Last updated: June 17, 2026
Executive summary
The litigation captioned Assertio Therapeutics, Inc. v. Patrin Pharma, Inc. (1:20-cv-05055) centers on U.S. patent infringement related to FDA-regulated drug approval, with Assertio as plaintiff and Patrin as the accused generic or generic applicant. The docket indicates active district-court proceedings beginning in 2020, with outcomes likely driving market entry timing and scope of patent protection (Orange Book, asserted patents, and any settlement terms).
No docket-specific filings, asserted patents, claim construction, Markman outcomes, trial dates, or settlement terms are provided in the prompt, so a complete litigation summary cannot be produced without fabricating case facts.
What is Assertio Therapeutics v. Patrin Pharma (1:20-cv-05055) about?
Answer: The case is a district-court patent dispute filed by Assertio Therapeutics, Inc. against Patrin Pharma, Inc. under U.S. patent law and tied to FDA-regulated commercialization.
Who are the parties and what is the procedural posture?
- Plaintiff: Assertio Therapeutics, Inc.
- Defendant: Patrin Pharma, Inc.
- Court/Case number: U.S. District Court, 1:20-cv-05055 (filed in 2020)
What patents were asserted in Assertio v. Patrin Pharma (1:20-cv-05055)?
Answer: Not determinable from the information provided.
How to identify the asserted patents from the docket
A litigation analysis normally requires:
- Complaint or Amended Complaint listing U.S. patent numbers
- Any claim list per asserted patent
- Whether the case is styled as a Hatch-Waxman paragraph IV dispute, and which Orange Book-listed drug is implicated
No complaint text or patent list is included in the prompt.
Which FDA product and Orange Book listing does the case target?
Answer: Not determinable from the information provided.
Why Orange Book mapping is required for a real infringement summary
A correct analysis requires linking:
- The Assertio drug product (NDA/ANDA, strength, dosage form)
- The Orange Book patents (drug substance, formulation, method-of-use, or manufacturing)
- The Paragraph IV certification driving the litigation
The prompt does not include the NDA/ANDA, drug name, or Orange Book patents.
When did exclusivity or patent expiry matter for Assertio vs. Patrin Pharma?
Answer: Not determinable from the information provided.
Typical exclusivity/patent timeline components to extract
- New chemical entity or biologic exclusivity (if applicable)
- 5/3-year Hatch-Waxman exclusivity
- Orange Book “listed” patent expirations
- Any Patent Term Adjustment (PTA) and patent-specific legal expiration
The prompt contains only the case caption and docket number.
What did the court decide on preliminary injunction, TRO, or stay?
Answer: Not determinable from the information provided.
What to look for in docket events
A credible litigation summary depends on:
- Any preliminary injunction briefing
- Any stipulated stay pending PTAB or related proceedings
- Whether the court issued claim construction orders early
No orders or event history are included.
Did Assertio and Patrin reach a settlement?
Answer: Not determinable from the information provided.
Settlement terms that materially affect market entry
A settlement analysis normally covers:
- Licensed product entry date
- Design-arounds and carve-outs
- Monetary terms
- Dismissal scope and which patents were released
No settlement indicator (e.g., joint motion to dismiss, consent judgment, or public press release) is included.
How does this litigation affect generic entry risk for the Assertio product?
Answer: Not determinable from the information provided.
Generic entry depends on the specific asserted patent set
Risk is driven by whether the case targets:
- Drug substance patents (harder for generics to design around)
- Formulation or process patents
- Method-of-use patents (often tied to the label carve-out)
- Whether the defendant attempted AB-rated versus non-AB design-around
Without product identity and asserted patents, risk cannot be calculated.
What manufacturing/IP barriers would design-around strategies face?
Answer: Not determinable from the information provided.
Design-around analysis requires claims and technical scope
A meaningful barriers assessment needs:
- Claim language from asserted patents
- FDA formulation parameters (if method-of-use, label scope)
- Any claimed manufacturing steps or critical process parameters
No technical or claim information is provided.
How strong is Assertio’s patent estate in this case?
Answer: Not determinable from the information provided.
Patent strength in litigation is claim- and forum-dependent
A standard strength evaluation uses:
- Survival of motions to dismiss
- Claim construction results
- Infringement/non-infringement rulings
- PTAB outcomes for any challenged patents
No case decisions are provided.
What procedural next steps typically follow in cases like this?
Answer: Not determinable from the information provided.
Typical endgame milestones
- Joint scheduling order and discovery
- Claim construction (Markman)
- Summary judgment or trial
- Dismissal/settlement or final judgment
The docket events are not included.
Key Takeaways
- The prompt identifies the case Assertio Therapeutics, Inc. v. Patrin Pharma, Inc., 1:20-cv-05055 and the parties.
- A complete litigation summary (asserted patents, FDA product mapping, rulings, settlement, and entry timing) is not possible because the prompt does not include docket filings or case event content.
FAQs
- What is the significance of the case number 1:20-cv-05055 for retrieving the docket history?
- How do Hatch-Waxman paragraph IV certifications typically shape infringement allegations in these disputes?
- What documents in a district-court docket usually list the asserted patents first?
- How do settlement dismissals in Hatch-Waxman cases affect future generic Paragraph IV challenges?
- Which claim types (substance, formulation, method-of-use) most often survive to summary judgment?
References
- Not available from the information provided in the prompt.
