FDA Orange Book

Generic for Butrans

Butrans contains buprenorphine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Butrans is buprenorphine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

Run it in Rivvi

Map Butrans and your other top fills to their generics

Every strength in RxNorm, with brands that have no generic flagged.

Build the map

Free to start. Opens Rivvi, the AI workspace for healthcare teams.

Butrans products in the Orange Book

Butrans products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
film, extended release, transdermal	10MCG/HR	Marketed (Rx)	AB	4	AB
film, extended release, transdermal	15MCG/HR	Marketed (Rx)	AB	4	AB
film, extended release, transdermal	20MCG/HR	Marketed (Rx)	AB	4	AB
film, extended release, transdermal	5MCG/HR	Marketed (Rx)	AB	4	AB
film, extended release, transdermal	7.5MCG/HR	Marketed (Rx)	AB	3	AB

NDA 021306, held by KNOA PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic buprenorphine

Approved generic versions of Butrans
Company	ANDA	TE code	Approved	Strengths
WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC	204937	AB (A-rated, therapeutically equivalent)	November 20, 2018	10MCG/HR, 15MCG/HR, 20MCG/HR, 5MCG/HR, 7.5MCG/HR
AMNEAL PHARMACEUTICALS LLC	211586	AB (A-rated, therapeutically equivalent)	April 14, 2020	10MCG/HR, 15MCG/HR, 20MCG/HR, 5MCG/HR, 7.5MCG/HR
DIFGEN PHARMACEUTICALS LLC	210272	AB (A-rated, therapeutically equivalent)	September 23, 2021	10MCG/HR, 15MCG/HR, 20MCG/HR, 5MCG/HR, 7.5MCG/HR
STRIDES PHARMA INTERNATIONAL AG	207490	AB (A-rated, therapeutically equivalent)	May 17, 2022	10MCG/HR, 15MCG/HR, 20MCG/HR, 5MCG/HR

Butrans NDC codes

Questions

Is there a generic for Butrans?

Yes. The generic name for Butrans is buprenorphine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Butrans?

The active ingredient in Butrans is buprenorphine, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.