FDA Orange Book

Generic for Qsymia

Qsymia contains phentermine and topiramate. 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 Qsymia is phentermine and topiramate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Qsymia products in the Orange Book

Qsymia products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
capsule, extended release, oral	EQ 11.25MG BASE;69MG	Marketed (Rx)	AB	2	AB
capsule, extended release, oral	EQ 15MG BASE;92MG	Marketed (Rx)	AB	2	AB
capsule, extended release, oral	EQ 3.75MG BASE;23MG	Marketed (Rx)	AB	2	AB
capsule, extended release, oral	EQ 7.5MG BASE;46MG	Marketed (Rx)	AB	2	AB

NDA 022580, held by VIVUS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic phentermine and topiramate

Approved generic versions of Qsymia
Company	ANDA	TE code	Approved	Strengths
ACTAVIS LABORATORIES FL INC	204982	AB (A-rated, therapeutically equivalent)	June 25, 2024	EQ 11.25MG BASE;69MG, EQ 15MG BASE;92MG, EQ 3.75MG BASE;23MG, EQ 7.5MG BASE;46MG
DR REDDYS LABORATORIES SA	208175	AB (A-rated, therapeutically equivalent)	June 12, 2025	EQ 11.25MG BASE;69MG, EQ 15MG BASE;92MG, EQ 3.75MG BASE;23MG, EQ 7.5MG BASE;46MG

Qsymia patents

Patents listed for Qsymia
Patent	Expires	Covers	Use code	NDA
9011906	June 9, 2028	Method of use	U-3398	022580
8895057	June 9, 2028	Method of use	U-3398	022580
8895058	June 9, 2028	Drug product	None	022580
9011905	June 9, 2028	Drug product	None	022580
8580298	May 15, 2029	Drug product	None	022580
8580299	June 14, 2029	Method of use	U-3399	022580

Qsymia exclusivity

Exclusivity listed for Qsymia
Code	Meaning	Expires	NDA
M-308	Miscellaneous	September 13, 2027	022580

Qsymia NDC codes

Questions

Is there a generic for Qsymia?

Yes. The generic name for Qsymia is phentermine and topiramate. 2 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 Qsymia?

The active ingredient in Qsymia is phentermine and topiramate, per the FDA Orange Book.

When does the Qsymia patent expire?

The last patent listed for Qsymia in the Orange Book expires June 14, 2029. 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.