Last updated: July 12, 2026
What patents were at issue in Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc. (1:11-cv-02466)?
A complete litigation-and-patent issue map cannot be produced from the case identifier alone. The docket number (1:11-cv-02466) does not specify the asserted drug product, Orange Book patents, patent numbers, claims, or whether the dispute proceeded under Hatch-Waxman, federal trademark, antitrust, or another theory. Without the asserted patent list and the complaint/Amended Complaint and claim charts (or the court’s claim-construction and infringement rulings), a factual summary would be incomplete.
What was the procedural posture of 1:11-cv-02466 and how did the court rule?
No answer can be provided without the docket’s substantive entries. A “procedural posture” summary requires at least the case captioned claims, the sequence of filings (complaint, answer, motions to dismiss, summary judgment, preliminary injunction motions, claim construction, trial/disposition), and the dispositive order(s). Those are not contained in the case number.
Which claims did Par Pharmaceutical assert against TWi in this case?
A claims summary requires the specific causes of action pled. In pharma litigation, the most common categories are:
- Hatch-Waxman patent infringement (35 USC § 271(e)(2)),
- Declaratory judgment of non-infringement/invalidity,
- Injunctive relief tied to FDA approval timing,
- State-law unfair competition or Lanham Act theories,
- Antitrust or settlement-related restraint claims.
The case number alone does not identify which legal theories were asserted.
When did Par Pharmaceutical sue TWi and what triggered the suit?
An accurate “when” and “what triggered” timeline depends on:
- the complaint filing date,
- the ANDA/NDA and submission dates (or Paragraph IV notice dates),
- whether TWi sought approval for a generic or a particular dosage form,
- whether Par alleged infringement of specific listed Orange Book patents.
Those details are not inferable from 1:11-cv-02466.
Was this Hatch-Waxman Paragraph IV litigation or something else?
A determination of Paragraph IV status requires Orange Book context and the asserted patent list, or explicit references in the complaint to 21 USC § 355(j), notice provisions, or 35 USC § 271(e)(2). The case identifier alone is insufficient to confirm the statutory posture.
What is the Orange Book status of the asserted drug and who listed the patents?
Orange Book status requires:
- the NDA/ANDA number for the reference listed drug (RLD),
- the specific listed patents (US numbers, publication/expiry, patent type: composition, method-of-use, formulation, device, packaging, etc.),
- the Orange Book “expiration” and “pediatric exclusivity” flags.
None of this can be derived from the docket number.
How many patents were asserted and what patent types were involved (composition, method-of-use, formulation)?
A count by patent type requires the asserted patent list from the complaint and any later amendments. Without docket documents that list the patents and claims, a quantitative estate analysis would be fabricated.
When do the relevant patents expire, and what exclusivity timelines applied?
Patent expiration analysis requires the specific US patents (or application publications), their filing/priority dates, PTA, and any exclusivity grants (30-month stay, pediatric exclusivity, orphan exclusivity). No such facts are available from the docket number alone.
How strong is the patent estate in this dispute: validity, infringement, and claim construction?
A strength analysis requires:
- claim construction outcomes,
- infringement findings (literal and DOE),
- validity rulings (anticipation/obviousness/indefiniteness, written description/enablement, § 101 if applicable),
- appellate posture if any.
Those are not available from the case number alone.
What settlement terms or consent decrees affected generic entry risk?
Settlement and consent judgment terms require docket access or a publicly posted settlement agreement summary. Without it, any “entry-risk” narrative would be ungrounded.
Did TWi launch during the case, and what was the injunction or stay outcome?
Launch timing, FDA approval dates, and injunction outcomes are fact-specific:
- court-granted preliminary injunction? yes/no,
- 30-month stay status,
- final infringement/invalidity outcome,
- whether any generic entry proceeded after a non-final order.
Those facts cannot be produced from 1:11-cv-02466 alone.
Which other companies were involved (co-defendants, counterclaims, or related cases)?
Multi-party pharma dockets often include additional defendants, ANDA applicants, or distributor entities. A relationship map requires docket captions and filings.
Which manufacturing/IP barriers mattered (process patents, bioavailability, NDA supplements)?
Barriers analysis depends on whether the case asserted manufacturing/process patents, formulation patents, or performance standards for generic substitution. Without the asserted patents and product description, the analysis cannot be completed.
How does this litigation compare with other Par Pharmaceutical generic patent disputes?
Comparison requires at least one of:
- the drug product and patent estate,
- the court’s outcomes,
- similar procedural outcomes in other Par cases.
None of those are specified by the case number.
Key Takeaways
A precise litigation summary and patent/regulatory analysis for Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc. (1:11-cv-02466) cannot be generated without the underlying docket record and complaint-specific patent and claims information. The case identifier alone does not provide the asserted patent numbers, drug product, legal theories, or disposition necessary to produce a factual, decision-grade analysis.
FAQs
- What drug and FDA application were implicated in Par v. TWi (1:11-cv-02466)?
- Which specific Orange Book patents did Par assert against TWi?
- Did the court issue a preliminary injunction or grant summary judgment in 1:11-cv-02466?
- What was the final outcome for TWi’s generic launch eligibility?
- Were there any related appeals, remands, or parallel dockets linked to 1:11-cv-02466?
References (APA)
- Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc., No. 1:11-cv-02466 (Docket).
