Litigation Details for Adare Pharmaceuticals, Inc. v. Apotex Inc. (D. Del. 2014)

Adare Pharmaceuticals, Inc. v. Apotex Inc. (D. Del. 2014)

Docket		Date Filed	2014-08-11
Court	District Court, D. Delaware	Date Terminated	2018-09-11
Cause	35:271 Patent Infringement	Assigned To	Mitchell S. Goldberg
Jury Demand	None	Referred To	Sherry R. Fallon
Parties	APTALIS PHARMATECH INC.
Patents	7,387,793; 7,790,199; 7,829,121; 9,375,410
Attorneys	Karen M. Cassidy
Firms	Phillips, McLaughlin & Hall, P.A.
Link to Docket	External link to docket

Details for Adare Pharmaceuticals, Inc. v. Apotex Inc. (D. Del. 2014)

Date Filed	Document No.	Description	Snippet	Link To Document
2014-08-11				External link to document

Litigation summary and analysis for: Adare Pharmaceuticals, Inc. v. Apotex Inc. (D. Del. 2014)

Last updated: July 29, 2026

Adare Pharmaceuticals v. Apotex (1:14-cv-01038) litigation summary and patent infringement analysis

Adare Pharmaceuticals, Inc. v. Apotex Inc., No. 1:14-cv-01038 (D. Del.), is a US Hatch-Waxman patent infringement dispute tied to Apotex’s Abbreviated New Drug Application (ANDA) for a generic version of an Adare-branded product. The case centers on Orange Book-listed patents and turns on infringement and validity arguments commonly raised in Paragraph IV litigation, with the court’s rulings tracking whether Adare’s asserted claims cover the accused Apotex drug’s active ingredient, formulation, and/or labeled method(s) of use.

What the docket posture indicates: the matter is a federal, patent-infringement action under 35 U.S.C. § 271(e)(2). The claims asserted are the Orange Book patents listed for the reference listed drug at the time of the ANDA certification, and the litigation analysis is therefore framed around claim construction, infringement proof for the ANDA product, and validity challenges (including anticipation, obviousness, indefiniteness, and non-infringement defenses).

What to take away for business decisions: the procedural posture and outcome determine (i) whether Apotex obtained a launch at risk or after an injunction/settlement, (ii) which specific asserted patents remain enforceable for follow-on exclusivity (including formulation and method-of-use estates), and (iii) whether the litigation informs the strength of Adare’s patent claims in the relevant therapeutic and delivery modality.

No reliable, complete docket and merits record is provided in the prompt, so a complete infringement/validity analysis with case-specific holdings (asserted patent numbers, claim construction outcomes, injunction/settlement terms, and final disposition dates) cannot be produced accurately.