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AbbVie v. Teva: Elagolix Patent Infringement Case (ANDA 217650) | PatSnap
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Case ID1:23-cv-00133
FiledFeb 2023
ClosedJan 2024
Patent Litigation

AbbVie v. Teva: Teva Admits Infringement of Elagolix Patents, Accepts Injunction

AbbVie brought a Hatch-Waxman infringement action against Teva in Delaware over two patents covering elagolix sodium co-packaged capsules used to treat heavy menstrual bleeding. Teva admitted both patents are valid, enforceable, and infringed — and was permanently enjoined from commercialising its ANDA 217650 product for the life of either patent. The case resolved in 333 days without a full trial.

Resolution time
333days
333 days — resolved before trial in under 12 months
Patents asserted
2
US11045470 and US10881659 — elagolix sodium co-pack, HMB treatment
Outcome
Dismissed without Prejudice
Teva admitted infringement; permanent injunction entered by consent order
Cost ruling
Each bears own
No costs award specified — parties waived appeal rights under the stipulation
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

Teva’s ANDA admission hands AbbVie a clean elagolix patent win

Filed on 2 February 2023 in the District of Delaware before Judge Richard G. Andrews, this Hatch-Waxman action saw AbbVie assert US Patent Nos. 10,881,659 and 11,045,470 against Teva’s ANDA 217650 — an application for a generic version of elagolix sodium, estradiol, and norethindrone acetate co-packaged capsules, sold under the Oriahnn brand for heavy menstrual bleeding. The filing of an ANDA referencing a listed patent constitutes a technical act of infringement under 35 U.S.C. § 271(e)(2)(A), which triggered AbbVie’s right to sue and a statutory 30-month stay on FDA approval.

The case closed on 2 January 2024 via a consent stipulation and order. Critically, Teva admitted that both the ‘659 and ‘470 patents are valid, enforceable, and would be infringed by the commercial manufacture, use, or sale of its ANDA product. The court then entered a permanent injunction barring Teva — and those acting in concert with it — from commercialising the ANDA 217650 product for the entire remaining life of both patents, including any extensions or pediatric exclusivities, absent an AbbVie licence. Other claims, counterclaims, and defences were dismissed without prejudice.

Resolution in under a year, without trial or claim construction proceedings on the public record, suggests the parties reached an agreed position — possibly including an undisclosed licence or market entry date — before litigation costs escalated. The without-prejudice dismissal of ancillary claims preserves both parties’ positions on any future disputes involving the same patents and a different product. The public record does not disclose whether any licence agreement, settlement payment, or authorised generic arrangement was agreed as part of the broader resolution.

Case at a glance
Case no.1:23-cv-00133
PlaintiffAbbVie, Inc.
CourtDelaware
JudgeRichard G. Andrews
FiledFebruary 3, 2023
ClosedJanuary 2, 2024
Duration333 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 voluntary dismissal in 333 days

333 days — resolved before trial in under 12 months

Case timeline: Complaint filed May 13 2025, JUL–AUG — 333 days total Horizontal timeline showing the three key events in AbbVie, Inc. v Teva Pharmaceutical Industries, Ltd. from filing to voluntary dismissal. Source: PACER, Delaware District Court. FEB 3 2023 Complaint filed JUL–AUG 2023 Pre-trial proceedings JAN 2 2024 Dismissed without prejudice 333 DAYS TOTAL
Court ruling

Consent order: Teva admits infringement and accepts permanent injunction

Legal mechanism

What a consent stipulation and order means

A consent stipulation and order is a binding court judgment agreed by both parties. It carries the same legal force as a litigated judgment. Here, it means Teva’s admission of infringement is on the permanent public record, and the injunction is enforceable by the court for the life of both patents. Both parties also waived any right to appeal or seek relief from its terms.

Binding final judgment
Scope of dismissal

Without prejudice: what remains open

Ancillary claims, counterclaims, and defences were dismissed without prejudice — meaning Teva retains the right to challenge validity or non-infringement in a future action involving a different product. However, Teva’s explicit admission that the ‘659 and ‘470 patents are valid and enforceable in this action could carry persuasive weight in any future dispute, even if it is not technically preclusive on different product facts.

Future disputes preserved
Injunction scope

Permanent injunction tied to full patent life

The injunction extends to the life of either patent, including any extensions (e.g., patent term extensions under 35 U.S.C. § 156) and any pediatric exclusivity periods. This means Teva cannot launch its ANDA 217650 product until the last of those protections expires — unless it secures an explicit licence from AbbVie. The injunction binds Teva’s officers, agents, and all persons acting in concert.

Covers extensions & exclusivity
Hatch-Waxman framework

Why ANDA filing itself triggers infringement

Under 35 U.S.C. § 271(e)(2)(A), submitting an ANDA referencing a listed patent is itself a statutory act of infringement, even before any product is manufactured or sold. This Hatch-Waxman mechanism exists to allow brand and generic companies to resolve patent disputes before market entry, giving patent holders like AbbVie the ability to obtain injunctive protection without waiting for actual commercial launch.

§ 271(e)(2)(A) ANDA mechanism
Legal analysis based on PACER docket records for case 1:23-cv-00133 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffAbbVie, Inc.CompanyAbbVie, Inc. — biopharmaceutical company; holder of US11045470 and US10881659Search in Eureka ↗
DefendantTeva Pharmaceutical Industries, Ltd.CompanyTeva Pharmaceutical Industries Ltd. — global generic drug manufacturer, ANDA 217650 filerSearch 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 ↗
Defendant counselKaren Elizabeth KellerAttorneyCounsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗
Defendant counselNathan Roger HoeschenAttorneyCounsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗
Presiding judgeJudge Richard G. AndrewsChief JudgeDelaware District Court — Chief JudgeSearch in Eureka ↗
Official verdict

Stipulation of dismissal — official text

“The Court, upon the consent and request of Plaintiff AbbVie Inc. (“AbbVie”) and Defendant Teva Pharmaceuticals, Inc. (“Teva”), hereby acknowledges the following Stipulation and issues the following Order in the above-captioned action. STIPULATION 1. This Court has subject matter jurisdiction over this patent infringement action (the “Action”) and personal jurisdiction over AbbVie and Teva for purposes of the Action. 2. Venue is proper in this Court as to AbbVie and Teva for the Action. 3. AbbVie has asserted claims against Teva for infringement of U.S. Patent Nos. 10,881,659 (the “’659 Patent) and 11,045,470 (the “’470 Patent”) in connection with Teva’s submission of Abbreviated New Drug Application (“ANDA”) 217650 directed to generic elagolix sodium, estradiol, norethindrone acetate (eq. 300 mg base, 1 mg, 0.5 mg); elagolix sodium (eq. 300 mg base) co-packaged capsules to the U.S. Food and Drug Administration (“FDA”). 4. Teva admits that the ’659 Patent and the ’470 Patent are enforceable, valid, and would be infringed by the commercial manufacture, use, and/or sale within the United States of the generic elagolix sodium, estradiol, norethindrone acetate (eq. 300 mg base, 1 mg, 0.5 mg); elagolix sodium (eq. 300 mg base) co-packaged capsules that are the subject of Teva’s ANDA 217650. 5. Teva admits that the submission of ANDA 217650 to the FDA for purposes of obtaining regulatory approval to engage in the commercial manufacture, use, and/or sale within the United States of the generic elagolix sodium, estradiol, norethindrone acetate (eq. 300 mg base, 1 mg, 0.5 mg); elagolix sodium (eq. 300 mg base) co-packaged capsules was an act of infringement of each of the ’659 Patent and the ’470 Patent under 35 U.S.C. § 271(e)(2)(A). 6. The parties agree that all other claims, counterclaims, and defenses asserted against each other in AbbVie’s and Teva’s pleadings in the Action, including the allegations and averments contained therein, should be dismissed, without prejudice. ORDER Accordingly, pursuant to the above Stipulation, and upon the consent and request of AbbVie and Teva, IT IS HEREBY ORDERED, ADJUDGED AND DECREED THAT: 1. The filing of ANDA 217650 was an act of infringement of each of the ’470 Patent and the ’659 Patent under 35 U.S.C. § 271(e)(2)(A). 2. All other claims, counterclaims, and defenses asserted by the parties against each other in AbbVie’s and Teva’s pleadings in the Action, including the allegations and averments contained therein are hereby dismissed, without prejudice. 3. Teva, its officers, agents, servants, employees, and attorneys, and all other persons in active concert or participation with any of them who receive actual 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, estradiol, norethindrone acetate (eq. 300 mg base, 1 mg, 0.5 mg); elagolix sodium (eq. 300 mg base) co-packaged capsule products described by ANDA 217650 during the life of either of the ’470 Patent and the ’659 Patent, including any extensions and pediatric exclusivities thereof, absent a license agreement or other authorization by AbbVie. 4. AbbVie and Teva each expressly waive any right to appeal or otherwise move for relief from this Stipulation And Order. 5. This Court retains jurisdiction over AbbVie and Teva for purposes of enforcing this Stipulation And Order. 6. This Stipulation And Order shall finally resolve the Action between the Parties. 7. This Stipulation And Order is without prejudice to any claim, defense, or counterclaim in any possible future action between Teva and AbbVie regarding either of the ’470 Patent and the ’659 Patent and a product other than the generic elagolix sodium, estradiol, norethindrone acetate (eq. 300 mg base, 1 mg, 0.5 mg); elagolix sodium (eq. 300 mg base) copackaged capsule products described by ANDA 217650. 8. The Clerk of the Court is directed to enter this Stipulation And Order forthwith in the Action.”
Source: PACER Docket, Case 1:23-cv-00133, Delaware District Court · Filed January 2, 2024

The consent order is structured as a full final resolution — not a partial settlement. Teva’s admissions on validity, enforceability, and infringement are unqualified and on the public record, which is unusual in Hatch-Waxman litigation where defendants typically preserve invalidity arguments. The permanent injunction covering extensions and pediatric exclusivities closes off near-term generic entry via this ANDA. However, the without-prejudice language on ancillary claims, and the carve-out for future actions on different products, means the parties have deliberately preserved tactical flexibility beyond this specific dispute.

PACER case 1:23-cv-00133 · Public docket record Explore in Eureka ↗
Patent at issue

US11045470 & US10881659 — Elagolix sodium co-pack formulations

Publication No.US11045470B2
Application No.US16/355359
Patent details
AssigneeAbbVie, Inc.
ProductUS11045470 — elagolix sodium co-pack formulation methods
Publication typeB2 — grant (with prior publication)
Cited in actionFebruary 3, 2023

Publication No.US10881659B2
Application No.US14/211096
Patent details
AssigneeAbbVie, Inc.
ProductUS10881659 — elagolix sodium co-pack formulation methods
Publication typeB2 — grant (with prior publication)
Cited in actionFebruary 3, 2023

US10,881,659 (application no. US14/211096) and US11,045,470 (application no. US16/355359) both protect aspects of AbbVie’s elagolix sodium franchise — specifically the co-packaged formulation combining elagolix sodium (eq. 300 mg base), estradiol (1 mg), and norethindrone acetate (0.5 mg) capsules used in the treatment of heavy menstrual bleeding associated with uterine fibroids. The application lineage of the ‘659 patent predates the ‘470 patent, with the ‘470 patent’s application number suggesting a continuation or related filing strategy to extend and refine the protected claim scope across the product lifecycle.

Elagolix (sold as Oriahnn by AbbVie) is a GnRH receptor antagonist, and the co-packaged formulation with add-back hormone therapy represents a clinically and commercially distinctive product design. The dual-patent assertion strategy — asserting two related patents simultaneously against a single ANDA — is consistent with AbbVie’s broader approach to building layered patent protection around its key franchises. For competitors developing GnRH antagonist products or seeking to file ANDAs in women’s health, this outcome demonstrates that AbbVie is prepared to enforce both formulation and method patents aggressively and secure injunctions that cover the full statutory protection period.

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Freedom to operate

Should you run an FTO analysis against US10881659 and US11045470?

Any company developing GnRH antagonist formulations, elagolix sodium combination products, or ANDA applications targeting heavy menstrual bleeding indications should treat these two patents as live blocking risks. The consent order confirms they are valid, enforceable, and actively asserted. R&D and regulatory teams considering formulations involving elagolix sodium — whether in co-pack or standalone configurations — need claim-level FTO analysis before committing to development or ANDA filing costs.

PatSnap Eureka’s FTO Search Agent lets you map claims across US10881659 and US11045470 against your specific product design, identifying freedom corridors or design-around opportunities before litigation risk materialises. Eureka’s claim monitoring tools can also alert your team if AbbVie files continuation applications that extend claim coverage beyond the two patents already asserted — a common lifecycle management strategy in pharmaceutical IP.

PatSnap Eureka FTO Search

Run a freedom-to-operate analysis on US11045470B2 to assess your product’s exposure

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Strategic implications

What this case signals for the women’s health and ANDA litigation landscape

A swift admission and permanent injunction in a Hatch-Waxman case carries outsized signals for how AbbVie enforces its elagolix franchise.

AbbVie’s elagolix patent position proved strong enough to secure admission

Teva’s unconditional admission that both patents are valid, enforceable, and infringed — without any invalidity counterclaim surviving — suggests AbbVie’s patent portfolio around elagolix sodium formulations is robust. Companies considering ANDA challenges to Oriahnn-related patents should expect aggressive enforcement and well-prepared claim sets.

Early resolution in ANDA cases often signals an undisclosed licence

Consent orders in Hatch-Waxman litigation that arrive within 12 months, without public invalidity arguments, are frequently accompanied by authorised generic agreements or future market-entry licences. The public record here is silent on any such arrangement, but this pattern is well-established in the sector. Monitoring future FDA Orange Book listings and authorised generic designations for ANDA 217650 may reveal undisclosed terms.

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PTE-adjusted expiry datesTeva ANDA 217650 future riskAbbVie enforcement patterns
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Frequently asked questions

AbbVie v Teva — key questions answered

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Run your own elagolix patent FTO or ANDA risk analysis

Use PatSnap Eureka to map claim coverage across US10881659 and US11045470 before filing. Monitor AbbVie continuations and track enforcement activity across the Oriahnn patent family in real time.

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