Adverio Pharma & Bayer v. Alembic: ADEMPAS® Patent Case Terminated After Reported Settlement
Adverio Pharma GmbH and Bayer entities filed a patent infringement action against Alembic in the District of New Jersey, asserting two patents covering ADEMPAS® riociguat tablets across five dosage strengths. The case was administratively terminated after 395 days following a reported settlement, with the court ordering dismissal papers to be filed within 60 days.
Bayer and Adverio's ADEMPAS® patents tested against Alembic's generic entry
On October 17, 2022, Adverio Pharma GmbH, Bayer Healthcare Pharmaceuticals, Inc., and Bayer AG filed a patent infringement action against Alembic, Alembic Global Holding SA, and Alembic Pharmaceuticals, Inc. in the United States District Court for the District of New Jersey. The suit asserted US10662188B2 and US11203593B2, covering ADEMPAS® (riociguat) tablets at dosage strengths of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, and 2.5 mg — a product used in the treatment of pulmonary hypertension.
On November 16, 2023, the court entered an administrative termination order after the parties reported a settlement. The recorded basis of termination is 'Case Terminated.' The docket order expressly states this termination does not constitute a dismissal under the Federal Rules of Civil Procedure, and directed the parties to file dismissal papers under Rule 41 within 60 days, failing which the court indicated it would dismiss the action with prejudice and without costs absent further instruction.
The case resolved in approximately 395 days without proceeding to trial — consistent with the pace seen in many Hatch-Waxman pharmaceutical patent disputes that settle before a scheduled trial date. The specific terms of any agreement between the parties are not disclosed in the available public record.
See Complete Case & Patent Analysis →Filing to Case Terminated in 395 days
395 days from filing to administrative termination — typical for ANDA/pharma patent disputes resolved before trial
US10662188B2 & US11203593B2 — Riociguat tablet formulations for ADEMPAS®
Any pharmaceutical company developing or seeking to launch a generic or biosimilar riociguat product — or any sGC stimulator tablet in the ADEMPAS® dosage range — should treat US10662188B2 and US11203593B2 as live enforcement risks. Both patents emerged from this litigation without judicial narrowing of their claims. R&D and regulatory teams preparing ANDA filings for riociguat should conduct a thorough FTO review before committing to a Paragraph IV certification strategy.
Official order — verbatim text
The November 16, 2023 order administratively terminates the case on the basis of a reported settlement, while explicitly stating it does not constitute a Rule 41 dismissal. The order retains a 60-day mechanism requiring formal dismissal papers or a request to reopen — reflecting standard New Jersey District Court practice. No merits determination was reached on infringement or validity of US10662188B2 or US11203593B2.
Case terminated: what the administrative order means for both parties
Administrative termination — not a Rule 41 dismissal order
The court's November 2023 order expressly states it does not constitute a dismissal under the Federal Rules of Civil Procedure. Instead, it administratively terminates the case following a reported settlement and requires the parties to file formal Rule 41 dismissal papers within 60 days. This is a standard docket-management device used by New Jersey federal courts to close active cases pending completion of settlement formalities.
Administrative terminationPlaintiffs secure a reported resolution before trial
Adverio Pharma and Bayer avoided trial and the uncertainty of a full infringement and validity determination. A reported settlement at this stage typically signals that some accommodation was reached regarding the asserted ADEMPAS® patents. The specific terms — including any licensing, market entry date, or other conditions — are not disclosed in the available public record.
Reported settlementAlembic avoids adverse judgment but terms are undisclosed
Alembic and its affiliates avoided a court ruling on infringement or validity of the two asserted patents covering ADEMPAS® riociguat tablets. Whether the reported settlement imposes conditions on Alembic's ability to market a generic version of ADEMPAS® — including any agreed launch date — is not disclosed in the available public record.
No merits rulingADEMPAS® generic entry timeline remains opaque to third parties
Because the settlement terms are not public, competing generic manufacturers and market participants cannot determine what market-access conditions, if any, were agreed between the parties. The two asserted patents — US10662188B2 and US11203593B2 — remain issued and enforceable. Any third party seeking to launch a competing riociguat product should treat these patents as active enforcement assets until expiry or successful challenge.
IP enforcement risk remainsFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Adverio Pharma GmbH | Company | /Search in Eureka ↗ |
| Co-Plaintiff | Bayer Healthcare Pharmaceuticals, Inc. | Company | Search in Eureka ↗ |
| Co-Plaintiff | Bayer AG | Company | Search in Eureka ↗ |
| Defendant | Alembic | Individual | /Search in Eureka ↗ |
| Co-Defendant | Alembic Global Holding SA | Company | Search in Eureka ↗ |
| Co-Defendant | Alembic Pharmaceuticals, Inc. | Company | Search in Eureka ↗ |
| Plaintiff counsel | Charles H. Chevalier | Attorney | Counsel for Adverio Pharma GmbHSearch in Eureka ↗ |
| Plaintiff counsel | Christine A. Gaddis | Attorney | Counsel for Adverio Pharma GmbHSearch in Eureka ↗ |
| Plaintiff counsel | David E. Delorenzi | Attorney | Counsel for Adverio Pharma GmbHSearch in Eureka ↗ |
| Plaintiff law firm | Gibbons, PC | Law Firm | Representing Adverio Pharma GmbHSearch in Eureka ↗ |
| Plaintiff law firm | Gibbons PC | Law Firm | Representing Adverio Pharma GmbHSearch in Eureka ↗ |
| Defendant counsel | Kaan Ekiner | Attorney | Counsel for AlembicSearch in Eureka ↗ |
| Defendant law firm | Cozen O'connor PC | Law Firm | Representing AlembicSearch in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | New Jersey District CourtSearch in Eureka ↗ |
R&D signals in the riociguat and sGC stimulator patent space
Forward-looking patent and innovation intelligence for the riociguat franchise, Bayer's sGC stimulator portfolio, and generic competitive positioning by Alembic in pulmonary hypertension.
Bayer and Adverio's riociguat patent family depth
Beyond US10662188B2 and US11203593B2, Bayer and Adverio Pharma have filed and prosecuted a broader family of patents covering riociguat formulations, methods of treatment, and dosing regimens. Mapping the full family reveals potential continuation and divisional applications that could extend exclusivity beyond the currently listed Orange Book patents — a critical signal for any generic development roadmap.
Bayer riociguat patent familyFiling trends in sGC stimulator and pulmonary hypertension tablet formulations
Soluble guanylate cyclase stimulators represent an active area of pharmaceutical patent filing activity. Tracking application volumes, assignee diversity, and claim focus in this class can reveal whether competitors are developing next-generation sGC stimulator formulations or dosing innovations that could compete with or design around the ADEMPAS® franchise.
sGC stimulator filing trendsAlembic's US patent challenge and ANDA filing activity
Alembic is an established generic pharmaceutical company with an active US ANDA pipeline. Analysing its US patent litigation history, IPR petition activity, and Orange Book certification patterns can surface which other branded drug patents it is currently challenging — providing early signals of where Alembic's next generic launches may be directed.
Alembic generic pipelineAdjacent R&D opportunities in pulmonary hypertension therapeutics
The riociguat IP thicket around ADEMPAS® dosage formulations may be directing R&D investment toward alternative pulmonary hypertension mechanisms — including phosphodiesterase inhibitors, prostacyclin analogs, and endothelin receptor antagonists. Mapping white space around these adjacencies can identify lower-risk formulation or combination therapy opportunities for pipeline development.
PH therapeutic white spaceSimilar ANDA patent litigation in the pulmonary hypertension space
Explore comparable Hatch-Waxman infringement actions in the New Jersey District Court involving pharmaceutical tablet formulation patents and generic entry challenges.
What this case signals for the pulmonary hypertension IP landscape
Bayer's willingness to enforce two separate riociguat patents against a single generic challenger signals active portfolio management in this therapeutic class.
Two-patent assertion against one generic filer raises the litigation cost calculus
Asserting both US10662188B2 and US11203593B2 simultaneously forces a generic entrant to challenge validity and non-infringement on multiple fronts. For potential ADEMPAS® ANDA filers, this dual-patent strategy significantly increases the cost and risk of a Paragraph IV certification challenge.
Early termination without trial preserves both parties' litigation optionality
A case terminated before claim construction or summary judgment means no adverse claim scope ruling entered against the patent holder. For Bayer and Adverio, the patents emerge from this litigation without any judicial narrowing of their scope — maintaining full enforcement leverage against future generic challengers.
Adverio v Alembic — key questions answered
The plaintiffs asserted two patents: US10662188B2 (application US16/119671) and US11203593B2 (application US16/848249). Both patents relate to ADEMPAS® (riociguat) tablet formulations covering dosage strengths of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, and 2.5 mg.
The recorded basis of termination is 'Case Terminated.' The court entered an administrative termination order on November 16, 2023 after the parties reported a settlement. The order expressly stated it did not constitute a Rule 41 dismissal and required the parties to file formal dismissal papers within 60 days.
The product at issue was ADEMPAS® (riociguat) tablets in five dosage strengths: 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, and 2.5 mg. ADEMPAS® is approved for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.
Both patents remain issued. No court ruling on infringement or validity was entered in this case. The administrative termination following reported settlement means neither patent had its claims judicially narrowed or invalidated. They should be treated as enforceable assets by any party assessing freedom to operate in the riociguat space.
The case lasted 395 days, from filing on October 17, 2022 to administrative termination on November 16, 2023. This duration is consistent with Hatch-Waxman ANDA cases that resolve by reported settlement before reaching claim construction or trial.
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