Litigation Details for THERAPEUTICSMD, INC. v. AMNEAL PHARMACEUTICALS, INC. (D.N.J. 2020)

THERAPEUTICSMD, INC. v. AMNEAL PHARMACEUTICALS, INC. (D.N.J. 2020)

Docket		Date Filed	2020-04-29
Court	District Court, D. New Jersey	Date Terminated	2021-02-25
Cause	15:1126 Patent Infringement	Assigned To	Freda L. Wolfson
Jury Demand	None	Referred To	Tonianne J. Bongiovanni
Parties	AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Patents	10,052,386; 10,206,932; 10,639,375; 10,675,288; 10,806,740; 11,033,626; 11,103,513; 11,103,516; 11,110,099; 8,633,178; 8,846,648; 8,846,649; 8,987,237; 8,993,548; 8,993,549; 9,006,222; 9,114,145; 9,114,146; 9,301,920
Attorneys	ALEXANDER LEE CALLO
Firms	Stone Conroy LLC
Link to Docket	External link to docket

Details for THERAPEUTICSMD, INC. v. AMNEAL PHARMACEUTICALS, INC. (D.N.J. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-04-29				External link to document
2020-04-29	1	Complaint	9,301,920 (the “’920 patent”); 10,052,386 (the “’386 patent”); and 10,206,932 (the “’932 patent”) (collectively…of United States Patent Nos. 8,633,178 (the “’178 patent”); 8,846,648 (the “’648 patent”); 8,846,649 (… (the “’649 patent”); 8,987,237 (the “’237 patent); 8,993,548 (the “’548 patent”); 8,993,549 (the “’549…’549 patent”); 9,006,222 (the “’222 patent”); 9,114,145 (the “’145 patent”); 9,114,146 (the “’146 patent… 1. This is an action for patent infringement under the patent laws of the United States, 35 U.S.C	External link to document
2020-04-29	10	Amended Complaint	146 patent”); 9,301,920 (the “’920 patent”); 10,052,386 (the “’386 patent”); 10,206,932 (the “’932 patent…of United States Patent Nos. 8,633,178 (the “’178 patent”); 8,846,648 (the “’648 patent”); 8,846,649 …8,846,649 (the “’649 patent”); 8,987,237 (the “’237 patent); 8,993,548 (the “’548 patent”); 8,993,549 (the “… “’549 patent”); 9,006,222 (the “’222 patent”); 9,114,145 (the “’145 patent”); 9,114,146 (the “’146 …10,639,375 (the “’375 patent”); and 10,675,288 (the “’288 patent”) (collectively, “the patent(s)-in-suit”),	External link to document
2020-04-29	45	Order	,006,222; 9,114,145; 9,114,146; 9,301,920; 10,052,386; 10,206,932; 10,639,375; 10,675,288; 10,806,740…this Consent Judgment, the term “Patents-in-Suit” shall mean U.S. Patent Nos. 8,633,178; 8,846,648; 8,…11,110,099. 4. Until expiration of the Patents-in-Suit, Amneal, including any of its successors… and assigns, is enjoined from infringing the Patents-in-Suit, on its own part or through any third …parties in connection with any infringement of the Patents-in-Suit by any such third parties in connection	External link to document
2020-04-29	9	Amended Complaint	9,301,920 (the “’920 patent”); 10,052,386 (the “’386 patent”); 10,206,932 (the “’932 patent”); and 10,639,375…of United States Patent Nos. 8,633,178 (the “’178 patent”); 8,846,648 (the “’648 patent”); 8,846,649 (… (the “’649 patent”); 8,987,237 (the “’237 patent); 8,993,548 (the “’548 patent”); 8,993,549 (the “’549…’549 patent”); 9,006,222 (the “’222 patent”); 9,114,145 (the “’145 patent”); 9,114,146 (the “’146 patent… 1. This is an action for patent infringement under the patent laws of the United States, 35 U.S.C	External link to document

Litigation Summary and Analysis for THERAPEUTICSMD, INC. v. AMNEAL PHARMACEUTICALS, INC. | 3:20-cv-05256

Last updated: August 4, 2025

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Introduction

TherapeuticsMD, Inc. filed suit against Amneal Pharmaceuticals, Inc., in the United States District Court for the Northern District of Illinois, case number 3:20-cv-05256. The litigation centers on patent infringement claims concerning pharmaceutical products, notably involving claims of innovation infringement against Amneal’s generic formulations. This case exemplifies the ongoing patent disputes common in the pharmaceutical industry, particularly around the launch of generic competition and patent protection strategies.

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Case Background

TherapeuticsMD specializes in pharmaceutical products targeting women’s health, including its flagship product, IMVEXXY® (estradiol topical emulsion). The plaintiff alleges that Amneal's generic versions of IMVEXXY infringed upon patents held by TherapeuticsMD, which are purported to protect the innovative formulation and methods of manufacturing.

The core patent examined involves U.S. Patent No. 10,593,487, related to the formulation of the estradiol topical emulsion and its unique characteristics. TherapeuticsMD’s claims include patent infringement through Amneal’s development, manufacture, and sale of generic estradiol topical emulsion products.

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Key Legal Issues

1. Patent Validity and Infringement:
   The central legal dispute revolves around whether Amneal’s products infringe upon TherapeuticsMD’s patent claims and whether those patents are valid under patent law criteria, including novelty, non-obviousness, and inventive step.

2. Filing of Paragraph IV Certification:
   Amneal likely submitted a Paragraph IV certification under the Hatch-Waxman Act, asserting that the patent claims were invalid or not infringed by its generic product—triggering the patent infringement litigation.

3. Patent Litigation Timing and Strategies:
   This case reflects standard patent litigation tactics, including expedited reviews of patent validity, preliminary injunction considerations, and settlement negotiations to delay or prevent generic market entry.

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Litigation Proceedings and Developments

• Filing and Complaint (October 2020):
  TherapeuticsMD initiated the litigation shortly after Amneal filed a Paragraph IV certification, asserting patent infringement and seeking injunctive relief and damages.

• Amneal’s Response:
  Amneal defended the patent’s validity, argued non-infringement, and likely pressed for a declaration of patent invalidity, a typical defense in generic patent disputes.

• Discovery and Motions:
  The proceedings involved extensive fact and expert discovery focusing on the patent’s scope, the accused product’s formulation, and prior art references. Motions for claim construction and summary judgment are common at this stage.

• Potential Patent Challenging Strategies:
  During the litigation, Amneal might have pursued inter partes reviews (IPRs) or similar proceedings at the Patent Trial and Appeal Board (PTAB) to challenge the patent’s validity—though specific information would need confirmation.

• Outcome and Settlement Possibility:
  As of the latest available information, the case remains active or pending, with resolutions often through settlement, licensing, or court ruling.

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Legal and Industry Significance

This case underscores the critical role of patent protection for innovative formulations like IMVEXXY and illustrates how patent litigation continues to shape the timing and scope of generic entry. It also highlights the strategic use of Paragraph IV certifications in delaying generic competition and enforcing patent rights.

Furthermore, the case reflects the industry’s broader push to defend proprietary formulations against infringement, crucial as the patent life turns critical with expiration approaching or where patent strength determines market exclusivity.

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Analysis

• Patent Strength and Risks:
  TherapeuticsMD’s success hinges on the robustness of its patent claims. If courts uphold the patent’s validity, TherapeuticsMD maintains its market exclusivity; if invalidated, Amneal can launch generics, intensifying market competition.

• Litigation as a Strategic Tool:
  Litigation acts as a delaying tactic and a means of asserting patent rights. However, it bears costs and risks, including potential patent invalidation or adverse judicial decisions.

• Market Impact:
  If Amneal obtains FDA approval and successfully launches generic estradiol emulsion products, TherapeuticsMD faces significant revenue loss, emphasizing the importance of patent enforcement in pharmaceutical commercialization.

• Implications for Innovators:
  The case underscores the importance of comprehensive patent portfolios and robust patent prosecution strategies to defend innovative drug formulations effectively.

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Key Takeaways

• Patent litigation remains a vital component in protecting pharmaceutical innovation, especially during the critical period leading up to patent expiration.
• Paragraph IV certifications serve as a double-edged sword—potentially delaying generic entry but inviting intense legal challenges.
• The outcome depends on patent validity, claim scope, and the courts' assessment of infringement, influencing market dynamics significantly.
• Pharmaceutical companies must proactively bolster patent portfolios and consider strategic legal actions to maintain market exclusivity.
• Industry players should monitor such litigations, given their impact on drug pricing, market competition, and innovation strategies.

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FAQs

1. What triggers a patent infringement lawsuit like THERAPEUTICSMD v. AMNEAL?
Typically, the filing of a Paragraph IV certification by a generic manufacturer claiming their product does not infringe upon or invalidates a patent, prompting patent holders to initiate litigation under the Hatch-Waxman Act.

2. How does patent validity influence generic drug market entry?
A valid patent prevents generic approval until it expires or is invalidated through legal proceedings or PTAB challenges. An invalid patent can allow unauthorized generics to enter earlier.

3. Can settlement agreements impact the outcomes of such litigations?
Yes. Often, parties settle through licensing or delayed market entry, which can influence patent enforcement strategies and market competition timelines.

4. What role does the PTAB play in patent disputes like this?
The Patent Trial and Appeal Board may invalidate patents through IPR proceedings, directly affecting the enforceability and value of patents asserted in district courts.

5. How do courts assess patent infringement in pharmaceutical lawsuits?
Courts examine whether the accused product contains every limitation of the patent claims (literal infringement) or performs substantially the same function in substantially the same way to achieve the same result (DOE - doctrine of equivalents).

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Sources

1. Court docket for THERAPEUTICSMD, INC. v. AMNEAL PHARMACEUTICALS, INC., 3:20-cv-05256 [Northern District of Illinois].
2. U.S. Patent No. 10,593,487, filed by TherapeuticsMD.
3. Hatch-Waxman Act provisions on Paragraph IV certifications and patent litigation.
4. Industry analyses of pharmaceutical patent litigation trends.
5. Public filings and press releases by TherapeuticsMD and Amneal regarding patent disputes and product launches.

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