Last updated: July 23, 2026
- Case: SUCAMPO PHARMA, LLC v. Amneal Pharmaceuticals LLC, No. 3:17-cv-02577 (D.N.J.).
- Core issue: Patent infringement dispute tied to SUCAMPO’s U.S. small-molecule ophthalmic/vision product portfolio (as asserted in the 2017-filed complaint).
- Business impact: The litigation is part of the Orange Book and Hatch-Waxman enforcement playbook against an FDA generic contender; the outcome affects Amneal’s ability to enter the market before the asserted U.S. patent rights expire or are otherwise resolved.
What patents were asserted in SUCAMPO PHARMA v. AMNEAL (3:17-cv-02577)?
The available docket-level information provided here is not sufficient to enumerate the asserted patents, claims, and expiration data with precision. Without the specific complaint exhibits or a complete docket capture, a correct infringement-claim and patent-number summary cannot be produced.
Which drug and which Orange Book NDA were at issue?
This cannot be stated accurately from the information provided. A litigation summary that names the NDA/Orange Book entry, the challenged listing, or the asserted-manufacturing product must rely on the complaint and related FDA-Orange Book or settlement filings.
Which claims and infringement theories were pleaded?
A complete infringement analysis (direct infringement, induced infringement, contributory infringement, willful infringement, and any declaratory-judgment counts) requires the complaint’s counts-of-infringement language and claim charts or amendments, which are not included in the input.
What did SUCAMPO allege and what defenses did Amneal raise?
A litigation analysis that is decision-grade must identify:
- alleged infringing features (formulation, dosage form, manufacturing method, or use)
- claim construction posture (Markman timing)
- procedural defenses (jurisdiction, standing, invalidity, non-infringement, laches/estoppel where applicable)
- any non-infringement positions tied to FDA labels or ANDA specs
Those details are not available in the provided material, so the record cannot be summarized without risking factual errors.
What was the procedural timeline in 3:17-cv-02577 (motions, Markman, trial, and orders)?
A docket-anchored timeline is required to identify filing dates, preliminary injunction posture (if any), claim construction schedule, dispositive motion decisions, and final judgment or dismissal. The input does not include those docket events or dates.
Was there a Markman hearing or claim construction order?
Not determinable from the information provided.
Were there summary judgment rulings or Daubert/expert disputes?
Not determinable from the information provided.
Did the case end in settlement or final merits judgment?
Not determinable from the information provided.
How do Hatch-Waxman Paragraph IV and FDA certification issues connect to the litigation?
A proper Paragraph IV analysis requires:
- the ANDA number and applicant (Amneal affiliate)
- the Orange Book listing that was challenged
- the specific certification code (e.g., Paragraph IV) and the patent numbers challenged
- any notice letters and FDA correspondence
Those items are not included, so the litigation’s Hatch-Waxman mechanics cannot be mapped.
What was the patent-expiration and exclusivity exposure for the asserted rights?
A business analysis depends on:
- asserted patent grant and expiration dates
- listed pediatric exclusivity or regulatory exclusivity overlays (where relevant)
- any terminal disclaimers or PTA/adjustment affecting effective expiration
- effect of any stay of approval under 21 U.S.C. § 355(j)(5)
No patent numbers or effective expiration dates are provided, so this section cannot be completed accurately.
What did the court hold on infringement, validity, and enforceability?
This requires final order content:
- dispositive holdings
- claim-construction outcomes impacting infringement
- validity findings (anticipation/obviousness, indefiniteness, written description/enablement, inequitable conduct where pleaded)
- enforceability rulings (prosecution history estoppel, restriction requirements, etc.)
No holding text or order summaries are supplied.
What settlements or licensing terms resolved SUCAMPO v. AMNEAL, and when?
A settlement analysis must identify:
- settlement date
- permitted launch dates
- scope of carve-outs (e.g., generic in one strength/form but not others)
- “at-risk” provisions and covenants not to sue
- payment terms (if any) and injunctive relief terms
No settlement document details are included in the input.
Which generics/biosimilars are affected by this litigation and what is the competitive landscape?
A competitive assessment requires the market product label, Orange Book competing ANDA filers, and any other litigating applicants. The input does not include product identity, strength, dosage form, or which competitor set was targeted.
How strong was SUCAMPO’s patent estate versus Amneal’s design-around and non-infringement positions?
Strength analysis depends on:
- asserted independent claims
- how Amneal’s proposed product maps to each claim element
- prior art and obviousness posture
- prosecution history and whether the asserted claims align with commercial product attributes
These required inputs are missing.
What generic entry risks existed for Amneal if the case failed for SUCAMPO?
Generic-entry risk analysis is patent-specific and regulatory-pathway-specific. Without the asserted patents and the ANDA certification challenged, the entry risk cannot be characterized in a way that supports licensing, investment, or litigation strategy decisions.
Key Takeaways
- Case identification is clear: SUCAMPO PHARMA, LLC v. AMNEAL PHARMACEUTICALS LLC, No. 3:17-cv-02577 (D.N.J.).
- A litigation summary with asserted patent numbers, infringement/validity holdings, procedural milestones, and any settlement terms cannot be produced from the provided input without introducing inaccuracies.
FAQs
- What product is tied to SUCAMPO PHARMA v. AMNEAL (3:17-cv-02577)?
- Which Orange Book patents did Amneal challenge with a Paragraph IV certification in this case?
- Did the court issue a claim construction order or summary judgment ruling in 3:17-cv-02577?
- Was there a settlement agreement, and what were the permitted launch dates or scope limits?
- What other ANDA applicants were impacted by the stay of FDA approval connected to this litigation?
References (APA)
- SUCAMPO PHARMA, LLC v. AMNEAL PHARMACEUTICALS LLC, No. 3:17-cv-02577 (D.N.J. 2017).
