-in-suit…-suit" or "asserted patents"). (D.I. 83 at 3) The patents-in-suit relate "to transdermal…; It is a bedrock principle of patent law that the claims of a patent define the invention to which the…reading the entire patent." Id. at 1321 (internal quotation marks omitted). The patent "specification	External link to document
2018-05-08	13	Patent/Trademark Report to Commissioner of Patents	the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 6,841,716 . (Wilson, Samantha… 11 September 2020 1:18-cv-00699 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2018-05-08	249	Order - -Memorandum and Order	of U.S. Patent Nos. 9,833,419 (the “419 patent”), 9,730,900 (the “’900 patent”), and 9,724,310 (the “°… infringes the °419 patent; (2) Amneal’s product does not infringe the °900 patent under the doctrine … does not infringe the ’310 patent under the DOE; (4) the asserted patents are invalid for lack of enablement…the asserted patents claimed transmucosal patches; (2) the specification of the patents contained no …notified Innovation that the ’140 patent was legally insufficient either as patent ineligible subject matter	External link to document
2018-05-08	25	Consent Judgment - Proposed	PROPOSED CONSENT JUDGMENT with respect to U.S. Patent No. 6,841,716, by Hisamitsu Pharmaceutical Co. Inc.. (… 11 September 2020 1:18-cv-00699 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2018-05-08	4	Patent/Trademark Report to Commissioner of Patents	Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,730,900 ;9,724,310 ;9,833,419. (… 11 September 2020 1:18-cv-00699 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2018-05-08	9	Patent/Trademark Report to Commissioner of Patents	the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,231,906 . (Gaza, Anne) (Entered… 11 September 2020 1:18-cv-00699 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
>Date Filed	>Document No.	>Description	>Snippet	>Link To Document

Last updated: July 29, 2026

ecutive summary: The case Noven Pharmaceuticals, Inc. v. Amneal Pharmaceuticals LLC (D. Del., No. 1:18-cv-00699) is a Hatch-Waxman patent infringement dispute in which Noven accused Amneal of infringing Orange Book-listed patents tied to Noven’s product(s) and associated FDA-approved uses. The litigation posture, asserted patent set, and any later settlements or PTAB outcomes determine the practical generic entry risk. However, the record needed to produce a complete, accurate litigation summary (asserted patents and claims, procedural milestones, court rulings, and any settlement terms) is not contained in the prompt, and a complete response cannot be generated.

What is Noven Pharmaceuticals v. Amneal Pharmaceuticals LLC (1:18-cv-00699) about?

Answer: It is a Delaware Hatch-Waxman patent infringement case brought by Noven against Amneal. The case is indexed as 1:18-cv-00699 and is commonly associated with alleged infringement tied to an FDA-approved drug’s Orange Book patent estate.

Which drug and Orange Book patents were at issue?

Answer: Not determinable from the provided input. A litigation summary requires the asserted patent numbers and the FDA product/patent linkage (Orange Book listing) that triggered the infringement claims.

What statute and theory were pled?

Answer: Hatch-Waxman patent infringement under 35 U.S.C. § 271(e)(2) and related counts are typical for these actions, but the specific counts and theories for this docket cannot be confirmed from the provided input alone.