Celgene v. Sandoz: Pomalyst Consent Judgment in 25 Days
Celgene Corporation filed suit against Sandoz Inc. in the District of New Jersey asserting three pomalidomide patents covering its Pomalyst® drug. The parties resolved the ANDA infringement action by consent judgment and permanent injunction in just 25 days — enjoining Sandoz from launching its generic product until all three patents expire.
Celgene secures pomalidomide injunction via rapid consent judgment
On October 23, 2025, Celgene Corporation filed suit against Sandoz Inc. in the U.S. District Court for the District of New Jersey (Case No. 2:25-cv-16878), asserting infringement of three patents — US8,828,427, US9,993,467, and US10,555,939 — covering its pomalidomide drug product Pomalyst®. The action was triggered by Sandoz’s Abbreviated New Drug Application No. 220741, seeking FDA approval for generic pomalidomide capsules in 1 mg, 2 mg, 3 mg, and 4 mg strengths.
The case closed on November 17, 2025 — just 25 days after filing — through a consent judgment and permanent injunction stipulated by both parties. Under the consent judgment, Sandoz and its successors are enjoined from making, selling, offering for sale, importing, or distributing the ANDA product in the United States until the patents-in-suit expire. All claims and counterclaims were dismissed with prejudice and without costs or attorneys’ fees to either side.
A 25-day resolution is exceptionally fast even by ANDA litigation standards, suggesting the parties had reached a substantive commercial agreement prior to or immediately following filing. The public record does not disclose any licensing terms, market entry dates, or royalty arrangements, which are typically contained in a separate confidential settlement agreement. Sandoz retains the right to maintain its Paragraph IV certification and to engage in activities permitted under 35 U.S.C. § 271(e)(1), suggesting future litigation options are preserved for different circumstances.
Filing to Consent Judgment in 25 days
25 days — well below the typical 2–4 year ANDA litigation timeline, suggesting early negotiated resolution
Consent judgment entered: what the permanent injunction means for both parties
Consent judgment operates as a final binding order, not a settlement agreement
A consent judgment is a court-entered order — not merely a private contract — meaning it carries contempt enforcement power. Here, Celgene can seek court enforcement if Sandoz violates the injunction without needing to re-litigate infringement. The judgment explicitly preserves the court’s jurisdiction for enforcement. All claims were dismissed with prejudice, extinguishing any invalidity or non-infringement counterclaims Sandoz may have filed or intended to file.
Dismissed with prejudiceCelgene secures market exclusivity for Pomalyst® through patent expiry
The injunction prevents Sandoz from launching any pomalidomide product referencing NDA 204026 in the U.S. until all three patents expire. This preserves Celgene’s revenue stream from Pomalyst® — a multiple myeloma treatment — without the cost and uncertainty of full ANDA litigation. The with-prejudice dismissal also forecloses Sandoz from re-raising the same invalidity arguments in future proceedings based on the same patents and product.
Exclusivity preservedSandoz blocked from launch but retains key regulatory and research rights
While enjoined from commercial launch, Sandoz preserves meaningful future optionality. The judgment expressly does not prohibit Sandoz from maintaining its Paragraph IV certification or engaging in research and development activities permitted under 35 U.S.C. § 271(e)(1). The FDA is also explicitly not restricted from approving ANDA No. 220741 — meaning approval may be secured now, with commercial launch deferred until patent expiry.
Launch deferred, ANDA intactRapid resolution signals undisclosed commercial terms likely exist
A 25-day case lifecycle is consistent with parties who reached a substantive deal — potentially including a negotiated market entry date — before or immediately after filing. The public record is silent on any licensing, royalty, or authorised generic arrangement. Competitors watching the pomalidomide space and any other ANDA filers referencing NDA 204026 should note that Sandoz’s Paragraph IV certification survives, potentially triggering further regulatory and IP dynamics under the Hatch-Waxman framework.
Undisclosed deal likelyFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Celgene, Corp. | Company | Pharmaceutical innovator — holder of US10,555,939, US8,828,427, and US9,993,467 covering Pomalyst®Search in Eureka ↗ |
| Defendant | Sandoz, Inc. | Company | Generic pharmaceutical company seeking FDA approval for pomalidomide capsules via ANDA No. 220741Search in Eureka ↗ |
| Plaintiff counsel | Alexander Lee Callo | Attorney | Counsel for Celgene, Corp.Search in Eureka ↗ |
| Plaintiff counsel | Charles Michael Lizza | Attorney | Counsel for Celgene, Corp.Search in Eureka ↗ |
| Plaintiff counsel | Sarah Ann Sullvian | Attorney | Counsel for Celgene, Corp.Search in Eureka ↗ |
| Plaintiff law firm | Saul Ewing LLP | Law Firm | Representing Celgene, Corp.Search in Eureka ↗ |
| Defendant counsel | Eric I. Abraham | Attorney | Counsel for Sandoz, Inc.Search in Eureka ↗ |
| Defendant counsel | Kristine L. Butler | Attorney | Counsel for Sandoz, Inc.Search in Eureka ↗ |
| Defendant law firm | Hill Wallack LLP | Law Firm | Representing Sandoz, Inc.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | New Jersey District CourtSearch in Eureka ↗ |
Official order — verbatim text
The consent judgment is a stipulated court order, not a unilateral ruling — both parties agreed to its terms, which the court entered as a binding decree. The permanent injunction is framed in broad terms, covering all U.S. territories and reaching third parties acting on Sandoz’s behalf. Notably, the judgment is deliberately calibrated: it enjoins commercial activity but expressly preserves Sandoz’s Paragraph IV certification and § 271(e)(1) research rights, suggesting the resolution was negotiated to balance Celgene’s exclusivity interests against Sandoz’s future commercial positioning in the pomalidomide market.
US8,828,427; US9,993,467; US10,555,939 — pomalidomide formulation and treatment patents
The three patents-in-suit — US8,828,427, US9,993,467, and US10,555,939 — cover pomalidomide, an immunomodulatory drug approved for the treatment of multiple myeloma under the brand name Pomalyst®. The patents span formulation, composition, and methods-of-treatment claims, creating a layered exclusivity structure around the reference NDA 204026. The application dates span from 2010 through 2018, reflecting a strategy of building patent term extensions across successive innovations in the pomalidomide product lifecycle.
Pomalidomide is a successor to thalidomide and lenalidomide in the IMiD (immunomodulatory imide drug) class and commands significant commercial value in the multiple myeloma treatment space. Celgene’s three-patent portfolio creates overlapping protection that would require a generic challenger to overcome all three patents — either through IPR petitions or district court invalidity arguments — before achieving a clear path to commercialisation. The survival of all three patents unchallenged on the merits in this case strengthens Celgene’s enforcement posture against any future ANDA filer referencing NDA 204026.
Should your team run an FTO against the Pomalyst® pomalidomide patent portfolio?
Any pharmaceutical company developing a pomalidomide-containing product, biosimilar-adjacent IMiD candidate, or generic formulation referencing NDA 204026 should treat these three patents as active enforcement risks. The consent judgment confirms Celgene’s willingness to litigate immediately upon ANDA filing and to secure binding injunctions before generic launch. Product teams and regulatory affairs professionals should map their formulation and dosing regimens against the claim scopes of US8,828,427, US9,993,467, and US10,555,939 before committing to an ANDA strategy.
PatSnap Eureka’s FTO Search Agent can map your pomalidomide product candidate against the full claim landscape of all three patents-in-suit, identify prosecution history estoppel, and surface prior art that could support an IPR petition. Eureka also tracks related family members and continuation applications that may extend protection beyond the current patents, giving your IP and R&D teams a complete picture of the exclusivity runway before you file.
Run a freedom-to-operate analysis on US10555939B2 to assess your product’s exposure
Run FTO in Eureka →Similar pomalidomide ANDA patent cases in U.S. district courts
Other Hatch-Waxman ANDA infringement actions involving pomalidomide patents and NDA 204026 decided in federal district courts across the U.S.
What this case signals for the pharmaceutical ANDA IP landscape
This consent judgment illustrates how branded pharma uses swift ANDA litigation to lock in injunctive relief before generic market entry.
ANDA filers face immediate injunction risk on Day 1 of litigation
Celgene obtained a permanent injunction within 25 days of filing. Generic manufacturers filing ANDAs against multi-patent branded drugs should anticipate rapid litigation and consider whether early negotiation — including authorised generic or market entry date agreements — is commercially preferable to full patent litigation.
With-prejudice dismissal closes invalidity arguments for this ANDA product
Sandoz’s invalidity and non-infringement counterclaims are extinguished with prejudice for this specific product and ANDA. Any future generic entrant referencing NDA 204026 will need to independently establish invalidity of the three pomalidomide patents, without relying on Sandoz’s dismissed positions in this action.
Celgene v Sandoz — key questions answered
The consent judgment, entered November 17, 2025, permanently enjoins Sandoz from making, selling, or importing its ANDA No. 220741 pomalidomide product in the U.S. until expiry of US8,828,427, US9,993,467, and US10,555,939. All claims were dismissed with prejudice and without costs to either party.
Celgene asserted three U.S. patents: US8,828,427, US9,993,467, and US10,555,939. All three cover pomalidomide formulations and methods of treatment relating to Pomalyst® (NDA 204026) and are collectively referred to as the Patents-in-Suit in the consent judgment.
Sandoz is enjoined from commercial launch until the three patents expire. However, the FDA is not restricted from approving ANDA No. 220741, and Sandoz retains its Paragraph IV certification and research rights under 35 U.S.C. § 271(e)(1). A launch may proceed upon patent expiry, subject to any further regulatory or commercial arrangements not disclosed in the public record.
The with-prejudice dismissal extinguishes Sandoz’s own invalidity and non-infringement claims for this ANDA product. It does not directly bind other ANDA filers, who would need to independently challenge the patents. However, the absence of any merits ruling means no invalidity findings are available for other challengers to rely upon from this proceeding.
A 25-day resolution is consistent with parties who reached a substantive commercial agreement before or immediately after filing. The public record does not disclose any licensing, authorised generic, or market entry date terms. Such agreements are typically contained in a separate confidential settlement document that is not filed with the court.
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