Viewing data from:

BRIXADI

NDA

BUPRENORPHINE | N210136 | BRAEBURN INC

7 strengths8 unique patents1 unique exclusivity

Patent Timeline

8 unique patents, 1 exclusivity by expiration date

Expiring < 1yr (2)Active (6)TodayExclusivity

2027

2028

2029

2030

2031

2032

Today

Jan. 10, 2027

Jul. 31, 2026

Jul. 26, 2032

Jul. 26, 2032

Jul. 26, 2032

Jul. 26, 2032

Jul. 26, 2032

Jul. 26, 2032

May. 23, 2026

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Brixadi (2023)

Total Spending

$363K

Total Claims

269

Beneficiaries

139

Avg Cost/Unit

$4383.89

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

API Supply Chain12 active DMFs3 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

INDIVIOR UK LTDBUPRENORPHINE HCI

DMF 124121997

NORAMCO LLCBUPRENORPHINE BASE (R371605) DRUG SUBSTANCE

DMF 236842010

SPECGX LLCBUPRENORPHINE BASE EP, CODE 3205

DMF 249282012

SIEGFRIED LTDBUPRENORPHINE

DMF 260522012

MACFARLAN SMITH LTD A JOHNSON MATTHEY COBUPRENORPHINE

DMF 264482012

AREVIPHARMA GMBHBUPRENORPHINE

DMF 275472013

TAPI NL BVBUPRENORPHINE

DMF 280752014

SIEGFRIED USA LLCBUPRENORPHINE

DMF 290912015

NORAMCO LLCBUPRENORPHINE HYDROCHLORIDE, USP

DMF 298852016

NORAMCO LLCBUPRENORPHINE

DMF 307622016

SUN PHARMACEUTICAL INDUSTRIES LTDBUPRENORPHINE BASE

DMF 330972019

CHR OLESEN SYNTHESIS ASBUPRENORPHINE HCl USP

DMF 359882021

DIOSYNTH BVInactiveBUPRENORPHINE

DMF 85421990

TASMANIAN ALKALOIDS PTY LTDInactiveBUPRENORPHINE BASE

DMF 118601996

TASMANIAN ALKALOIDS PROPRIETARY LTDInactiveBUPRENORPHINE BASE DRUG SUBSTANCE

DMF 151262000

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Dec 29, 2025	SUPPL -12	View Letter (PDF)
Sep 4, 2025	SUPPL -11	View Letter (PDF)
Apr 9, 2025	SUPPL -8	View Letter (PDF)
Dec 19, 2023	SUPPL -4	View Letter (PDF)
May 23, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (7)

Sort:

#001 — 8MG/0.16ML (50MG/ML)

RLD

8 patents1 exclusivity▴

SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | Approved: May 23, 2023

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8236292	Jan 10, 2027	—	—	Yes		—
8236755	Jul 31, 2026	—	—	Yes		—
9937164	Jul 26, 2032	—	—	Yes		—
10912772	Jul 26, 2032	—	—	—		—
11110084	Jul 26, 2032	—	—	Yes		—
11135215	Jul 26, 2032	—	—	Yes	—	—
12161640	Jul 26, 2032	—	—	Yes		—
12318379	Jul 26, 2032	—	—	Yes		—

Exclusivities (1)

Code	Date	Status
NP	May 23, 2026	Expired

#002 — 16MG/0.32ML (50MG/ML)

RLD

8 patents1 exclusivity▾

SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | Approved: May 23, 2023

#003 — 24MG/0.48ML (50MG/ML)

RLD

8 patents1 exclusivity▾

SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | Approved: May 23, 2023

#004 — 32MG/0.64ML (50MG/ML)

RLD

8 patents1 exclusivity▾

SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | Approved: May 23, 2023

#005 — 64MG/0.18ML (356MG/ML)

RLD

8 patents1 exclusivity▾

SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | Approved: May 23, 2023

#006 — 96MG/0.27ML (356MG/ML)

RLD

8 patents1 exclusivity▾

SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | Approved: May 23, 2023

#007 — 128MG/0.36ML (356MG/ML)

RLD

8 patents1 exclusivity▾

SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | Approved: May 23, 2023