Is There a Generic for Sublocade?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Sublocade (buprenorphine). The Orange Book shows its last listed patent expires June 22, 2038 and its last listed exclusivity ends February 21, 2028.

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Sublocade products in the Orange Book

Sublocade products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
solution, extended release, subcutaneous	100MG/0.5ML (100MG/0.5ML)	Marketed (Rx)	None	0	None
solution, extended release, subcutaneous	300MG/1.5ML (200MG/ML)	Marketed (Rx)	None	0	None

NDA 209819, held by INDIVIOR INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Sublocade patents

Patents listed for Sublocade
Patent	Expires	Covers	Use code	NDA
9827241	June 6, 2031	Drug product	U-2206	209819
9827241	June 6, 2031	Drug product	U-2211	209819
9827241	June 6, 2031	Drug product	U-2181	209819
9827241	June 6, 2031	Drug product	U-2210	209819
9782402	June 6, 2031	Drug product	U-2180	209819
9782402	June 6, 2031	Drug product	U-2176	209819
9782402	June 6, 2031	Drug product	U-2208	209819
9272044	June 6, 2031	Method of use	U-2176	209819
9272044	June 6, 2031	Method of use	U-2209	209819
9272044	June 6, 2031	Method of use	U-2178	209819
10198218	June 6, 2031	Method of use	U-2489	209819
9272044	June 6, 2031	Method of use	U-2177	209819
9498432	June 6, 2031	Drug product	U-2179	209819
9782402	June 6, 2031	Drug product	U-2207	209819
9827241	June 6, 2031	Drug product	U-2174	209819
10592168	June 6, 2031	Method of use	U-2489	209819
10558394	June 25, 2031	Drug product	None	209819
8975270	September 5, 2031	Drug product	U-2206	209819
8975270	September 5, 2031	Drug product	U-2175	209819
8921387	January 6, 2032	Drug product	U-2174	209819
8921387	January 6, 2032	Drug product	U-2173	209819
11000520	November 6, 2035	Method of use	U-3111	209819
11839611	November 6, 2035	Method of use	U-3111	209819
12622904	November 6, 2035	Method of use	U-4528	209819
10646484	June 22, 2038	Method of use	U-2489	209819

Sublocade exclusivity

Exclusivity listed for Sublocade
Code	Meaning	Expires	NDA
M-314	Miscellaneous	February 21, 2028	209819

Sublocade NDC codes

Questions

Is there a generic for Sublocade?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Sublocade (buprenorphine). The Orange Book shows its last listed patent expires June 22, 2038 and its last listed exclusivity ends February 21, 2028.

What is the generic name for Sublocade?

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

When does the Sublocade patent expire?

The last patent listed for Sublocade in the Orange Book expires June 22, 2038. A listed patent expiry date is not a generic launch date.

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.