Is There a Generic for Brixadi?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Brixadi (buprenorphine). The Orange Book shows its last listed patent expires July 26, 2032 and its last listed exclusivity ends May 23, 2026.

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Brixadi products in the Orange Book

Brixadi products and approved generics
Form and route	Strength	Brand status	Brand TE	Generic TE codes
solution, extended release, subcutaneous	128MG/0.36ML (356MG/ML)	Marketed (Rx)	None	None
solution, extended release, subcutaneous	16MG/0.32ML (50MG/ML)	Marketed (Rx)	None	None
solution, extended release, subcutaneous	24MG/0.48ML (50MG/ML)	Marketed (Rx)	None	None
solution, extended release, subcutaneous	32MG/0.64ML (50MG/ML)	Marketed (Rx)	None	None
solution, extended release, subcutaneous	64MG/0.18ML (356MG/ML)	Marketed (Rx)	None	None
solution, extended release, subcutaneous	8MG/0.16ML (50MG/ML)	Marketed (Rx)	None	None
solution, extended release, subcutaneous	96MG/0.27ML (356MG/ML)	Marketed (Rx)	None	None

NDA 210136, held by BRAEBURN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Brixadi patents

Patents listed for Brixadi
Patent	Expires	Covers	Use code	NDA
8236755	July 31, 2026	Drug product	U-3620	210136
8236292	January 10, 2027	Drug product	U-3619	210136
12318379	July 26, 2032	Drug product	U-4100	210136
12161640	July 26, 2032	Drug product	U-4100	210136
11110084	July 26, 2032	Drug product	U-3616	210136
10912772	July 26, 2032	Method of use	U-3617	210136
9937164	July 26, 2032	Drug product	U-3618	210136
11135215	July 26, 2032	Drug product	None	210136

Brixadi exclusivity

Exclusivity listed for Brixadi
Code	Meaning	Expires	NDA
NP	New product	May 23, 2026	210136

Brixadi NDC codes

Questions

Is there a generic for Brixadi?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Brixadi (buprenorphine). The Orange Book shows its last listed patent expires July 26, 2032 and its last listed exclusivity ends May 23, 2026.

What is the generic name for Brixadi?

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

When does the Brixadi patent expire?

The last patent listed for Brixadi in the Orange Book expires July 26, 2032. 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.