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BUPRENORPHINE

ANDA

BUPRENORPHINE | A204937 | WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

5 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: BUTRANS(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 5 NDCs

Highest NADAC/Unit

$57.32

per ea

Lowest NADAC/Unit

$23.82

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00093365940BUPRENORPHINE 20 MCG/HR PATCH	$57.32	EA	Generic	—	2026-08-19
00093365840BUPRENORPHINE 15 MCG/HR PATCH	$52.70	EA	Generic	—	2026-08-19
00093323940BUPRENORPHINE 7.5 MCG/HR PATCH	$37.85	EA	Generic	—	2026-08-19
00093365740BUPRENORPHINE 10 MCG/HR PATCH	$33.75	EA	Generic	—	2026-08-19
00093365640BUPRENORPHINE 5 MCG/HR PATCH	$23.82	EA	Generic	—	2026-08-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 5 NDCs (5 FSS)

Lowest Price

$41.96

Highest Price

$109.64

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00093-3239-40BUPRENORPHINE 7.5MCG/HR PATCH	$66.05	FSS	AvKare, LLC	06/14/2028
00093-3656-40BUPRENORPHINE 5MCG/HR PATCH	$41.96	FSS	AvKare, LLC	06/14/2028
00093-3657-40BUPRENORPHINE 10MCG/HR PATCH	$58.40	FSS	AvKare, LLC	06/14/2028
00093-3658-40BUPRENORPHINE 15MCG/HR PATCH	$89.80	FSS	AvKare, LLC	06/14/2028
00093-3659-40BUPRENORPHINE 20MCG/HR PATCH	$109.64	FSS	AvKare, LLC	06/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain11 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

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

1 letter from Drugs@FDA

Date	Submission	Document
Dec 20, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 5MCG/HR

0 patents0 exclusivities▴

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Nov 20, 2018

No patent or exclusivity listings for this strength.

#002 — 10MCG/HR

0 patents0 exclusivities▾

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Nov 20, 2018

#003 — 15MCG/HR

0 patents0 exclusivities▾

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Nov 20, 2018

#004 — 20MCG/HR

0 patents0 exclusivities▾

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Nov 20, 2018

#005 — 7.5MCG/HR

0 patents0 exclusivities▾

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Jun 29, 2021