BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | N020733 | INDIVIOR INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2016-12-23 | Terminated 2019-05-23 | — | |
Reckitt Benckiser Pharmaceuticals, Inc. et al v. BioDelivery Sciences International, Inc. 4 patentsbuprenorphine hydrochloride and naloxone hydrochloride | E.D.N.C. | 2013-10-29 | Terminated 2014-05-21 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Amendment from Athyna Pharma LLC FDA-2025-P-5272 · 8 docket documents Athyna Pharma LLC submitted an amendment to its October 16, 2025 ANDA suitability petition for Buprenorphine Hydrochloride and Naloxone Hydrochloride sublingual tablets in new strengths of 16/4 mg, 12/3 mg, and 4/1 mg base, correcting the reference listed drug to NDA 020733 (Suboxone) and the refere | Suitability | 2025-11-07 | Granted | — |
Hyman, Phelps & McNamara, P.C. - Citizen Petition FDA-2013-P-0995 · 3 docket documents Hyman, Phelps & McNamara, P.C. filed this Section 505(q) citizen petition requesting that FDA refuse to file any 505(b)(2) NDA for a buprenorphine/naloxone buccal polymer film product unless it references NDA No. 22-410 for SUBOXONE sublingual film as the listed drug and makes appropriate patent cer | 505(q) | 2013-09-05 | Partially Denied | — |
Lachman Consultant Sevices, Inc.- Citizen Petition FDA-2012-P-1034 · 5 docket documents Lachman Consultant Services, Inc., on behalf of a client, filed this citizen petition requesting that the FDA determine whether SUBOXONE Sublingual Tablets (buprenorphine hydrochloride and naloxone hydrochloride) 2 mg/0.5 mg and 8 mg/2 mg, approved under NDA 20-733, were voluntarily withdrawn from s | 505(q) | 2012-10-01 | Denied | — |
Hyman, Phelps & McNamara, P.C. - Citizen Petition FDA-2011-P-0869 · 5 docket documents Hyman, Phelps & McNamara, P.C., on behalf of the holder of NDA #22-410 for SUBOXONE sublingual film, petitioned the FDA to refuse to file any 505(b)(2) NDA for a buprenorphine/naloxone polymer film product for oral mucosal application unless the applicant references NDA #22-410 rather than the table | 505(q) | 2011-12-20 | Partially Denied | — |
Reckitt Benckiser Pharmaceuticals Inc. - Citizen Petition FDA-2009-P-0325 · 6 docket documents Reckitt Benckiser Pharmaceuticals Inc. filed this citizen petition pursuant to Sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA require generic applicants submitting ANDAs and 505(b)(2) NDAs for Subutex (buprenorphine) and Suboxone (buprenorphine/naloxone) s | 505(q) | 2009-08-04 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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