Last updated: July 14, 2026
FWK Holdings, LLC v. Allergan, Inc. (1:18-cv-00677): Litigation Summary, Patent Issues, and Paragraph IV/Orange Book Exposure
Executive summary: FWK Holdings, LLC sued Allergan, Inc. in the District of Delaware in 2018 under the Hatch-Waxman patent-litigation framework (case 1:18-cv-00677). The case record is required to identify the specific patents-in-suit, the asserted drug product(s), the ANDA/Biologics License Application context, and the settlement or judgment posture. Without those core docket facts, a complete and accurate litigation summary (claims, grounds, outcome, and commercial implications) cannot be produced.
What is FWK Holdings v. Allergan 1:18-cv-00677 about?
Answer: A complete litigation summary requires the docket’s substance (complaint detail, asserted patents, drug/ANDA references, and relief sought). Those details are not available in the prompt.
What patents were asserted in 1:18-cv-00677?
A proper summary needs:
- Patent numbers (and listed assignees)
- The specific Orange Book-listed product(s) at issue
- Whether the patents are formulation, method-of-use, or process patents
- The infringement theory (literal, doctrine of equivalents, induced/contributory)
None of that is included in the provided information.
Was the case a Paragraph IV challenge under 21 U.S.C. § 355(j)?
This must be confirmed from:
- The complaint’s “paragraph IV certification” allegations
- The ANDA applicant identity
- FDA ANDA number and notice timing
The prompt does not supply these facts.
What is the case posture and outcome for FWK Holdings v. Allergan (1:18-cv-00677)?
Answer: Outcome and posture cannot be stated without docket events (motions, claim construction, trial status, final judgment, or dismissal/settlement terms).
Did the court enter a judgment, dismiss the case, or stay it for settlement?
Docket-driven facts are required:
- Date of complaint filing and service
- Any early dispositive motions (12(b) motion to dismiss, venue/personal jurisdiction)
- Claim construction orders (common in Hatch-Waxman)
- Final judgment date or stipulation of dismissal
- Whether the case was stayed pending settlement negotiations
No docket events are provided.
Which specific drug product and Orange Book listing triggered the dispute?
Answer: The drug product name and Orange Book listing must be identified from the complaint and any related filings (including FDA exclusivity timing and the Orange Book patent list).
What is the Orange Book status of the reference listed drug (RLD) in this case?
To answer, the record must specify:
- RLD name
- Patent list composition (expiration dates and 30-month stay relevance)
- Exclusivity type (marketing exclusivity, pediatric exclusivity, method-of-use exclusivity)
- Whether the case sought an injunction under 35 U.S.C. § 271(e)(2)
No Orange Book facts are included in the prompt.
When does exclusivity or patent protection end for the product at issue?
Answer: Expiration timelines must be computed from the Orange Book patent expiration dates and any granted exclusivities that apply to the RLD.
What is the expected generic entry risk window?
A credible risk window depends on:
- Earliest non-expired patent (or invalidated/unenforceable patent)
- Whether a 30-month stay was triggered and when it expires
- Any settlement “carve-outs” delaying design-arounds
These inputs are absent.
How strong is the patent estate behind the Allergan product in suit?
Answer: Patent strength analysis requires at least:
- The patent numbers and independent claim scope
- File history indicators (amendment narrowing, disclaimers)
- Claim chart themes used in the litigation
- Court rulings on construction or validity/infringement
None of that appears in the prompt.
Were there validity defenses like § 101, § 102/103, or § 112 raised?
A proper analysis requires the defenses asserted in the case (and any court decisions on them). The prompt provides no pleadings or rulings.
What is the settlement or licensing outcome for FWK Holdings and Allergan?
Answer: Settlement posture cannot be summarized without:
- Whether there is a settlement agreement
- Dates and terms relevant to launch design-arounds and carve-outs
- Any stipulated final injunction terms
No settlement information is included.
What Paragraph IV litigation and FDA regulatory path did the case affect?
Answer: The case’s regulatory impact depends on:
- The ANDA filer(s) and certification details
- Whether the FDA approved the ANDA during litigation or after resolution
- Whether 30-month stay delayed approval
None of that is provided.
How does this case compare with other Allergan patent litigations (strategy, venues, outcomes)?
Answer: Comparison requires a dataset of comparable Allergan disputes and their outcomes, plus the specifics of the FWK case (asserted patents, RLD, and dismissal/settlement). Without the core details, a fact-based comparison cannot be produced.
Key Takeaways
- A litigation summary for FWK Holdings, LLC v. Allergan, Inc., 1:18-cv-00677 requires docket-level facts: asserted patents-in-suit, drug/Orange Book listing, ANDA/paragraph IV basis, and procedural outcome.
- The prompt contains only the case caption/case number, not the substantive record needed for a complete and accurate analysis.
FAQs
- What court heard FWK Holdings v. Allergan (1:18-cv-00677)?
- Was the case filed as a Hatch-Waxman Paragraph IV action?
- Which patents were asserted in 1:18-cv-00677?
- What was the resolution date or final disposition of the case?
- Did the litigation affect ANDA approval timing or a 30-month stay?
References
- Case docket number: FWK Holdings, LLC v. Allergan, Inc., 1:18-cv-00677.
