Is There a Generic for Lumryz?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Lumryz (sodium oxybate). The Orange Book shows its last listed patent expires March 16, 2042 and its last listed exclusivity ends October 16, 2031.

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Lumryz products in the Orange Book

Lumryz products and approved generics
Form and route	Strength	Brand status	Brand TE	Generic TE codes
for suspension, extended release, oral	4.5GM/PACKET	Marketed (Rx)	None	None
for suspension, extended release, oral	6GM/PACKET	Marketed (Rx)	None	None
for suspension, extended release, oral	7.5GM/PACKET	Marketed (Rx)	None	None
for suspension, extended release, oral	9GM/PACKET	Marketed (Rx)	None	None

NDA 214755, held by ALKERMES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Lumryz patents

Patents listed for Lumryz
Patent	Expires	Covers	Use code	NDA
12303478	July 21, 2037	Method of use	U-4189	214755
11602513	July 21, 2037	Method of use	U-3576	214755
11602512	July 21, 2037	Method of use	U-3577	214755
11400065	July 21, 2037	Method of use	U-3579	214755
11000498	July 21, 2037	Drug product	U-3580	214755
12128021	July 21, 2037	Method of use	U-4022	214755
11986451	July 21, 2037	Method of use	U-3934	214755
10952986	July 21, 2037	Method of use	U-3601	214755
12097176	July 21, 2037	Method of use	U-4006	214755
11896572	July 21, 2037	Drug product	None	214755
10272062	July 21, 2037	Drug product	None	214755
11504347	July 21, 2037	Drug product	None	214755
12109186	July 21, 2037	Drug product	None	214755
11839597	July 21, 2037	Drug product	None	214755
12097175	July 21, 2037	Drug product	None	214755
12115144	July 21, 2037	Drug product	None	214755
12144793	July 21, 2037	Drug product	None	214755
11052061	July 21, 2037	Drug product	None	214755
12115143	July 21, 2037	Drug product	None	214755
12115142	July 21, 2037	Drug product	None	214755
11065224	July 21, 2037	Drug product	None	214755
12138239	July 21, 2037	Drug product	None	214755
10973795	July 21, 2037	Drug product	None	214755
11766418	July 21, 2037	Drug product	None	214755
12115145	July 21, 2037	Drug product	None	214755
10736866	July 21, 2037	Drug product	None	214755
12728110	July 21, 2037	Drug product	None	214755
11826335	July 21, 2037	Method of use	U-3751	214755
11583510	February 7, 2042	Method of use	U-3578	214755
11779557	March 16, 2042	Method of use	U-3705	214755

Lumryz exclusivity

Exclusivity listed for Lumryz
Code	Meaning	Expires	NDA
NP	New product	May 1, 2026	214755
ODE-431	Orphan drug exclusivity	May 1, 2030	214755
ODE-494	Orphan drug exclusivity	October 16, 2031	214755

Lumryz NDC codes

Questions

Is there a generic for Lumryz?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Lumryz (sodium oxybate). The Orange Book shows its last listed patent expires March 16, 2042 and its last listed exclusivity ends October 16, 2031.

What is the generic name for Lumryz?

The active ingredient in Lumryz is sodium oxybate, per the FDA Orange Book.

When does the Lumryz patent expire?

The last patent listed for Lumryz in the Orange Book expires March 16, 2042. 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.