Is there a generic for Buprenorphine hydrochloride; naloxone hydrochloride?

Yes. The FDA Orange Book lists 20 approved generic (ANDA) applications for Buprenorphine hydrochloride; naloxone hydrochloride, referencing the brand CASSIPA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Buprenorphine hydrochloride; naloxone hydrochloride?

CASSIPA (NDA 208042, TEVA PHARMS USA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Buprenorphine hydrochloride; naloxone hydrochloride?

The Orange Book lists 17 patents against Buprenorphine hydrochloride; naloxone hydrochloride products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

FDA Orange Book · active-ingredient family

Buprenorphine hydrochloride; naloxone hydrochloride

Buprenorphine hydrochloride; naloxone hydrochloride is approved as 5 brand and 20 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CASSIPA · NDA 208042

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · film, tablet

Product	Applicant	Application	TE	Approved
CASSIPARLD	TEVA PHARMS USA	NDA 208042	—	Sep 07, 2018
ZUBSOLVRLD×6	EDENBRIDGE PHARMS	NDA 204242	—	Oct 04, 2016
BUNAVAILRLD×3	BDSI	NDA 205637	—	Jun 06, 2014
SUBOXONERLD×4	INDIVIOR	NDA 022410	AB	Aug 30, 2010
SUBOXONERLD×2	INDIVIOR	NDA 020733	—	Oct 08, 2002

Generic (ANDA) products (20)

Product	Applicant	Application	TE	Approved
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE×4	ASCENT PHARMS INC	ANDA 219850	AB	Jan 21, 2026
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE×2	ASCENT PHARMS INC	ANDA 219727	AB	Dec 15, 2025
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE×4	DIFGEN PHARMS	ANDA 212756	AB	Feb 13, 2025
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE×2	ALKEM LABS LTD	ANDA 214930	AB	Jun 15, 2021
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE×2	DR REDDYS LABS SA	ANDA 206953	—	Jul 17, 2020
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE×2	WES PHARMA INC	ANDA 209069	AB	Jul 17, 2020
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE×2	MYLAN TECHNOLOGIES	ANDA 211785	AB	Apr 17, 2020
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE×2	RHODES PHARMS	ANDA 205601	AB	Mar 30, 2020
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE×4	ALVOGEN	ANDA 205954	AB	Jan 24, 2019
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE×2	DR REDDYS LABS SA	ANDA 205299	AB	Jun 14, 2018
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE×2	DR REDDYS LABS SA	ANDA 205806	AB	Jun 14, 2018
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE×2	MYLAN TECHNOLOGIES	ANDA 207607	AB	Jun 14, 2018
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE×2	SPECGX LLC	ANDA 207000	AB	Dec 13, 2017
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE×2	LANNETT CO INC	ANDA 205022	AB	Sep 19, 2016
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE×2	SUN PHARM	ANDA 201633	AB	Aug 05, 2016
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE×2	ETHYPHARM	ANDA 204431	AB	Oct 16, 2015
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE×2	TEVA PHARMS USA	ANDA 091149	—	Sep 08, 2014
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE×2	HIKMA	ANDA 203326	AB	Jun 27, 2014
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE×2	ACTAVIS ELIZABETH	ANDA 091422	AB	Feb 22, 2013
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE×2	AMNEAL PHARMS	ANDA 203136	AB	Feb 22, 2013

Listed patents (17)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9655843	Jul 23, 2027	in 1 yr 1 mo	ProductU-2017
8147866	Jul 23, 2027	in 1 yr 1 mo	ProductU-1521
8658198	Dec 03, 2027	in 1 yr 6 mo	ProductU-1494
9687454	Aug 07, 2029	in 3 yr 2 mo	ProductU-1464
11135216	Aug 07, 2029	in 3 yr 2 mo	ProductU-3111
8475832	Mar 26, 2030	in 3 yr 10 mo	ProductU-1411
8470361	May 22, 2030	in 4 yr	ProductU-1425
8703177	Aug 20, 2032	in 6 yr 3 mo	Product
11020388	Sep 18, 2032	in 6 yr 4 mo	ProductU-3131
10946010	Sep 18, 2032	in 6 yr 4 mo	Product
9259421	Sep 18, 2032	in 6 yr 4 mo	Product
8940330	Sep 18, 2032	in 6 yr 4 mo	Product
11433066	Sep 18, 2032	in 6 yr 4 mo	U-3131
9439900	Sep 18, 2032	in 6 yr 4 mo	Product
11020387	Sep 18, 2032	in 6 yr 4 mo	ProductU-3131
10874661	Sep 18, 2032	in 6 yr 4 mo	Product
9522188	Apr 24, 2035	in 9 yr	Product