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Celgene v. Teva & Natco: Onureg Azacitidine Patent Consent Judgment | PatSnap
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Case ID1:23-cv-01008
FiledSep 2023
ClosedMay 2024
Patent Litigation

Celgene & BMS v. Teva & Natco: Onureg® Azacitidine Consent Judgment (259 Days)

Celgene, Celgene International, and Bristol-Myers Squibb secured a consent judgment and injunction against Natco Pharma over two patents protecting Onureg® oral azacitidine tablets, blocking Natco’s ANDA product until both patents expire. The case resolved in 259 days without costs or attorneys’ fees to either side.

Resolution time
259days
259 days — faster than median Hatch-Waxman ANDA litigation in Delaware
Patents asserted
2
US11571436B2 and 1 further patent asserted (US8846628B2) — oral azacitidine tablet formulations
Outcome
Consent Judgment
Injunction entered by stipulation; Natco enjoined until expiry of both patents-in-suit
Cost ruling
No Costs Awarded
All claims dismissed with prejudice; no costs, disbursements, or attorneys’ fees to any party
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

BMS/Celgene Lock Out Natco’s Generic Azacitidine via Stipulated Injunction

Filed on 13 September 2023 in the District of Delaware before Judge Jennifer L. Hall, this Hatch-Waxman action was brought by Celgene Corporation, Celgene International SARL, and Bristol-Myers Squibb Company against Teva Pharmaceutical Industries and Natco Pharma Limited. The suit asserted US Patent Nos. 11,571,436 and 8,846,628, both covering oral azacitidine tablet formulations sold under the Onureg® brand, a maintenance therapy approved for acute myeloid leukemia. The trigger was Natco’s ANDA No. 218696 seeking approval to market 200 mg and 300 mg azacitidine tablets in the United States.

The case closed on 29 May 2024 via a consent judgment — a stipulated resolution in which Natco agreed to entry of a permanent injunction without admitting infringement or invalidity. Natco is barred from making, selling, importing, or distributing its ANDA product in the US until expiration of both patents-in-suit. All claims and counterclaims were dismissed with prejudice, and no costs or fees were assessed. Importantly, the consent judgment explicitly preserves Natco’s right to maintain its Paragraph IV certification and to conduct activities permitted under 35 U.S.C. § 271(e)(1), leaving open future challenge pathways.

Resolution in 259 days — well within a typical 30-month Hatch-Waxman stay window — suggests the parties reached commercial alignment before any substantive patent merits were adjudicated. The public record does not disclose whether a licensing arrangement or market entry date was negotiated separately. The injunction’s explicit carve-out preserving FDA approval of the ANDA and Natco’s Paragraph IV rights is a notable drafting choice, consistent with preserving optionality for post-expiry or post-IPR entry scenarios.

Case at a glance
Case no.1:23-cv-01008
CourtDelaware
JudgeJennifer L. Hall
FiledSeptember 13, 2023
ClosedMay 29, 2024
Duration259 days
OutcomeConsent Judgment
Verdict causeInfringement Action
BasisConsent Judgment
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 Consent Judgment in 259 days

259 days — faster than median Hatch-Waxman ANDA litigation in Delaware

Case timeline: Complaint filed SEP 13 2023, JAN–FEB — 259 days total Horizontal timeline showing the three key events in Celgene, Corp. v Teva Pharmaceutical Industries, Ltd. from filing to resolution. Source: PACER, Delaware District Court. SEP 13 2023 Complaint filed Pre-trial proceedings MAY 29 2024 Consent Judgment 259 DAYS TOTAL
Dismissal terms

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

Legal mechanism

A consent judgment is a court-entered injunction by agreement

A consent judgment differs from a litigated ruling: both parties stipulate to its terms, and the court enters it as an enforceable order. Here, Natco agreed to an injunction blocking its ANDA product until patent expiry without any finding of infringement or invalidity. All claims were dismissed with prejudice — meaning neither party can re-litigate the same claims in a new action — but the underlying patents remain unchallenged on the merits.

Dismissed with prejudice
Patent holder outcome

Plaintiffs secure patent exclusivity through expiry without trial risk

BMS and Celgene obtained the outcome that matters commercially: a court-enforced injunction that prevents Natco’s generic azacitidine product from entering the US market until both patents expire. By resolving pre-trial, they avoided the risk of an invalidity or non-infringement finding on US11571436B2 or US8846628B2. Compliance is enforceable by plaintiffs and their successors, providing durable protection for Onureg® revenues during the remaining patent term.

Injunction until patent expiry
Generic challenger outcome

Natco enjoined but retains future challenge rights and ANDA approval path

Natco cannot market its ANDA product while both patents remain in force, but the consent judgment was carefully drafted to preserve key rights. Natco may maintain its Paragraph IV certification, allowing it to pursue future patent challenges — including via IPR — and the FDA remains free to approve ANDA No. 218696. Natco also retains safe harbour rights under 35 U.S.C. § 271(e)(1). These carve-outs suggest Natco’s litigation posture may not be permanently resolved.

Para IV & IPR rights preserved
Commercial implications

Onureg® patent barrier strengthened; AML maintenance therapy market stays protected

For the oral azacitidine and AML maintenance therapy market, this consent judgment reinforces the patent barrier around Onureg®. Other ANDA filers referencing NDA 214120 should note the injunction’s broad scope, which also bars Natco from assisting third parties in infringing the patents-in-suit. Competitors in the space should assess both patents’ expiry timelines and monitor for IPR petitions that could reopen the generic entry window ahead of schedule.

AML therapy market protected
Legal analysis based on PACER docket records for case 1:23-cv-01008 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffCelgene, Corp.CompanyPharmaceutical patent holder — BMS/Celgene, holders of US11571436B2 and US8846628B2 covering Onureg® oral azacitidineSearch in Eureka ↗
Co-PlaintiffBristol‑Myers Squibb CompanyCompanySearch in Eureka ↗
Co-PlaintiffCelgene International, SARLIndividualSearch in Eureka ↗
DefendantTeva Pharmaceutical Industries, Ltd.CompanyGeneric pharmaceutical manufacturer — Natco Pharma seeking US approval for azacitidine tablets via ANDA 218696Search in Eureka ↗
Co-DefendantNatco Pharma LimitedIndividualSearch in Eureka ↗
Plaintiff counselAmy K. WigmoreAttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff counselAndrew J. DanfordAttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff counselBrian E. FarnanAttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff counselDavid MlaverAttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff counselGerard A. SalvatoreAttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff counselHeather M. PetruzziAttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff counselJoseph J. Farnan , Jr.AttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff counselLi-tsung A. ChenAttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff counselMichael J. FarnanAttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff counselNora Q.E. PassamaneckAttorneyCounsel for Celgene, Corp.Search in Eureka ↗
Plaintiff law firmFarnan LLPLaw FirmRepresenting Celgene, Corp.Search in Eureka ↗
Defendant counselElise M. LecroneAttorneyCounsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗
Defendant counselGeorge C. LombardiAttorneyCounsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗
Defendant counselIvan M. PoullaosAttorneyCounsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗
Defendant counselKaren Elizabeth KellerAttorneyCounsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗
Defendant counselKevin J. BoyleAttorneyCounsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗
Defendant counselNathan Roger HoeschenAttorneyCounsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗
Defendant law firmShaw Keller LLPLaw FirmRepresenting Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗
Presiding judgeJudge Jennifer L. HallJudgeDelaware District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“Plaintiffs Celgene Corporation, Celgene International Sárl, and Bristol-Myers Squibb Company (collectively, “Plaintiffs”), and Defendant Natco Pharma Ltd. (“Natco”), the parties in the above-captioned action, hereby stipulate and consent to entry of judgment and an injunction in this action as follows: IT IS this ______ day of ____________, 2024: ORDERED, ADJUDGED, AND DECREED as follows: 29th May Case 1:23-cv-01008-JLH Document 34 Filed 05/29/24 Page 1 of 4 PageID #: 369 1. This Court has jurisdiction over the subject matter of the above action and has personal jurisdiction over the parties for purposes of this action only, including as set forth below in Paragraph 6 of this Consent Judgment. 2. As used in this Consent Judgment, the term “Natco ANDA Product” shall mean 200 mg and 300 mg azacitidine tablets manufactured, imported, sold, offered for sale, marketed, or distributed pursuant to Abbreviated New Drug Application No. 218696 in or for the United States of America, including its territories, possessions, and the Commonwealth of Puerto Rico. 3. As used in this Consent Judgment, the term “Patents-in-Suit” shall mean U.S. Patent Nos. 8,846,628 and 11,571,436. 4. Until expiration of the Patents-in-Suit, Natco, including any of its successors and assigns, is enjoined from infringing the Patents-in-Suit, on its own part or through any third party on its behalf, by making, having made, using, selling, offering to sell, importing, or distributing of the Natco ANDA Product in or for the United States of America, including its territories, possessions, and the Commonwealth of Puerto Rico, unless and to the extent otherwise specifically authorized by Plaintiffs, and is further enjoined from assisting or cooperating with any third parties in connection with any infringement of the Patents-in-Suit by any such third parties in connection with making, having made, using, selling, offering to sell, importing, or distributing of any azacitidine-containing drug product that references New Drug Application 214120 in or for the United States of America, including its territories, possessions, and the Commonwealth of Puerto Rico, unless and to the extent otherwise specifically authorized by Plaintiffs. Case 1:23-cv-01008-JLH Document 34 Filed 05/29/24 Page 2 of 4 PageID #: 370 5. Compliance with this Consent Judgment may be enforced by Plaintiffs and its respective successors in interest or assigns. 6. This Court retains jurisdiction to enforce the terms of this Consent Judgment and to enforce and resolve any disputes related thereto. 7. All claims, counterclaims, affirmative defenses, motions and demands in this action that are hereby dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. 8. Nothing herein prohibits or is intended to prohibit Natco from maintaining any “Paragraph IV Certification” pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) or pursuant to 21 C.F.R. § 314.94(a)(12) with respect to the Patents-in-Suit or any other patent. 9. Nothing herein restricts or is intended to restrict the U.S. Food and Drug Administration from approving Abbreviated New Drug Application No. 218696 or the Natco ANDA Product. 10. Nothing herein prohibits or is intended to prohibit Natco from engaging in any activity permitted under 35 U.S.C. § 271(e)(1).”
Source: PACER Docket, Case 1:23-cv-01008, Delaware District Court

The consent judgment is entered by stipulation — neither party litigated to a merits determination. The injunction’s scope is broad, covering Natco’s ANDA product and any third-party assistance in connection with azacitidine products referencing NDA 214120. Critically, the dismissal with prejudice forecloses re-litigation of these specific claims, but the express preservation of Paragraph IV and § 271(e)(1) rights signals that both patents remain potentially vulnerable to post-grant administrative challenges, even as the district court litigation is permanently closed.

PACER case 1:23-cv-01008 · Public docket record Explore in Eureka ↗
Patent at issue

US11571436B2 & US8846628B2 — Oral Azacitidine Tablet Formulations (Onureg®)

Publication No.US11571436B2
Application No.US17/533033
Patent details
Productoral azacitidine tablet formulations and methods of use
Cited in actionSeptember 13, 2023

Publication No.US8846628B2
Application No.US12/466213
Patent details
Productazacitidine oral solid dosage form compositions and methods
Cited in actionSeptember 13, 2023

US11571436B2 (application no. 17/533,033) and US8846628B2 (application no. 12/466,213) are the two patents-in-suit protecting Onureg® (oral azacitidine) — a first-in-class oral hypomethylating agent approved for maintenance therapy in adult patients with AML. The patents cover formulations and methods relating to azacitidine in oral tablet form, a significant technical advance over earlier IV/subcutaneous azacitidine (Vidaza®). The earlier filing date of US8846628B2 (application 2009) reflects long-standing IP investment in this oral delivery technology, while US11571436B2 represents a later continuation capturing refined formulation claims.

These patents are commercially critical because Onureg® represents a meaningful revenue stream for BMS following the Celgene acquisition. The oral formulation patents create a high barrier for generic entry because oral bioavailability of azacitidine requires specific formulation expertise — not merely reformulating an existing IV product. Any generic manufacturer targeting this space must navigate both the formulation claims and the method-of-use claims. The consent judgment’s preservation of Natco’s Paragraph IV rights suggests these patents may face post-grant validity scrutiny, making freedom-to-operate and IPR landscape analysis essential for competitors.

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

Should you run an FTO against US11571436B2 and US8846628B2?

Any pharmaceutical company developing oral azacitidine generics or novel oral hypomethylating agents for AML or related indications should treat these two patents as high-priority FTO targets. The injunction entered in this case covers not only Natco’s specific ANDA but also any azacitidine product referencing NDA 214120 — and the carve-outs confirm BMS/Celgene will enforce. Even formulation variants that differ from Natco’s 200/300 mg tablets may fall within claim scope depending on claim construction.

PatSnap Eureka’s FTO Search Agent can map the claim boundaries of US11571436B2 and US8846628B2 against your candidate formulation, identify prosecution history estoppel that may limit claim scope, and surface any IPR petitions or ex parte reexaminations filed against these patents. Eureka can also identify the full BMS/Celgene oral azacitidine patent family to ensure no continuation claims are overlooked — a critical step before committing to an ANDA development programme.

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Related litigation

Similar Hatch-Waxman ANDA cases involving oral oncology formulation patents in Delaware

Explore related Hatch-Waxman ANDA infringement cases in the Delaware District Court involving oral oncology and hypomethylating agent formulation patents.

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Strategic implications

What this case signals for the oral oncology generic drug IP landscape

This consent judgment reinforces BMS/Celgene’s Onureg® exclusivity and sets a precedent for how branded pharma can resolve ANDA challenges efficiently.

Pre-trial consent judgments are a powerful tool for branded pharma patent protection

By securing a stipulated injunction in under 259 days, BMS and Celgene avoided trial risk while locking in patent exclusivity through expiry. For IP teams at branded pharmaceutical companies, this illustrates the value of moving assertively at the ANDA filing stage and negotiating resolution before invalidity arguments are fully developed in litigation.

Preserved Paragraph IV rights mean Natco’s challenge is deferred, not abandoned

The consent judgment’s carve-outs for Paragraph IV certification and § 271(e)(1) safe harbour activity are strategically significant. Natco retains the ability to file IPR petitions against US11571436B2 and US8846628B2 at any time. Companies relying on this injunction for market exclusivity should monitor the USPTO’s IPR docket for any post-grant challenge filings against either patent.

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Frequently asked questions

Celgene v Teva — key questions answered

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Monitor the oral azacitidine patent landscape before your next ANDA filing

This consent judgment confirms BMS and Celgene will enforce aggressively. Run a full FTO and patent term analysis on US11571436B2 and US8846628B2 in PatSnap Eureka before committing to an oral azacitidine development programme.

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