Buprenorphine/naloxone: trials, targets and approvals

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Comparator or background therapy1 trial
Phase 4	NCT04091009 Comparator	Oct 2019 → Dec 2025	opiate dependence	Massachusetts General Hospital	Withdrawn	No outcome recorded Stop: Business

Date	Issuer	Release
2019-06-18	Indivior Inc.	Indivior \| Indivior Announces Validation of Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for SUBOXONE (buprenorphine and naloxone) Sublingual Film indivior.com ↗
2019-03-29	Orexo AB	District Court of Delaware rules that Actavis does not infringes with their Suboxone® and Subutex® generics orexo.com ↗
2019-02-20	Indivior Inc.	Indivior \| Indivior Announces Launch of SUBOXONE® (buprenorphine and naloxone) Sublingual Film Authorized Generic indivior.com ↗
2019-02-20	Alvogen Korea	Alvogen Launches Generic Equivalent to Suboxone® (buprenorphine/naloxone) Sublingual Film alvogen.com ↗
2019-02-05	XenoPort, Inc.	Aquestive Therapeutics Provides Update Regarding Suboxone® Sublingual Film Litigation aquestive.com ↗
2018-07-17	XenoPort, Inc.	Court Ruling in Favor of Aquestive Therapeutics Enjoining Dr. Reddy's Laboratories from Launching its Generic Suboxone Product aquestive.com ↗
2018-06-15	Indivior Inc.	Indivior \| Indivior Responds to Generic SUBOXONE® Approvals and Dr. Reddy’s Launch “At-Risk” indivior.com ↗
2018-03-23	Lotus Pharmaceutical	Alvogen US and Lotus found not to infringe Suboxone sublingual film patents in the US market lotuspharm.com ↗
2014-06-25	Orexo AB	Top-line data from a Phase 3 clinical trial demonstrates that Zubsolv® is as effective as Suboxone® film in the treatment of opioid dependence orexo.com ↗

Every value below carries the sentence it was read from. 1 source stands behind the page.

Field	Value	Cited text
Known as	Buprenorphine/naloxone	ClinicalTrials.gov intervention name — accepted as the source's own label NCT04091009 ↗
Known as	suboxone	“Buprenorphine (subutex) and buprenorphine/naloxone (suboxone) are effective long-term treatments for substance use disorders.” NCT04091009 ↗