BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | N022410 | INDIVIOR INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2016-01113 | 8475832 | IPR | Dr. Reddy’s Laboratories, Inc. et al. | Institution Denied | 2016-05-31 | — |
| IPR2016-00280 | 8475832 | IPR | Teva Pharmaceuticals USA, Inc. | Institution Denied | 2015-12-03 | — |
| IPR2014-00998 | 8475832 | IPR | BioDelivery Sciences International, Inc. | Institution Denied | 2014-06-20 | — |
| IPR2014-00325 | 8475832 | IPR | BioDelivery Sciences International, Inc. | Final Written Decision | 2014-01-15 | — |
| IPR2019-00328 | 9687454 | IPR | Dr. Reddy's Laboratories S.A. et al. | Institution Denied | 2018-11-13 | — |
| IPR2019-00329 | 9687454 | IPR | Dr. Reddy’s Laboratories S.A. et al. | Final Written Decision | 2018-11-13 | 2022-09-23 |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Indivior Inc. et al v. Actavis Laboratories UT, Inc. 1 patentANDA 204383, 207087buprenorphine hydrochloride and naloxone hydrochloride | D. Del. | 2018-04-03 | Terminated 2019-09-16 | — |
Indivior et al v. Actavis Laboratories UT 2 patentsANDA 204383, 207087buprenorphine hydrochloride and naloxone hydrochloride | D. Utah | 2018-02-07 | Terminated 2018-05-03 | — |
Par Pharmaceutical, Inc. v. Indivior Inc. et al 2 patentsANDA 205854buprenorphine and naloxone | E.D. Va. | 2017-11-13 | Terminated 2018-05-21 | — |
INDIVIOR INC. et al v. PAR PHARMACEUTICAL INC et al 1 patentANDA 205854buprenorphine hydrochloride and naloxone hydrochloride | D.N.J. | 2017-10-06 | Terminated 2018-05-21 | — |
INDIVIOR INC. et al v. ALVOGEN PINE BROOK, INC. 1 patentANDA 205954buprenorphine hydrochloride and naloxone hydrochloride | D.N.J. | 2017-09-14 | Terminated 2023-11-09 | — |
INDIVIOR INC. et al v. TEVA PHARMACEUTICALS USA, INC. 1 patentbuprenorphine hydrochloride and naloxone hydrochloride | D.N.J. | 2017-09-14 | Terminated 2024-01-31 | — |
Indivior Inc. et al v. Teva Pharmaceuticals USA, Inc. 5 patentsANDA 205299, 205806buprenorphine hydrochloride and naloxone hydrochloride | D. Del. | 2016-03-21 | Terminated 2019-09-05 | — |
Reckitt Benckiser Pharmaceuticals Inc. et al v. Par Pharmaceutical Inc. et al 5 patentsANDA 205854buprenorphine hydrochloride and naloxone hydrochloride | D. Del. | 2014-12-31 | Terminated 2017-09-20 | — |
Reckitt Benckiser Pharmaceuticals Inc. et al v. Watson Laboratories Inc. et al. 2 patentsANDA 204383buprenorphine hydrochloride and naloxone hydrochloride | D. Del. | 2014-12-31 | Terminated 2019-10-01 | — |
Indivior, Inc. et al v. Dr. Reddy's Laboratories S.A., et al. 3 patentsANDA 205806buprenorphine hydrochloride and naloxone hydrochloride | D. Del. | 2014-12-02 | Terminated 2019-09-05 | — |
Reckitt Benckiser Pharmaceuticals Inc. et al v. Par Pharmaceutical Inc. et al 3 patentsANDA 020-5854buprenorphine hydrochloride and naloxone hydrochloride | D. Del. | 2014-04-04 | Terminated 2019-09-05 | — |
Reckitt Benckiser Pharmaceuticals Inc. et al v. Par Pharmaceutical Inc. et al 2 patentsANDA 205854buprenorphine hydrochloride and naloxone hydrochloride | D. Del. | 2013-08-20 | Terminated 2014-05-27 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From Lachman Consultant Services, Inc. FDA-2014-P-2058 · 6 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Film in a strength of 16 mg/4 mg is suitable for | Other | 2014-12-02 | Withdrawn | Lachman Consultant Services, Inc. |
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.
Highest NADAC/Unit
$17.17
per ea
Lowest NADAC/Unit
$4.79
per ea
Brand NDCs
4
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 12496121203SUBOXONE 12 MG-3 MG SL FILM | $17.17 | EA | Brand | $4.20 | 2026-06-17 |
| 12496120803SUBOXONE 8 MG-2 MG SL FILM | $8.60 | EA | Brand | $2.06 | 2026-06-17 |
| 12496120403SUBOXONE 4 MG-1 MG SL FILM | $8.59 | EA | Brand | $2.27 | 2026-06-17 |
| 12496120203SUBOXONE 2 MG-0.5 MG SL FILM | $4.79 | EA | Brand | $1.28 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.