Last updated: July 22, 2026
OREXO AB v. Sun Pharma (3:21-cv-17941): Litigation Summary, Patent Issues, and Generic Risk Analysis
A U.S. Hatch-Waxman patent infringement case is pending in the Southern District of New York under docket 3:21-cv-17941, styled OREXO AB v. Sun Pharmaceutical Industries Ltd. The litigation centers on Orange Book-listed intellectual property for Orexo’s branded product and Sun’s plan to market a generic version. The case posture, patent-specific claims, and whether any “carve-out” settlement or launch trigger exists cannot be determined from the information available in this session.
What is the case docket 3:21-cv-17941 and what court governs OREXO v. Sun Pharma?
Court and docket
- Court: U.S. District Court for the Southern District of New York
- Case number: 3:21-cv-17941
- Caption: OREXO AB v. Sun Pharmaceutical Industries Limited
Stage and procedural posture
- Not determinable from the provided input.
What claims are typically asserted in Orexo versus generic manufacturers under Hatch-Waxman?
- Patent infringement under 35 U.S.C. § 271(e)(2) tied to an Abbreviated New Drug Application (ANDA).
- Typical asserted categories in Orexo disputes (by common pattern, not case-specific confirmation):
- Composition or dosage form patents
- Method-of-use or treatment patents
- Formulation or manufacturing method patents
- Trigger-specific secondary patents tied to release profiles, polymers, or abuse-deterrent structures
Which patents are at issue in OREXO AB v. SUN PHARMACEUTICAL INDUSTRIES LIMITED (3:21-cv-17941)?
A complete and accurate answer is not possible from the input provided in this session.
What patent numbers and Orange Book listings usually appear in these disputes?
- Orange Book listing details are necessary to map:
- NDA/ANDA reference product
- Patent list numbers
- Expiration dates
- Exclusivity periods
- 35 U.S.C. § 271(e)(2) claims tied to each patent
When does exclusivity end for Orexo’s listed product and what patent expirations matter for Sun’s generic?
A litigation and exclusivity timeline cannot be constructed without the reference product NDA, Orange Book patent numbers, and the court’s ruling or schedule.
How do Hatch-Waxman timelines affect generic entry risk?
- If Sun’s ANDA is blocked by one or more asserted patents:
- Entry is delayed until:
- patent expiration, or
- a final non-infringement/non-validity judgment, or
- a settlement authorizing earlier launch, or
- a procedural dismissal.
- If only some patents are asserted:
- The unasserted patents typically do not block entry, but the first final judgment can still set practical launch timing if stipulated.
What is the litigation status (motions, rulings, trial) in 3:21-cv-17941?
The procedural history and current status are not determinable from the information provided in this session.
Which procedural events usually drive settlement or launch decisions?
- Claim construction (Markman) rulings
- Summary judgment on non-infringement or invalidity
- Motions to dismiss (failure to state a claim, jurisdictional issues)
- Case management orders affecting schedule
- PTO-related events such as reexamination or IPR outcomes (if any)
How strong is Orexo’s patent estate versus Sun’s generic entry risks in this case?
A strength analysis requires:
- The asserted patents and claim themes
- Prior art and prosecution history context
- The infringement theory and Sun’s product design
- Any rulings already entered by the court
None of those specifics are available in this session.
What infringement themes often decide Orexo formulation disputes?
- Whether the generic matches:
- release kinetics and dissolution parameters
- polymer/drug layering or coating architecture
- abuse-deterrent mechanisms (if applicable)
- manufacturing method steps tied to critical parameters
What Paragraph IV or other ANDA certification is involved in OREXO v. Sun?
The ANDA certification type (Paragraph IV vs. Paragraph III vs. “not for this patent”) cannot be determined from the input provided in this session.
Why Paragraph IV certification drives the key litigation lever
- Paragraph IV triggers:
- immediate patent infringement suit
- potential 30-month stay of ANDA approval (subject to outcomes and statutory carve-outs)
What settlement terms are in play in OREXO v. Sun (3:21-cv-17941)?
Settlement terms cannot be summarized from the information provided in this session.
How to interpret settlements in Orexo generics disputes
- Typical settlement mechanics include:
- agreed “no earlier than” launch dates
- covenant not to sue during the defined window
- stipulated dismissal of claims after payment or royalty
- product labeling or design changes (sometimes required)
What is the FDA and Orange Book status of the product referenced by OREXO in this litigation?
Orange Book listing, FDA approval history, and exclusivity cannot be identified from the provided input in this session.
What Orange Book fields matter for a licensing and litigation timeline
- NDA number
- patent list numbers and expiry dates
- exclusivity type (NCE, 505(b)(2), pediatric, orphan)
- patent expiry vs exclusivity end dates for launch planning
How does OREXO’s litigation strategy against Sun compare with similar Orexo generic challenges?
Comparative analysis requires knowing:
- the asserted patent clusters
- the product(s) at issue
- the forum and outcomes
- whether the manufacturer is the same Sun entity or related affiliates
No such data is available in this session.
Key Takeaways
- The docket 3:21-cv-17941 is in the Southern District of New York with OREXO AB as plaintiff and Sun Pharmaceutical Industries Ltd. as defendant.
- A full litigation summary and patent-specific analysis cannot be produced from the provided information in this session.
- Without the product identity, Orange Book patent list, asserted patent numbers, and procedural rulings, it is not possible to state:
- which patents are at issue,
- the infringement/invalidity theories,
- the current case posture,
- exclusivity or launch timing,
- settlement scope,
- or generic entry risk.
FAQs
1) What is the plaintiff and defendant in case 3:21-cv-17941?
- Plaintiff: OREXO AB
- Defendant: Sun Pharmaceutical Industries Limited
2) What type of case is 3:21-cv-17941 under Hatch-Waxman?
- It is a U.S. patent infringement action tied to an ANDA-related dispute pattern, but the exact certification type and asserted patents are not provided in the input.
3) Where is the lawsuit filed and who is the presiding court?
- U.S. District Court for the Southern District of New York
4) Does this case impose a 30-month stay on Sun’s ANDA approval?
- Not determinable without ANDA certification details and any relevant court or statutory events.
5) What is the expected impact of this litigation on generic launch timing?
- The impact depends on the asserted patent claims, procedural stage, and any settlement authorizing earlier launch; those facts are not provided.
References
- None cited.
