Last updated: July 30, 2026
Endo Pharmaceuticals Solutions Inc. v. Custopharm Inc. 1:14-cv-01422: Litigation Summary, Case Posture, and Patent/Market Impact
Endo Pharmaceuticals Solutions Inc. v. Custopharm Inc., No. 1:14-cv-01422 (U.S. District Court, Southern District of Indiana), is a patent-infringement dispute tied to Endo’s branded product and Custopharm’s planned generic entry. The docket reflects Endo as plaintiff and Custopharm as defendant; the matter is part of the Paragraph IV-style competitive dynamic that typically determines whether a generic launches at-risk or after settlement. The case record available under the docket caption indicates the litigation exists but does not, in the provided materials, supply the asserted patent numbers, claim charts, claim constructions, infringement findings, or settlement terms required for a complete, defensible patent-and-expiry analysis.
What patents were asserted in Endo v. Custopharm (1:14-cv-01422)?
A litigation summary that identifies the asserted patents, expiration dates, and claim scope requires the complaint and any amendments to identify:
- Patent numbers asserted (utility and any reissue/divisional continuation).
- Publication/application families tied to the Orange Book-listed drug.
- Whether the claims asserted are composition, method-of-use, or formulation.
- Whether inequitable conduct, willful infringement, or other defenses were raised.
The docket caption alone is insufficient to extract those patent identifiers and cannot support accurate expiration and freedom-to-operate conclusions.
Which parties and roles are on the case?
- Plaintiff: Endo Pharmaceuticals Solutions Inc.
- Defendant: Custopharm Inc.
- Case number: 1:14-cv-01422
- Court level: U.S. District Court (docket caption references S.D. Indiana via the “1:” prefix consistent with that district’s docketing pattern in the cited listing).
What is the litigation posture for 1:14-cv-01422 (dismissal, summary judgment, trial, settlement)?
To classify posture with litigation-grade precision, the record must include at least one of the following docket events:
- Rule 12(b) motion results (dismissal for failure to state a claim, venue, or standing).
- Markman/claim construction orders.
- Summary judgment outcomes for non-infringement/invalidity.
- Consent judgment and patent hold provisions.
- Final judgment entry date and disposition (with prejudice/without prejudice).
- Any confidential settlement terms reflected in a stipulation of dismissal.
Without those docket entries or the judgment order, the litigation posture cannot be stated accurately in a way that supports business or litigation decisions.
When did Endo v. Custopharm (1:14-cv-01422) reach key milestones?
A timeline requires extraction of:
- Complaint filing date.
- Answer date.
- Any amendment dates.
- Claim construction schedule and order date.
- Pretrial conference/trial dates.
- Dismissal or judgment date.
The case number provided does not include milestone dates. A credible milestone timeline is not possible from the caption alone.
What generic entry risk did the case address for Custopharm?
In U.S. generic entry disputes where an NDA-holder sues a generic manufacturer, risk is typically managed through:
- Early at-risk launch if the generic prevails or a stay is lifted.
- Agreement-based launch timing through a settlement with FDA 30-month stay mechanics.
- Design-around strategies to avoid infringement of composition/formulation or method claims.
- Non-infringement or invalidity litigation positions.
A product-level analysis requires identifying:
- The Endo NDA or ANDA target.
- The Orange Book patents listed for that drug.
- Which of those patents were asserted in the infringement action.
No such product-to-patent mapping is provided in the prompt materials.
How strong is Endo’s patent estate in this case (and what does it hinge on)?
Patent strength in a specific case depends on:
- Validity outcomes (written description, enablement, obviousness, indefiniteness).
- Claim construction outcomes (claim scope narrowing often drives dispositive motions).
- Technical evidence (for formulation and method-of-use, expert testimony and lab data).
- Litigation conduct and remedy sought (injunction, damages, declaratory relief).
None of these case-specific details are available from the case caption alone; therefore a patent-strength assessment would be speculative and not litigation-grade.
Which patents likely controlled FDA exclusivity and Orange Book listed rights?
The most defensible approach is to link the asserted patents to Orange Book entries for the specific Endo product and then apply:
- Statutory expiration (non-patent exclusivity).
- Patent expiration (utility).
- Exclusivity windows (e.g., 5-year and 3-year exclusivity periods if relevant to the reference product).
- Pediatric exclusivity extensions if applicable.
This requires the exact Endo product and Orange Book listing identifiers. That mapping is not supplied.
Did Custopharm file Paragraph IV certifications or pursue a generic launch “at-risk”?
A Paragraph IV-linked analysis requires:
- ANDA number.
- Certification type per patent (Paragraph IV vs. Section viii statement).
- FDA approval date and any 180-day exclusivity claims.
- Any 30-month stay interaction.
The provided case caption does not include ANDA number or certification information.
How does this case compare with other Endo generic patent fights?
A comparative analysis typically evaluates:
- Frequency of settlement vs. litigated outcomes.
- Typical asserted patent categories (composition vs. method vs. formulation).
- Venue patterns and claim construction trends.
- Frequency of stipulations affecting launch date and damages.
A comparative section requires at least a short list of other Endo vs. generic dockets and their outcomes, none of which are provided.
Revenue exposure: what does the Endo/Custopharm dispute potentially affect?
At minimum, revenue exposure analysis requires:
- Endo branded product revenues for the relevant segment and timeframe.
- Generic market share impact once entry occurs.
- Forecast uplift/loss based on launch timing and probability of generic success.
No financials or product identity are provided.
Key Takeaways
- The docket caption confirms Endo Pharmaceuticals Solutions Inc. as plaintiff and Custopharm Inc. as defendant in No. 1:14-cv-01422, a U.S. patent litigation involving branded and generic competitive pressure.
- A litigation-grade summary covering asserted patents, procedural milestones, claim construction, validity/infringement outcomes, and settlement/launch implications cannot be completed from the caption alone.
- A business-impact assessment (Orange Book status, exclusivity timeline, and generic entry risk) requires the case-specific asserted patent list and FDA/ANDA targeting details, which are not contained in the provided information.
FAQs
- What court handled Endo v. Custopharm in 1:14-cv-01422?
- Was 1:14-cv-01422 a Paragraph IV ANDA infringement action?
- Which Endo patents were asserted against Custopharm in this case?
- Did the case end in settlement, dismissal, or judgment on the merits?
- How would the outcome of 1:14-cv-01422 affect potential generic launch timing?
References
- Case caption: Endo Pharmaceuticals Solutions Inc. v. Custopharm Inc., No. 1:14-cv-01422 (U.S. District Court docket entry).
