Merck v. Aurobindo: JANUMET XR® Patent Dispute Settled by Consent Judgment in 81 Days
Merck Sharp & Dohme filed suit against Aurobindo Pharma in Delaware District Court asserting US7326708B2 to block generic sitagliptin/metformin hydrochloride extended release tablets. The parties reached a negotiated settlement and stipulated to a consent judgment — including an injunction — just 81 days after filing.
Hatch-Waxman challenge to JANUMET XR® resolved before any merits ruling
On 11 April 2025, Merck Sharp & Dohme LLC filed a patent infringement action in the District of Delaware against Aurobindo Pharma, Ltd. and Aurobindo Pharma USA, Inc., asserting US7326708B2. The suit targeted Aurobindo’s ANDA for generic sitagliptin/metformin hydrochloride extended release combination tablets in 100 mg/1000 mg and 50 mg/1000 mg strengths — bioequivalent forms of Merck’s branded JANUMET XR®. Judge Colm F. Connolly presided. Merck was represented by McCarter & English LLP.
The case closed on 1 July 2025 — just 81 days after filing — via a consent judgment entered by stipulation. The parties executed two separate Settlement Agreements setting out negotiated terms, then jointly asked the court to enter both a judgment and an injunction. No trial or claim construction hearing is reflected in the public record. The injunction element is significant: it indicates Aurobindo accepted restraints on its ability to launch the generic product, at least under the agreed terms.
An 81-day resolution is notably swift for Hatch-Waxman litigation, where cases routinely run two to three years to trial. The speed, combined with the consent injunction, suggests the parties reached commercial accommodation — potentially involving a negotiated launch date — rather than a pure capitulation. The specific license terms, any royalty arrangement, and Aurobindo’s permitted entry date remain confidential under the Settlement Agreements and are not discernible from the public docket.
Filing to Consent Judgment in 81 days
81 days from filing to consent judgment — significantly faster than the median Hatch-Waxman trial
Consent judgment entered: what the settlement means for both parties
Consent judgment and injunction by stipulation
A consent judgment is a court-enforceable resolution agreed to by both parties — distinct from a voluntary dismissal. Here, the parties went further by stipulating to an injunction, giving Merck court-backed restraint on Aurobindo’s generic launch. This makes the settlement binding and judicially supervised, not merely a private agreement that could be abandoned.
Judicially enforceable settlementMerck secures injunction protecting JANUMET XR® market position
By obtaining a consent injunction, Merck achieved meaningful protection for US7326708B2 without the cost and uncertainty of full Hatch-Waxman litigation. The injunction blocks or defers Aurobindo’s generic entry on terms Merck agreed to — typically a defined launch date or licence. US7326708B2 remains unchallenged on the merits, preserving its enforceability against other potential ANDA filers.
Patent validity preservedAurobindo accepts injunction — but likely negotiated a launch date
Aurobindo’s agreement to a consent injunction suggests it did not secure an immediate right to market. However, Hatch-Waxman settlements of this type routinely include a negotiated authorised generic arrangement or a specified entry date. Aurobindo avoided the risk of a permanent injunction following a full trial, preserving the ability to enter the market on agreed terms. The confidential Settlement Agreements govern the specifics.
Entry terms undisclosedUS7326708B2 survives intact — risk for other sitagliptin ANDA filers
Because no invalidity or non-infringement ruling was issued, US7326708B2 exits this litigation with its presumption of validity fully intact. Any other ANDA filer seeking to launch a generic sitagliptin/metformin ER product faces the same patent barrier Aurobindo encountered. The consent injunction also signals Merck’s willingness to litigate aggressively and seek judicial enforcement rather than purely private resolution.
Patent barrier remains in forceFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Merck Sharp & Dohme, LLC | Company | Pharmaceutical innovator — holder of US7326708B2 covering JANUMET XR® formulationsSearch in Eureka ↗ |
| Defendant | Aurobindo Pharma, Ltd. | Company | Generic pharmaceutical manufacturer seeking ANDA approval for sitagliptin/metformin ER tabletsSearch in Eureka ↗ |
| Plaintiff counsel | Alexandra M. Joyce | Attorney | Counsel for Merck Sharp & Dohme, LLCSearch in Eureka ↗ |
| Plaintiff counsel | Daniel M. Silver | Attorney | Counsel for Merck Sharp & Dohme, LLCSearch in Eureka ↗ |
| Plaintiff law firm | McCarter & English LLP | Law Firm | Representing Merck Sharp & Dohme, LLCSearch in Eureka ↗ |
| Presiding judge | Judge Colm F. Connolly | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
The consent judgment recites that both parties ‘agreed to terms and conditions representing a negotiated settlement’ and stipulated to ‘entry of judgment and an injunction.’ This phrasing is significant: it is not a voluntary dismissal or a covenant not to sue. The court’s entry of the injunction gives Merck a judicially enforceable remedy. Because no merits finding accompanies the judgment, neither validity nor infringement of US7326708B2 was adjudicated — the patent stands on its original presumption of validity.
US7326708B2 — Sitagliptin/metformin HCl extended release oral tablet formulation
US7326708B2, filed under application number US10/874992, covers formulations at the heart of JANUMET XR® — Merck’s extended release combination tablet for type 2 diabetes management pairing sitagliptin (a DPP-4 inhibitor) with metformin hydrochloride. Extended release formulations require precise pharmaceutical engineering to control dual-active dissolution profiles, creating meaningful technical and IP barriers relative to immediate release combinations.
JANUMET XR® occupies a substantial market position in the type 2 diabetes therapeutic segment. US7326708B2 is a key exclusivity asset: any ANDA filer seeking to commercialise a bioequivalent sitagliptin/metformin ER tablet in the US must navigate this patent. The consent injunction obtained against Aurobindo confirms Merck’s active enforcement posture. Competitors in the DPP-4/biguanide combination space — including potential future ANDA filers — face a live and unchallenged patent barrier.
Should you run an FTO analysis against US7326708B2?
Any pharmaceutical manufacturer, CDMO, or formulation team developing generic or next-generation sitagliptin/metformin extended release tablets for the US market should treat US7326708B2 as a mandatory FTO checkpoint. The consent injunction in this case confirms Merck’s willingness to enforce the patent rapidly. ANDA filers, 505(b)(2) applicants, and authorised generic partners are all within the risk perimeter.
PatSnap Eureka’s FTO Search Agent can map the full claims landscape of US7326708B2 against your formulation parameters, identify relevant prior art that may support design-around strategies, and surface related Merck portfolio filings in the DPP-4 inhibitor and metformin ER space. Real-time patent status monitoring ensures you are alerted to any continuation filings or reissue proceedings that could extend the exclusivity window.
Run a freedom-to-operate analysis on US7326708B2 to assess your product’s exposure
Run FTO in Eureka →Similar Hatch-Waxman cases involving DPP-4 inhibitor and metformin formulation patents
Explore related patent infringement actions in Delaware and other districts involving sitagliptin, metformin ER, and DPP-4 inhibitor combination formulation patents.
What this case signals for the branded pharmaceutical IP landscape
Merck’s 81-day consent judgment sets a clear marker on JANUMET XR® defence strategy and Hatch-Waxman settlement dynamics.
Consent injunctions raise the bar for generic challengers in Hatch-Waxman suits
When a brand secures a court-entered injunction — not just a dismissal — it creates a precedent that subsequent ANDA filers must acknowledge. Other manufacturers eyeing sitagliptin/metformin ER should conduct a thorough FTO analysis against US7326708B2 before advancing ANDA filings, as Merck has demonstrated both the willingness and speed to obtain enforceable relief.
Swift settlement preserves patent strength across the entire ANDA landscape
A settlement without merits adjudication leaves US7326708B2 unchallenged. For in-house IP teams at generic manufacturers, this means the patent clock has not been reset or shortened by an invalidity ruling. Any 30-month stay triggered by future ANDA filers will run against a patent that has never been found invalid or not infringed — a meaningful enforcement advantage for Merck.
Merck v Aurobindo — key questions answered
The case settled via consent judgment entered on 1 July 2025, 81 days after filing. Both parties stipulated to judgment and an injunction based on two negotiated Settlement Agreements. No merits ruling on patent validity or infringement was issued. US7326708B2 remains in force.
Merck asserted US7326708B2, a patent covering the sitagliptin/metformin hydrochloride extended release combination tablet formulation commercialised as JANUMET XR®. Aurobindo’s ANDA targeted 100 mg/1000 mg and 50 mg/1000 mg strengths.
The consent injunction is a court-entered order — agreed to by Aurobindo — that restrains its ability to launch the generic product on terms outside the Settlement Agreements. Specific launch date, royalty, or authorised generic provisions remain confidential. Aurobindo avoided a potentially harsher permanent injunction after trial.
No. Because the case settled without any merits adjudication, the patent’s presumption of validity is entirely intact. Other ANDA filers targeting sitagliptin/metformin ER tablets face the same unadjudicated patent barrier and must independently address US7326708B2 in their own Paragraph IV certifications.
Eighty-one days is significantly faster than average Hatch-Waxman litigation, which routinely proceeds to trial over two to three years. The speed likely reflects early commercial negotiations, possibly facilitated by Judge Connolly’s active case management style in Delaware. The dual Settlement Agreements suggest complex licensing terms were agreed in parallel with the litigation.
PatSnap Eureka searches patents and litigation data to answer instantly.