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AbbVie v. Sun Pharma: Elagolix ANDA Patent Dispute | PatSnap
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Case ID1:23-cv-00684
FiledJun 2023
ClosedJun 2024
Patent Litigation

AbbVie v. Sun Pharma: Elagolix ANDA Blocked by Consent Injunction

AbbVie filed suit in Delaware against Sun Pharmaceutical over ANDA 215804 seeking generic elagolix sodium tablets (150 mg and 200 mg), asserting four patents covering compositions and processes. The case resolved in 364 days via a stipulated consent order — Sun is permanently enjoined from launching its generic for the life of all four patents, absent a licence or successful invalidity finding.

Resolution time
364days
364 days — resolved within one year, faster than the median Hatch-Waxman district court timeline
Patents asserted
1
US11542239B2 and 3 further patents asserted (ʼ983, ʼ572, ʼ351, ʼ239)
Outcome
Dismissed without Prejudice
Stipulated injunction entered — Sun enjoined for life of four elagolix patents
Cost ruling
Each Party Bears Own
No costs or fees awarded; parties resolved by mutual stipulation
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

AbbVie locks out Sun Pharma’s generic elagolix launch via stipulated injunction

On 23 June 2023, AbbVie, Inc. filed a Hatch-Waxman patent infringement action in the District of Delaware against Sun Pharmaceutical Industries, Inc., challenging Sun’s ANDA 215804, which sought FDA approval to market generic elagolix sodium oral tablets at 150 mg and 200 mg equivalents — the active ingredient in AbbVie’s Orilissa® (endometriosis) and Oriahnn® (uterine fibroids) products. AbbVie asserted six patents in total, including US11542239B2 and US11344551, covering elagolix compositions, formulations, and manufacturing processes.

The action resolved on 21 June 2024 — one day short of exactly one year after filing — through a stipulated consent order entered by Judge Jennifer L. Hall. The order formally adjudges that Sun’s ANDA filing constituted technical infringement of four patents (the ʼ983, ʼ572, ʼ351, and ʼ239 patents) under 35 U.S.C. § 271(e)(2)(A). Two earlier-asserted patents (the ʼ927 and ʼ551 patents) were dismissed from the action pursuant to a March 2024 court order. Sun is permanently enjoined from making, using, or selling the ANDA products in the United States for the life of the four remaining patents, including extensions and paediatric exclusivities, unless all claims are found invalid or unenforceable.

Resolution in under 365 days is notably swift for a multi-patent Hatch-Waxman dispute, suggesting the parties likely reached a negotiated settlement — potentially including a licence or agreed entry date — with the consent order serving as the public legal instrument. The public record does not disclose any confidential licence terms or authorised generic arrangements. The order expressly preserves Sun’s right to challenge the four patents in any future action involving a different product, keeping the door open for continued IP engagement between the parties.

Case at a glance
Case no.1:23-cv-00684
PlaintiffAbbVie, Inc.
CourtDelaware
JudgeJennifer L. Hall
FiledJune 23, 2023
ClosedJune 21, 2024
Duration364 days
OutcomeDismissed without Prejudice
Verdict causeInfringement Action
BasisDismissed without Prejudice
Prior Art Intelligence
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Case data sourced from PACER / Delaware District Court via PatSnap Eureka Litigation Intelligence Explore similar cases ↗
Case timeline

Filing to Dismissed without Prejudice in 364 days

364 days — resolved within one year, faster than the median Hatch-Waxman district court timeline

Case timeline: Complaint filed JUN 23 2023, DEC–JAN — 364 days total Horizontal timeline showing the three key events in AbbVie, Inc. v Sun Pharmaceutical Industries, Inc. from filing to resolution. Source: PACER, Delaware District Court. JUN 23 2023 Complaint filed Pre-trial proceedings JUN 21 2024 Dismissed without Prejudice 364 DAYS TOTAL
Dismissal terms

Consent injunction entered: what the stipulated order means for both parties

Legal mechanism

Stipulated consent order under § 271(e)(2)(A) — what it means

Under 35 U.S.C. § 271(e)(2)(A), the mere filing of an ANDA referencing a patented drug constitutes a technical act of infringement, enabling the brand to litigate before any generic launch. Here, both parties jointly requested the court enter a consent order formally adjudging infringement of four patents. This is a negotiated resolution — not a contested finding — but it carries full legal force as a court judgment, including a permanent injunction binding Sun and its affiliates.

Hatch-Waxman § 271(e)(2)(A)
Patent holder outcome

AbbVie secures patent-life exclusivity for elagolix without full trial

AbbVie obtained an enforceable permanent injunction covering Sun’s ANDA 215804 products for the full remaining life of all four asserted patents, plus any extensions and paediatric exclusivities. Crucially, the injunction falls away only if all claims of all four patents are found invalid or unenforceable by a final, non-appealable judgment. This is a high bar — any single surviving claim in any single patent sustains the block. AbbVie also retained two dropped patents (ʼ927, ʼ551) for use against other potential ANDA filers.

Injunction secured — all four patents
Generic challenger outcome

Sun Pharma’s ANDA 215804 launch is blocked — but future challenges preserved

Sun is enjoined from commercialising its 150 mg and 200 mg elagolix sodium generic tablets for the life of the four patents. Both parties waived appeal rights under the stipulation. However, the order is expressly without prejudice to future litigation involving these patents and a different product — meaning Sun retains the ability to file a new ANDA or challenge the patents in a separate action. The scope of any confidential licence or authorised-entry agreement remains undisclosed on the public record.

ANDA blocked — appeal waived
Commercial implications

Elagolix generic entry timeline pushed out — sector watching patent expiries

With Sun’s ANDA enjoined for the patent term, generic elagolix competition from this filer is effectively delayed to the expiry or invalidation of the last surviving patent among the four. Given AbbVie’s layered patent portfolio (six patents originally asserted), the elagolix franchise appears well-fortified against this specific challenger. Other potential ANDA filers face a clear signal that AbbVie will litigate aggressively and seek consent injunctions. Competitors and payers should monitor patent expiry dates and any IPR or inter partes review proceedings targeting the ʼ983, ʼ572, ʼ351, and ʼ239 patents.

Generic entry delayed — monitor IPR risk
Legal analysis based on PACER docket records for case 1:23-cv-00684 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffAbbVie, Inc.CompanyGlobal biopharmaceutical company — holder of elagolix sodium composition and process patentsSearch in Eureka ↗
DefendantSun Pharmaceutical Industries, Inc.CompanyGeneric pharmaceutical manufacturer seeking FDA approval via ANDA 215804 for elagolix sodium tabletsSearch in Eureka ↗
Plaintiff counselJack B. BlumenfeldAttorneyCounsel for AbbVie, Inc.Search in Eureka ↗
Plaintiff counselJeremy A. TiganAttorneyCounsel for AbbVie, Inc.Search in Eureka ↗
Plaintiff counselMegan Elizabeth DellingerAttorneyCounsel for AbbVie, Inc.Search in Eureka ↗
Plaintiff law firmMorris, Nichols, Arsht & Tunnell LLPLaw FirmRepresenting AbbVie, Inc.Search in Eureka ↗
Defendant counselAnne Shea GazaAttorneyCounsel for Sun Pharmaceutical Industries, Inc.Search in Eureka ↗
Defendant counselCaroline L. MarsiliAttorneyCounsel for Sun Pharmaceutical Industries, Inc.Search in Eureka ↗
Defendant counselJennell C. BilekAttorneyCounsel for Sun Pharmaceutical Industries, Inc.Search in Eureka ↗
Defendant counselMitchell R. WilliamsAttorneyCounsel for Sun Pharmaceutical Industries, Inc.Search in Eureka ↗
Defendant counselSamantha G. WilsonAttorneyCounsel for Sun Pharmaceutical Industries, Inc.Search in Eureka ↗
Defendant counselSamuel T. LocknerAttorneyCounsel for Sun Pharmaceutical Industries, Inc.Search in Eureka ↗
Defendant law firmYoung Conaway Stargatt & Taylor, LLPLaw FirmRepresenting Sun Pharmaceutical Industries, Inc.Search in Eureka ↗
Presiding judgeJudge Jennifer L. HallJudgeDelaware District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“Accordingly, pursuant to the above Stipulation, and upon the consent and request of Plaintiffs and Sun, IT IS HEREBY ORDERED, ADJUDGED AND DECREED THAT: The filing of ANDA 215804 was a technical act of infringement of each of the ‘983 Patent, the ‘572 Patent, the ‘351 Patent, and the ‘239 Patent under 35 U.S.C. § 271(e)(2)(A). 1 Plaintiffs also had asserted U.S. Patent Nos. 7,056,927 ("the ‘927 Patent") and 11,344,551 ("the ‘551 Patent") against Sun, however, all claims and defenses asserted by Plaintiffs and/or Sun related to the ‘927 Patent and the ‘551 Patent have been dismissed from the Action subject to the provisions of the Court’s March 5, 2024 Order. (D.I. 195). 2 Case 1:23-cv-00684-JLH Document 11-1 Filed 06/21/24 Page 3 of 4 PagelD #: 709 All other claims and defenses asserted by the parties against each other in Plaintiffs’ and Sun’s pleadings in the Action, including the allegations and averments contained therein are hereby dismissed, without prejudice. 3. notice of this Order by personal service or otherwise, are hereby enjoined from manufacturing, using, offering to sell, or selling within the United States, or importing into the United States, the generic elagolix sodium oral tablet products (eq. 150 mg base, eq. 200 mg base) described by ANDA 215804 during the life of any of the ‘983 Patent, the ‘572 Patent, the ‘351 Patent, and the ‘239 Patent, including any extensions and pediatric exclusivities thereof, absent a license agreement or other authorization by Plaintiffs, unless all of the claims of the ‘983 Patent, the ‘572 Patent, the ‘351 Patent, and the ‘239 Patent are found invalid or unenforceable by a court decision 2. Sun, its officers, agents, servants, employees, and affiliates who receive actual 4. 5. from which no appeal has been or can be taken, other than a petition for a writ of certiorari to the U.S. Supreme Court. Plaintiffs and Sun each expressly waive any right to appeal or otherwise move for relief from this Stipulation And Order. This Court retains jurisdiction over Plaintiffs and Sun for purposes of enforcing this Stipulation And Order. This Stipulation And Order shall finally resolve the Action between Plaintiffs and 6. Sun. This Stipulation And Order is without prejudice to any claim, defense, or counterclaim in any possible future action between Sun and any of the Plaintiffs regarding any of the ‘983 Patent, the ‘572 Patent, the ‘351 Patent, and the ‘239 Patent, and a product other than generic elagolix sodium oral tablet products (eq. 150 mg base, eq. 200 mg base) described by ANDA 215804. The Clerk of the Court is directed to enter this Stipulation And Order forthwith in the Action”
Source: PACER Docket, Case 1:23-cv-00684, Delaware District Court

The consent order language is precise and consequential: infringement under § 271(e)(2)(A) is formally adjudged — not merely stipulated as a settlement — meaning the record reflects a court judgment of technical infringement. The injunction’s conditionality (lifting only upon final invalidity of all claims of all four patents) sets an exceptionally high threshold for Sun to escape the block. The mutual waiver of appeal rights and the court’s retained jurisdiction for enforcement purposes indicate this is a final, binding resolution, not a settlement agreement dressed as a court order.

PACER case 1:23-cv-00684 · Public docket record Explore in Eureka ↗
Patent at issue

US11542239B2 — Elagolix sodium compositions and manufacturing processes

Publication No.US11542239B2
Application No.US16/519443
Patent details
ProductElagolix sodium oral tablet compositions and pharmaceutical processes
Cited in actionJune 23, 2023

US11542239B2 (application no. US16/519443) is one of four patents that formed the basis of the consent injunction in this case, covering elagolix sodium compositions and associated manufacturing processes. Elagolix is a non-peptide GnRH receptor antagonist approved by the FDA for management of endometriosis-associated pain (Orilissa®) and uterine fibroid bleeding (Oriahnn®). Patents in this family typically claim specific solid oral dosage form compositions, polymorphic forms, and process steps that define the commercial product and constrain generic replication.

The strategic significance of this patent and its co-asserted siblings (ʼ983, ʼ572, ʼ351) lies in AbbVie’s use of a layered portfolio to create overlapping exclusivity. Even if a generic manufacturer successfully invalidates one patent, the remaining patents continue to support the injunction. For competitors developing elagolix generics or next-generation GnRH antagonists, this portfolio architecture — combined with potential paediatric exclusivity extensions — substantially extends the effective exclusivity window beyond the initial patent expiry date and warrants careful FTO clearance work.

Patent data sourced from USPTO via PatSnap Eureka patent database Search patent records in Eureka ↗
Freedom to operate

Should your team run an FTO against US11542239B2 and the elagolix patent cluster?

Any company developing a generic, biosimilar, or follow-on GnRH antagonist product — particularly oral solid dosage forms targeting endometriosis or uterine fibroids — should conduct a comprehensive FTO analysis against the full elagolix patent cluster. The four injunction patents (ʼ983, ʼ572, ʼ351, ʼ239) plus the two retained patents (ʼ927, ʼ551) collectively cover compositions, formulations, processes, and potentially methods of use. A product-only FTO will be insufficient — process claims and polymorph claims must also be cleared.

PatSnap Eureka’s FTO Search Agent can map the full claim scope of each patent in AbbVie’s elagolix portfolio, identify prosecution history estoppel, surface relevant prior art for invalidity assessment, and flag any continuation or divisional applications that may extend coverage. For ANDA filers, regulatory exclusivity timelines can be overlaid with patent expiry data to model the earliest risk-free entry date — helping BD and R&D teams make informed go/no-go decisions before committing to costly formulation development.

PatSnap Eureka FTO Search

Run a freedom-to-operate analysis on US11542239B2 to assess your product’s exposure

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Related litigation

Similar Hatch-Waxman ANDA patent cases in Delaware District Court

Explore comparable § 271(e)(2)(A) ANDA infringement actions involving pharmaceutical composition patents litigated in the District of Delaware.

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Strategic implications

What this case signals for the branded pharmaceutical IP landscape

AbbVie’s rapid resolution of a six-patent ANDA suit via consent injunction is a textbook example of Hatch-Waxman portfolio enforcement strategy.

Consent orders are a powerful tool for brand pharma to lock in exclusivity fast

By resolving the suit in under 365 days with a stipulated consent order, AbbVie avoided the cost and uncertainty of a full Hatch-Waxman trial while securing an injunction with the same legal force as a litigated judgment. Companies holding layered pharmaceutical patent portfolios should model this approach when negotiating ANDA settlements — particularly where the generic filer faces a multi-patent invalidity challenge.

The four-patent injunction bar is deliberately high — all claims must fall to lift it

The consent order requires that all claims of all four injunction patents be declared invalid or unenforceable before Sun can launch. This is structurally different from a single-patent case. Patent challengers facing similar multi-patent consent orders should assess IPR petition strategy across every asserted patent simultaneously, as a partial invalidity finding provides no relief from the injunction.

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Unlock full elagolix patent portfolio strategy and ANDA litigation risk analysis for the branded pharma sector in Delaware District Court.
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Frequently asked questions

AbbVie v Sun — key questions answered

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Monitor the elagolix patent estate and generic entry risk in real time

The four-patent consent injunction in this case makes FTO clearance and patent expiry tracking essential for any company in the GnRH antagonist space. Use PatSnap Eureka to run live FTO searches and set alerts on AbbVie’s elagolix portfolio.

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