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SUBOXONE

NDA

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | N020733 | INDIVIOR INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Rhodes Pharmaceuticals L.P. v. Indivior Inc. 1:2016cv01308 1 patentbuprenorphine and naloxone	D. Del.	2016-12-23	Terminated 2019-05-23	—
Reckitt Benckiser Pharmaceuticals, Inc. et al v. BioDelivery Sciences International, Inc. 5:2013cv00760 4 patentsbuprenorphine hydrochloride and naloxone hydrochloride	NCED	2013-10-29	Terminated 2014-05-21	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition Amendment from Athyna Pharma LLC FDA-2025-P-5272 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	Open	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Suboxone (2023)

Total Spending

$95.3M

Total Claims

199,315

Beneficiaries

22,745

Avg Cost/Unit

$9.96

Spending Trend

$188.4M(2019)→$139.9M(2020)→$119.6M(2021)→$105.3M(2022)→$95.3M(2023)

YoY Change:+1.8%

5yr CAGR:+2.8%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

22 letters from Drugs@FDA

Date	Submission	Document
Jun 21, 2022	SUPPL -32	View Letter (PDF)
Jun 21, 2022	SUPPL -31	View Letter (PDF)
May 4, 2022	SUPPL -30	View Letter (PDF)
Nov 23, 2021	SUPPL -29	View Letter (PDF)
Mar 5, 2021	SUPPL -28	View Letter (PDF)
Mar 4, 2020	SUPPL -27	View Letter (PDF)
Nov 1, 2019	SUPPL -24	View Letter (PDF)
Oct 9, 2019	SUPPL -26	View Letter (PDF)
Oct 29, 2018	SUPPL -25	View Letter (PDF)
Jun 14, 2018	SUPPL -23	View Letter (PDF)
Feb 2, 2018	SUPPL -22	View Letter (PDF)
Sep 22, 2017	SUPPL -21	View Letter (PDF)
Sep 20, 2017	SUPPL -20	View Letter (PDF)
Dec 20, 2016	SUPPL -19	View Letter (PDF)
Dec 20, 2016	SUPPL -18	View Letter (PDF)
Jul 12, 2016	SUPPL -17	View Letter (PDF)
Sep 24, 2015	SUPPL -16	View Letter (PDF)
Dec 12, 2014	SUPPL -14	View Letter (PDF)
Jan 3, 2012	SUPPL -8	View Letter (PDF)
Jan 3, 2012	SUPPL -7	View Letter (PDF)
Oct 13, 2006	SUPPL -3	View Letter (PDF)
Oct 8, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;SUBLINGUAL | Approved: Oct 8, 2002

No patent or exclusivity listings for this strength.

#002 — EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;SUBLINGUAL | Approved: Oct 8, 2002