Supernus v. Ajanta Pharma: Plaintiff Wins on 10 Trokendi XR® Patents
Supernus Pharmaceuticals secured a merits judgment against Ajanta Pharma and Ajanta Pharma USA in the District of New Jersey, protecting its Trokendi XR® topiramate extended-release franchise across 10 asserted patents. The court found the key patents not invalid and infringed, requiring Ajanta to notify the FDA of the outcome.
Case duration: filed March 2021, closed February 2024
Patents asserted
10
US8992989B2, US9549940B2, US9622983B2 and 7 further patents asserted
Outcome
Judgment on the merits for Plaintiff
Judgment on the merits — Ajanta’s ANDA blocked; FDA must be notified of infringement
Cost ruling
N/A
No public cost award recorded in the case data
Published byPatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview
Supernus defends Trokendi XR® franchise with 10-patent win in New Jersey
Supernus Pharmaceuticals, Inc. filed suit on March 26, 2021 in the U.S. District Court for the District of New Jersey against Ajanta Pharm Limited and its U.S. affiliate Ajanta Pharma USA Inc. The dispute arose from Ajanta’s ANDA seeking FDA approval to market generic versions of Trokendi XR® — topiramate extended-release capsules in 25 mg, 50 mg, 100 mg, and 200 mg strengths. Supernus asserted ten U.S. patents covering the formulation, spanning application filings from 2007 through 2016.
The court entered judgment in favor of Supernus on the merits, closing the case on February 22, 2024. The verdict explicitly found that the ‘989 and ‘983 patents are not invalid, and ordered Ajanta to inform the U.S. FDA that the ‘989, ‘940, and ‘983 patents are infringed by Ajanta’s proposed generic product. This FDA notification requirement is a standard but consequential ANDA litigation outcome: it triggers the statutory exclusion period and prevents final FDA approval of Ajanta’s ANDA while any appeal period runs.
The case ran approximately 35 months from filing to judgment, consistent with contested Hatch-Waxman ANDA litigation in New Jersey. The breadth of the patent portfolio — ten patents covering multiple formulation and dosing aspects — suggests Supernus pursued a layered enforcement strategy designed to make any design-around difficult. What remains unknown from the public record is whether Ajanta has appealed, and whether any patents beyond the ‘989, ‘940, and ‘983 were adjudicated or narrowed during the proceeding.
Case data sourced from PACER / New Jersey District Court via PatSnap Eureka Litigation IntelligenceExplore similar cases ↗
Case timeline
Filing to filing in 1063 days
Case duration: filed March 2021, closed February 2024
Court ruling
Judgment on the merits: Supernus prevails on validity and infringement
Legal mechanism
Hatch-Waxman ANDA litigation: how this judgment works
Under the Hatch-Waxman Act, an ANDA filer’s Paragraph IV certification triggers a 30-month stay on FDA approval. A merits judgment of infringement and validity extends that block beyond the stay period. Ajanta must now notify the FDA of this outcome, preventing final approval of its generic topiramate ER product unless and until any appeal succeeds or a settlement is reached.
The verdict language — ‘not invalid’ rather than ‘valid’ — reflects the presumption of validity standard in U.S. patent law: defendants must prove invalidity by clear and convincing evidence. The court’s finding that Ajanta failed to meet that burden on the ‘989 and ‘983 patents strengthens Supernus’s enforcement position for the remainder of those patents’ terms, and signals the difficulty of mounting an invalidity challenge against this portfolio.
Three patents explicitly found infringed: ‘989, ‘940, and ‘983
The verdict identifies three patents — US8992989B2, US9549940B2, and US9622983B2 — as infringed by Ajanta’s proposed ANDA product. The remaining seven asserted patents are not explicitly named in the verdict summary, which may reflect claim narrowing, stipulations, or procedural resolution during the litigation. The three named patents collectively cover formulation and extended-release delivery aspects of topiramate capsules.
Court-ordered FDA notice locks out Ajanta’s approval pathway
The judgment explicitly orders Ajanta to inform the U.S. FDA of the infringement finding. This is a standard Hatch-Waxman remedy that closes the regulatory approval pathway for Ajanta’s generic topiramate ER product. It preserves Supernus’s market exclusivity for Trokendi XR® and signals to other potential ANDA filers that the core patents in this portfolio have survived litigation scrutiny.
“Thejudgmententered in Favor ofSupernus regarding the 989 patent is not invalid; The judgmententered in Favor ofSupernus regarding the 983 patent is not invalid; Torrent shall inform the U.S. FDA of this final judgment and that the 989, 940,and 983 patent are infringed”
Source: PACER Docket, Case 3:21-cv-06964, New Jersey District Court · Filed February 22, 2024
The verdict language is precise and consequential. The ‘not invalid’ finding on the ‘989 and ‘983 patents confirms that Ajanta failed to meet the clear-and-convincing evidence burden required to overcome U.S. patent validity presumptions. The explicit FDA notification order on three patents — ‘989, ‘940, and ‘983 — operationalises the infringement finding by closing Ajanta’s regulatory approval pathway. For Supernus, this is a durable outcome: the core patents have now survived adversarial validity scrutiny, strengthening their deterrence value against future ANDA filers.
The ten asserted patents protect Supernus’s Trokendi XR® product — topiramate extended-release capsules indicated for epilepsy and migraine prevention. Application dates span from 2007 (US11/941475, issuing as US8298576B2) through 2016 (US15/259856, issuing as US9622983B2), reflecting a sustained prosecution strategy. The portfolio covers multiple dimensions of the extended-release formulation, including composition, dosing regimens, and drug-release profiles, making it structurally difficult for a generic challenger to design around any single patent while remaining bioequivalent.
Topiramate is a well-established antiepileptic agent; the commercial value of the extended-release franchise lies in the formulation IP rather than the molecule itself. Supernus’s multi-layer patent estate — now validated through contested ANDA litigation — creates a meaningful barrier to generic entry until the later-expiring patents in the portfolio expire. For competitors in the CNS extended-release space, this case signals that formulation-layered portfolios will be defended aggressively and are capable of withstanding validity challenges in federal court.
Should your ANDA or ER formulation product be cleared against this portfolio?
Any company developing a generic or branded extended-release topiramate product — or an ER capsule formulation in an adjacent CNS indication — should conduct a rigorous freedom-to-operate analysis against all ten patents in the Supernus Trokendi XR® estate. Three patents have now survived adversarial validity scrutiny in federal litigation, raising the evidentiary bar for any invalidity argument. R&D teams designing ER capsule formulations should map their proposed product against each asserted claim before committing to an ANDA filing strategy.
PatSnap Eureka’s FTO Search Agent can map your product’s formulation parameters against the claim language of each of the ten asserted patents, flag prosecution history estoppel risks, and identify prior art that was not raised in the Ajanta litigation. Ongoing claim monitoring across the Supernus portfolio will alert your team to any continuation filings or reissue activity that could extend the effective protection window beyond currently visible expiry dates.
PatSnap Eureka FTO Search
Run a freedom-to-operate analysis on US8298576B2 to assess your product’s exposure
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Portfolio view
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What this case signals for the topiramate ER and CNS generics IP landscape
A 10-patent merits win in New Jersey sends a clear signal to generic CNS manufacturers eyeing Trokendi XR® equivalents.
Layered patent portfolios make ANDA challenges structurally harder
Supernus’s assertion of ten patents across multiple formulation and dosing dimensions — spanning nearly a decade of filings — illustrates how originator pharma companies construct portfolios designed to survive partial invalidity findings. Even if some patents fall, others remain to block approval. Generic challengers should model full portfolio clearance, not just lead-compound analysis, before filing an ANDA.
New Jersey remains a plaintiff-favorable forum for Hatch-Waxman disputes
The District of New Jersey is one of the most active venues for ANDA litigation in the U.S. This outcome is consistent with the district’s pattern of fully adjudicating contested pharmaceutical patent cases through trial. Companies evaluating ANDA filing strategy should factor New Jersey’s docket history and judicial familiarity with Hatch-Waxman mechanics into forum risk assessments.
Topiramate ER patent expiry windows: when the market opens
The ten asserted patents span application dates from 2007 to 2016, suggesting expiry dates ranging from the mid-2020s to mid-2030s. Generic entrants should map each patent’s adjusted expiry against any pediatric exclusivity or patent term extension to identify the earliest defensible market entry window. PatSnap Eureka can model this timeline patent by patent.
Ajanta appeal probability and competitive entry signal
A merits loss on infringement and validity across the lead patents typically precedes either an appeal to the Federal Circuit or a licensing negotiation. Monitoring Ajanta’s appeal filing — and any subsequent Federal Circuit briefing schedule — is a leading indicator of when competitive generic entry may realistically occur in the topiramate ER segment.
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Frequently asked questions
Supernus v Ajanta — key questions answered
Supernus Pharmaceuticals won a judgment on the merits. The court found the ‘989 and ‘983 patents not invalid and ordered Ajanta to notify the FDA that the ‘989, ‘940, and ‘983 patents are infringed by its proposed generic topiramate extended-release product, blocking ANDA approval.
Supernus asserted ten U.S. patents: US8298576B2, US9622983B2, US8663683B2, US8877248B1, US8889191B2, US10314790B2, US8298580B2, US8992989B2, US9555004B2, and US9549940B2, all covering aspects of the Trokendi XR® topiramate extended-release capsule formulation.
The court order requiring Ajanta to notify the FDA of the infringement finding effectively blocks final approval of Ajanta’s ANDA for generic topiramate extended-release capsules. FDA cannot grant final approval while the infringement finding stands, unless Ajanta successfully appeals or reaches a settlement with Supernus.
Under U.S. patent law, issued patents carry a presumption of validity that challengers must overcome by clear and convincing evidence. A ‘not invalid’ finding means Ajanta failed to meet that burden. This strengthens the enforceability of the ‘989 and ‘983 patents against future ANDA filers and raises the bar for any subsequent invalidity challenge.
Supernus was represented by Saul Ewing Arnstein & Lehr LLP, with William C. Baton as lead counsel. Ajanta was represented by Hill Wallack LLP and Sterne Kessler Goldstein & Fox, with attorneys Dennies Varughese, Eric I. Abraham, Nakul Y. Shah, and William Murtha.
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PatSnap Eureka maps your formulation against all ten asserted patents and monitors for continuation filings. Identify your earliest defensible market entry window before committing to an ANDA strategy.
