AbbVie v. MSN Pharmaceuticals — UBRELVY® Ubrogepant Patent Infringement Dispute
AbbVie, Merck Sharp & Dohme, and Allergan jointly sued MSN Pharmaceuticals and its affiliates in the District of New Jersey over four patents protecting UBRELVY® (ubrogepant) 50 mg and 100 mg oral tablets, a CGRP receptor antagonist approved for acute migraine. The case closed after 604 days with a stipulated dismissal without prejudice, preserving all claims and defenses for any future action involving a different MSN product or ANDA.
UBRELVY® ANDA Battle Ends Without Merits Ruling, Claims Preserved
Filed on 8 April 2024 in the District of New Jersey, this Hatch-Waxman action saw AbbVie Inc., Merck Sharp & Dohme LLC, and Allergan Pharmaceuticals International Limited assert four US patents — US11857542B2, US11717515B2, US10117836B2, and US11925709B2 — against MSN Pharmaceuticals Inc., MSN Laboratories Private Limited, and MSN Life Sciences Private Limited. The suit was triggered by MSN’s ANDA No. 219218, seeking FDA approval for generic ubrogepant oral tablets in 50 mg and 100 mg dosages, therapeutically equivalent to AbbVie’s UBRELVY®, a CGRP receptor antagonist indicated for acute migraine treatment in adults.
The case closed on 3 December 2025 via a stipulated dismissal without prejudice. Critically, the stipulation is expressly limited in scope: it operates only with respect to ANDA No. 219218 covering generic ubrogepant oral tablet products at the specified dosage strengths. The dismissal explicitly preserves all claims, defenses, and counterclaims that either party may raise in any possible future action — meaning AbbVie and co-plaintiffs retain the full right to re-file if MSN pursues a different product or ANDA referencing the asserted patents.
At 604 days, the case ran longer than many Hatch-Waxman disputes that settle early, suggesting substantive litigation activity occurred before the parties reached this resolution. The narrowly scoped stipulation language — limiting the dismissal strictly to the named ANDA and product — is a deliberate drafting choice consistent with plaintiffs protecting their enforcement position. The public record does not disclose any licensing agreement, commercial settlement terms, or consent judgment, leaving the commercial relationship between the parties unclear beyond what the stipulation states.
Filing to Dismissed without Prejudice in 604 days
604 days — above average for a Hatch-Waxman ANDA case to resolve pre-trial in D.N.J.
Dismissed without prejudice: what the stipulation means for both parties
Dismissal without prejudice via stipulation — no merits adjudicated
A dismissal without prejudice means the court made no ruling on patent validity, infringement, or enforceability. The case was ended by mutual consent through a formal stipulation and court order. Crucially, this specific dismissal is expressly confined to ANDA No. 219218 and the named ubrogepant tablet products — it does not release any claims beyond that narrow scope.
No validity ruling madeAbbVie retains full enforcement rights against MSN on other products
The stipulation’s without-prejudice nature means AbbVie, Merck, and Allergan can re-file against MSN at any time if MSN files a new or amended ANDA, seeks approval for a different formulation, or otherwise triggers the patents again. The four asserted patents remain in force and unchallenged on the merits. This outcome is tactically favourable: no adverse validity finding was entered.
Patents unchallenged on meritsMSN avoids adverse ruling but faces re-litigation risk on any new ANDA
MSN Pharmaceuticals and its affiliates escape an adverse patent judgment and preserve their own defenses and counterclaims intact. However, the explicit preservation clause means MSN cannot treat this dismissal as any form of patent clearance. If MSN proceeds with ANDA No. 219218 or files a related application, plaintiffs may reinstate litigation. MSN’s path to generic ubrogepant market entry remains legally uncertain.
No patent clearance obtainedUBRELVY® patent fortress remains intact — generic entry still blocked
With no invalidity or non-infringement finding, the four ubrogepant patents retain full deterrent force against all generic entrants, not just MSN. Other ANDA filers referencing UBRELVY® face the same enforcement posture. For the migraine CGRP antagonist market, this outcome suggests AbbVie and partners are willing to litigate assertively while preserving flexibility to negotiate product-by-product resolutions.
Generic entry remains uncertainFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | AbbVie, Inc. | Company | Biopharmaceutical patent enforcer — holder of US11857542B2 and three further ubrogepant patentsSearch in Eureka ↗ |
| Co-Plaintiff | Merck Sharp & Dohme, LLC | Company | Search in Eureka ↗ |
| Co-Plaintiff | Allergan Pharmaceuticals International Limited | Individual | Search in Eureka ↗ |
| Defendant | Msn Pharmaceuticals, Inc. | Company | Indian generic pharmaceutical manufacturer seeking US market entry via ANDA No. 219218 for ubrogepant tabletsSearch in Eureka ↗ |
| Co-Defendant | MSN Laboratories Private Limited | Individual | Search in Eureka ↗ |
| Co-Defendant | Msn Life Sciences Private Limited | Individual | Search in Eureka ↗ |
| Plaintiff counsel | Jose Luis Linares | Attorney | Counsel for AbbVie, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Mark M. Makhail | Attorney | Counsel for AbbVie, Inc.Search in Eureka ↗ |
| Plaintiff counsel | SHANNON M. PATRICK | Attorney | Counsel for AbbVie, Inc.Search in Eureka ↗ |
| Plaintiff counsel | SHIVANI KARTHIKEYAN | Attorney | Counsel for AbbVie, Inc.Search in Eureka ↗ |
| Plaintiff law firm | McCarter & English LLP | Law Firm | Representing AbbVie, Inc.Search in Eureka ↗ |
| Defendant counsel | Gregory D. Miller | Attorney | Counsel for Msn Pharmaceuticals, Inc.Search in Eureka ↗ |
| Defendant counsel | MARCUS O. TUBIN | Attorney | Counsel for Msn Pharmaceuticals, Inc.Search in Eureka ↗ |
| Defendant counsel | Timothy P. Gonzalez | Attorney | Counsel for Msn Pharmaceuticals, Inc.Search in Eureka ↗ |
| Defendant law firm | Rivkin Radler LLP | Law Firm | Representing Msn Pharmaceuticals, Inc.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | New Jersey District CourtSearch in Eureka ↗ |
Official order — verbatim text
The stipulation’s operative language is carefully cabined: the without-prejudice dismissal applies solely to claims arising from ANDA No. 219218 for 50 mg and 100 mg generic ubrogepant tablets. This scoping is legally significant — it forecloses any argument that the dismissal constitutes a release, covenant not to sue, or estoppel on the four asserted patents in any other context. Both parties retain their full legal arsenals, and the court order gives this mutual understanding binding force. The absence of any merits determination means the patents’ validity and infringement questions remain live for future proceedings.
US11857542B2, US11717515B2, US10117836B2 & US11925709B2 — Ubrogepant Formulation Patents
The four asserted patents — US11857542B2, US11717515B2, US10117836B2, and US11925709B2 — collectively protect the composition, formulation, and therapeutic application of ubrogepant, the active ingredient in UBRELVY®. Ubrogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist approved for acute treatment of migraine with or without aura in adults. The patents span application filings from US15/115026 through to US18/210719, reflecting an evolving prosecution strategy that extends protection from core compound claims through to more recent formulation and dosing innovations.
UBRELVY® represented a significant commercial milestone as one of the first orally administered small-molecule CGRP antagonists approved in the US, competing in a migraine market that also includes monoclonal antibody CGRP therapies. The breadth of a four-patent portfolio — with differing claim scopes and expiry dates — creates a substantial barrier for generic manufacturers, requiring each ANDA applicant to either design around all asserted claims or successfully invalidate or distinguish each patent. For competitors and investors in the migraine therapeutics space, the continued enforceability of this portfolio is a material commercial variable.
Should you run an FTO against US11857542B2 and the UBRELVY® ubrogepant patent estate?
Any pharmaceutical company developing, formulating, or seeking ANDA approval for a CGRP receptor antagonist — particularly ubrogepant or structurally similar gepant-class compounds — should treat this four-patent portfolio as a priority FTO target. The without-prejudice dismissal in this case confirms that AbbVie, Merck, and Allergan remain in an active enforcement posture and have explicitly reserved all rights. Generic manufacturers, contract drug formulators, and branded competitors entering the acute migraine oral therapeutics space face real re-litigation exposure.
PatSnap Eureka’s FTO Search Agent can map each of the four asserted patents’ independent and dependent claims against your specific compound, formulation, or manufacturing process — identifying genuine freedom-to-operate or flagging overlap that warrants design-around analysis. Eureka also tracks downstream continuation and divisional applications from the same patent families, alerting you to new patent grants that could extend AbbVie’s enforcement reach beyond current ANDA-based disputes.
Run a freedom-to-operate analysis on US11857542B2 to assess your product’s exposure
Run FTO in Eureka →Similar CGRP Antagonist & Hatch-Waxman ANDA Cases in D.N.J.
Cases involving CGRP receptor antagonist formulation patents and Hatch-Waxman ANDA infringement actions litigated in the District of New Jersey.
What this case signals for the CGRP antagonist and migraine IP landscape
AbbVie’s coordinated multi-plaintiff strategy and narrowly scoped dismissal reveal a disciplined enforcement posture around UBRELVY®’s patent estate.
Without-prejudice dismissal is not patent clearance — monitor MSN’s ANDA pipeline
The explicit preservation language in the stipulation confirms that no licensing safe harbour was granted to MSN. Companies tracking generic ubrogepant entry should monitor FDA’s Paragraph IV certification database for any new or amended ANDAs from MSN entities, as fresh litigation could follow promptly.
Four-patent assertion signals a layered IP strategy around ubrogepant formulations
Asserting four distinct patents — covering different aspects of ubrogepant composition, dosage, and method of use — reflects a portfolio-layering approach typical of blockbuster small-molecule defence. Each patent carries independent expiry, making design-around strategies more complex and costly for generic manufacturers.
AbbVie v Msn — key questions answered
The dismissal without prejudice means no court ruled on whether MSN’s proposed generic ubrogepant tablets infringe or whether the four asserted patents are valid. AbbVie, Merck, and Allergan retain the right to re-file against MSN if a new or different ANDA is filed. Generic ubrogepant market entry by MSN remains legally unresolved.
AbbVie, Merck Sharp & Dohme, and Allergan asserted four patents: US11857542B2, US11717515B2, US10117836B2, and US11925709B2. All four relate to ubrogepant — the active ingredient in UBRELVY® — covering formulation compositions, dosage forms, and methods of use for acute migraine treatment.
The 604-day duration before a stipulated dismissal is longer than many Hatch-Waxman matters that settle early. This timeline is consistent with substantive litigation activity — potentially including discovery, claim construction briefing, or expert exchanges — before the parties reached a without-prejudice resolution. No court order explains the specific procedural history beyond the final stipulation.
No. The stipulation expressly states it is without prejudice to any claim, defense, or counterclaim in any possible future action between the MSN defendants and plaintiffs regarding the asserted patents and any product other than generic ubrogepant oral tablet products described by ANDA No. 219218. AbbVie’s enforcement rights are fully preserved.
Ubrogepant is a small-molecule CGRP receptor antagonist approved for acute migraine treatment, marketed as UBRELVY® by AbbVie. It was among the first orally administered gepant-class therapies to receive FDA approval, competing in a high-value migraine market. Its four-patent portfolio creates a layered enforcement barrier that requires generic entrants to clear multiple independent patent claims before launching.
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