Last updated: July 27, 2026
ACRAFSpA and Aziende Chimiche Riunite Angelini Francesco ACRAFSpA v. Aurobindo Pharma USA Inc. (1:19-cv-02197) is a Hatch-Waxman patent dispute filed in 2019 in the US District Court for the District of New Jersey. The case is a Paragraph IV type challenge tied to Aurobindo’s ANDA and is typically resolved through a settlement and licensing framework that governs generic launch timing. The case record as provided here is insufficient to identify the asserted patents, the Orange Book-listed reference product, the specific ANDA product, the district court claim construction record, and whether any appellate outcome occurred.
No complete, accurate litigation summary can be produced without the docket’s substantive filings (complaint, answer, infringement contentions, claim constructions, summary judgment orders, trial or settlement terms, and final judgment).
What is the case docket and procedural posture for ACRAFSpA v. Aurobindo Pharma USA (1:19-cv-02197)?
Answer: The docket number indicates a federal Hatch-Waxman dispute initiated in 2019 and assigned to the District of New Jersey. A litigation summary requires docket-level artifacts (complaint filing date, the list of asserted US patents, the ANDA applicant’s proposed product description, and the relief sought).
What procedural steps typically matter for investment and launch-risk decisions?
- Patent identification: asserted US patents and asserted claims.
- ANDA linkage: which NDA reference drug and which Orange Book patents are implicated.
- Remedies: permanent injunction request scope and notice of infringement allegations.
- Timelines: dates that control the 30-month stay, later lifting triggers, and any court-ordered schedule.
Which patents did ACRAFSpA assert against Aurobindo in 1:19-cv-02197?
Answer: Not available from the input provided.
What you need to confirm in the complaint to map exclusivity and generic entry risk
- Patent numbers and priority claims.
- Asserted independent and dependent claims.
- Alleged infringement theory (formulation, method-of-use, or composition claims).
- Non-infringement and invalidity grounds invoked by Aurobindo.
What does the litigation reveal about the Orange Book status of the reference listed drug?
Answer: Not available from the input provided.
Orange Book mapping checklist for this dispute
- Reference product name (NDA holder and NDA number).
- Listed patents and expiration dates.
- Patent categories: drug substance, drug product formulation, use, and manufacturing method.
- Whether the asserted patents are “listed for” the NDA or only for a specific strength or dosage form.
How does this lawsuit affect generic launch timing and exclusivity for Aurobindo’s ANDA?
Answer: Not available from the input provided.
What materially changes launch calendars
- Whether the case settled before final judgment.
- Whether Aurobindo received a covenant not to sue.
- Whether the stay was lifted by final court rulings (infringement/validity or procedural rulings).
- Whether there was a consent judgment defining “design-around” boundaries.
What was the case outcome: settlement, consent judgment, dismissal, or trial verdict?
Answer: Not available from the input provided.
Outcome artifacts that determine future enforcement strategy
- Dismissal order language (with/without prejudice).
- Settlement agreement scope (specific patents, specific strengths, specific dosage forms).
- Post-settlement enforcement rights (who can sue, for what conduct, and under what conditions).
- Any “carve-outs” for subsequent reformulations or authorized generics.
Was there any claim construction, summary judgment, or appellate activity in 1:19-cv-02197?
Answer: Not available from the input provided.
Why claim construction and dispositive rulings matter
- Construction impacts both validity and infringement.
- Summary judgment informs whether the asserted estate is strong or narrowing.
- Appellate activity changes enforceability risk and timing for generic launches.
How strong is ACRAFSpA’s patent estate based on the litigation record?
Answer: Not available from the input provided.
Patent-strength analysis requires these litigation facts
- Whether Aurobindo challenged validity under §101/§102/§103/§112 and results of those arguments.
- Whether the court addressed obviousness or enablement in a way that constrains the estate.
- Whether the court found infringement as to key claims.
What generic entry risks exist for other ANDA filers tied to the same Orange Book patents?
Answer: Not available from the input provided.
How to model third-party entry using a related Paragraph IV record
- Identify whether the settlement creates de facto precedent for non-parties.
- Determine if the court entered an injunction or a covenant with defined non-infringement boundaries.
- Assess whether other ANDAs can “trigger” a stay relief based on the same patent set.
How does Aurobindo’s litigation posture compare with other challengers against Angelini/Acraf?
Answer: Not available from the input provided.
Comparison requires competitor case linkage
- Which other ANDA applicants challenged the same Orange Book patents.
- Whether those cases settled on similar terms.
- Whether any of those disputes ended with invalidation or narrow claim interpretations.
Which regulatory milestones and FDA pathway facts matter for this dispute (ANDA, 505(b)(2), exclusivity, 30-month stay)?
Answer: Not available from the input provided.
Key FDA-linked facts to extract from docket-driven records
- ANDA filing date and paragraph IV certification paragraph.
- Court-ordered stay start and end.
- Whether FDA approved before final resolution.
Key Takeaways
- The docket number confirms a Hatch-Waxman patent dispute filed in 2019 in the District of New Jersey, but the input provided does not contain the substantive record needed to summarize asserted patents, procedural outcomes, claim rulings, or settlement terms.
- Without the complaint and disposition orders (or settlement publication), any attempt to state litigation outcomes, expiration impacts, or launch timing effects would not be accurate.
FAQs
- What is the typical information in a Paragraph IV complaint that maps to Orange Book exclusivity timelines?
- How do covenant-not-to-sue provisions in ANDA settlements affect subsequent generic entry and design-around attempts?
- What claim-construction issues most often drive settlement leverage in Hatch-Waxman disputes?
- How can a dismissal without prejudice versus with prejudice change enforcement for the patent owner?
- What FDA approval and labeling changes typically accompany settlement agreements in ANDA cases?
References
- None provided in the prompt (no docket filings, court orders, or Orange Book listings were included), so no sources can be cited.
