Indivior v. Teva Pharmaceutical: Suboxone Film Patent Dismissed With Prejudice After 6+ Years
Indivior Inc. and Indivior UK Limited filed an infringement action against Teva Pharmaceutical Industries over US9687454B2, a patent covering the Suboxone® sublingual film formulation. Filed in New Jersey District Court in September 2017, the case ran 2,330 days — over six years — before closing on a stipulated dismissal with prejudice in January 2024.
Six-year Suboxone film patent battle ends by stipulation in New Jersey
Indivior Inc. and its UK affiliate Indivior UK Limited initiated this infringement action on 14 September 2017 in the District of New Jersey, asserting US9687454B2 against Teva Pharmaceutical Industries, Ltd. The patent-in-suit relates to the Suboxone® sublingual film, a buprenorphine/naloxone combination product used in opioid use disorder treatment and one of the most commercially contested formulations in the pharmaceutical generics landscape. New Jersey — home to many major pharmaceutical defendants — was the chosen venue, consistent with Hatch-Waxman ANDA litigation patterns in this district.
The case closed on 31 January 2024 via a Stipulation and Order of Voluntary Dismissal with prejudice, signed by both parties and entered by the court. Dismissal with prejudice is a final adjudication on the merits for res judicata purposes: Indivior is permanently barred from reasserting the same claims under US9687454B2 against Teva in any subsequent proceeding. The stipulated nature of the order indicates that both parties agreed to the resolution, which is consistent with a confidential settlement — though no settlement terms have been made public.
At 2,330 days, the case duration is notably long even by Hatch-Waxman standards, suggesting contested claim construction, possible IPR or inter partes proceedings running in parallel, or protracted commercial negotiations. The public record does not disclose whether a licensing arrangement, market-entry agreement, or other commercial term drove the parties to stipulate dismissal. What is clear is that Indivior’s infringement claims under this specific patent will not proceed further against Teva.
Filing to dismissal in 2330 days
2,330 days — well above the median for ANDA-linked pharmaceutical patent cases in federal district court
Voluntary dismissal with prejudice: what the stipulated order means for both parties
Stipulated dismissal with prejudice explained
A stipulated dismissal with prejudice means both parties jointly asked the court to close the case on terms that permanently extinguish Indivior’s claims under US9687454B2 against Teva. Unlike a court-ordered dismissal, a stipulation reflects mutual consent. Under FRCP Rule 41(a)(1)(A)(ii), once both parties sign and the court enters the order, the dismissal is with prejudice by its own terms — no further action is needed from the judge to make it final.
FRCP Rule 41 — consensual closureIndivior is barred from refiling these claims against Teva
With prejudice means the dismissal operates as a final judgment on the merits for res judicata purposes. Indivior cannot refile the infringement claims asserted in this action against Teva under US9687454B2 in any future proceeding. This is categorically different from a dismissal without prejudice, where the plaintiff retains the right to refile. The with-prejudice designation is significant protection for Teva — it forecloses renewed litigation on these specific claims.
Permanent bar — cannot refileConfidential terms likely underlie the stipulation
Stipulated dismissals with prejudice in pharmaceutical patent cases — particularly Hatch-Waxman matters — frequently reflect a confidential commercial agreement reached between the parties, such as a licensing deal, authorised generic arrangement, or agreed market-entry date. The public record contains no disclosed terms. The six-year duration and the consent of both sophisticated parties suggests negotiation rather than unilateral concession, but the specific commercial arrangement, if any, remains unknown.
Terms undisclosedUS9687454B2 may still be enforceable against other defendants
The dismissal with prejudice binds only the parties to this action — Indivior and Teva. US9687454B2 remains a granted US patent and Indivior retains the right to assert it against other generic manufacturers who have filed ANDAs or otherwise seek to market competing sublingual film products. Companies monitoring the Suboxone generics landscape should track the patent’s remaining term and any pending or parallel ANDA litigation by Indivior against other filers.
Enforceable vs. third partiesFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Indivior, Inc. | Company | Pharmaceutical company focused on addiction treatment — holder of US9687454B2Search in Eureka ↗ |
| Defendant | Teva Pharmaceutical Industries, Ltd. | Company | Teva Pharmaceutical Industries, Ltd. — global generic and specialty drug manufacturerSearch in Eureka ↗ |
| Plaintiff counsel | Amanda Lyn Genovese | Attorney | Counsel for Indivior, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Charles Michael Lizza | Attorney | Counsel for Indivior, Inc.Search in Eureka ↗ |
| Plaintiff counsel | David Leigh Moses | Attorney | Counsel for Indivior, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Katherine Harihar | Attorney | Counsel for Indivior, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Philip Scott May | Attorney | Counsel for Indivior, Inc.Search in Eureka ↗ |
| Plaintiff counsel | William C. Baton | Attorney | Counsel for Indivior, Inc.Search in Eureka ↗ |
| Defendant counsel | Christine Intromasso Gannon | Attorney | Counsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Defendant counsel | Gerhard William Buehning | Attorney | Counsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Defendant counsel | Liza M. Walsh | Attorney | Counsel for Teva Pharmaceutical Industries, Ltd.Search in Eureka ↗ |
| Presiding judge | Judge / | Chief Judge | New Jersey District Court — Chief JudgeSearch in Eureka ↗ |
Stipulation of dismissal — official text
The Stipulation and Order of Voluntary Dismissal with prejudice was entered jointly by both parties, indicating mutual consent to end the litigation permanently. The with-prejudice designation means the order functions as a final merits adjudication for claim-preclusion purposes — Indivior’s infringement claims under US9687454B2 against Teva are extinguished. The stipulated form, rather than a unilateral plaintiff filing, suggests both parties negotiated the closure terms, though no commercial terms are publicly disclosed. This order does not reflect any court finding on infringement or validity.
US9687454B2 — Suboxone® sublingual film drug delivery formulation
US9687454B2 (application number US14/989669) covers aspects of the Suboxone® sublingual film — a buprenorphine and naloxone combination product administered under the tongue for the treatment of opioid use disorder. Sublingual film delivery of opioid agonist/antagonist combinations involves precise formulation science: film-forming polymers, drug loading, dissolution profiles, and mucosal permeability must be engineered together. Patents in this space typically claim the specific composition, manufacturing process, or pharmacokinetic profile that distinguishes the branded product from a straightforward generic equivalent.
Suboxone® sublingual film is a high-value commercial product in the opioid use disorder market, and US9687454B2 represents part of Indivior’s defensive IP estate around it. For generic manufacturers, the patent creates a significant clearance requirement before an ANDA can proceed to approval without triggering Paragraph IV certification litigation. Given Indivior’s demonstrated willingness to assert this patent in multi-year litigation against major generic players like Teva, the strategic weight of US9687454B2 in the sublingual buprenorphine space should not be underestimated by any company developing competing formulations.
Should your team run an FTO against US9687454B2?
Any pharmaceutical company developing, filing an ANDA for, or commercialising a buprenorphine/naloxone sublingual film product in the US market should conduct a formal freedom-to-operate analysis against US9687454B2. This is not a speculative risk — Indivior has actively litigated this patent for over six years against Teva, one of the world’s largest generic manufacturers. The dismissal with prejudice binds only Teva; all other market entrants remain exposed. FTO review should also assess related family members and continuation applications.
PatSnap Eureka’s FTO Search Agent can map the full claim scope of US9687454B2, identify related patent family members and continuation filings, and flag product features that intersect with granted claims. Eureka’s claim monitoring tools can also alert your team if Indivior files new continuations or divisionals in the sublingual film space — critical intelligence for any company tracking the Suboxone generics market. Run your FTO analysis before ANDA filing, not after a complaint lands.
Run a freedom-to-operate analysis on US9687454B2 to assess your product’s exposure
Run FTO in Eureka →Similar Hatch-Waxman sublingual film and opioid treatment patent cases
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What this case signals for the opioid treatment drug IP landscape
A six-year Suboxone film patent dispute ending by stipulation carries real signals for generic entrants, brand defenders, and IP teams tracking addiction-treatment formulations.
Long pharmaceutical patent cases often settle quietly — watch the stipulation date
This case ran more than six years before closing without a public merits ruling. In Hatch-Waxman litigation, a late stipulated dismissal with prejudice typically suggests the parties reached a commercial resolution — possibly an authorised generic arrangement or a defined market-entry date. IP teams should not assume silence means the patent is weak; it may mean the economics favoured a deal over continued litigation.
US9687454B2 remains live against other Suboxone film generic filers
The with-prejudice dismissal only bars Teva from being re-sued on these claims. Any other ANDA filer for a buprenorphine/naloxone sublingual film remains fully exposed to Indivior asserting US9687454B2. Companies in late-stage development or ANDA preparation for competing sublingual opioid treatment films should treat this patent as an active enforcement risk and conduct formal FTO analysis before filing.
Indivior v Teva — key questions answered
The case was dismissed with prejudice on 31 January 2024 via a Stipulation and Order of Voluntary Dismissal signed by both parties. This permanently bars Indivior from refiling the same infringement claims under US9687454B2 against Teva. No merits ruling on infringement or validity was issued by the court.
Indivior asserted US9687454B2 (application number US14/989669), a patent covering the Suboxone® sublingual film — a buprenorphine and naloxone combination product used to treat opioid use disorder. The case was a Hatch-Waxman infringement action filed in the District of New Jersey on 14 September 2017.
No. The dismissal with prejudice binds only the named parties — Indivior and Teva. US9687454B2 remains a granted patent, and Indivior retains full rights to assert it against any other ANDA filer or generic manufacturer seeking to market a competing buprenorphine/naloxone sublingual film product in the United States.
The public record does not disclose the specific reasons for the case’s 2,330-day duration. Lengthy ANDA patent cases often involve contested claim construction proceedings, parallel USPTO validity challenges, or extended commercial negotiations. The eventual stipulated dismissal with prejudice is consistent with a private commercial resolution, though no terms have been publicly disclosed.
A stipulated dismissal with prejudice means both parties jointly agreed to end the litigation permanently. Under FRCP Rule 41, it operates as a final judgment on the merits for res judicata purposes, preventing the plaintiff from refiling the same claims. In Hatch-Waxman cases, such stipulations frequently reflect an underlying commercial agreement — such as a licensing deal or authorised generic arrangement — though terms are typically not disclosed publicly.
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