FDA Orange Book

Generic for Vogelxo

Vogelxo contains testosterone. 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 Vogelxo is testosterone. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.

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Vogelxo products in the Orange Book

Vogelxo products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
gel, metered, transdermal	12.5MG/1.25GM ACTUATION	Marketed (Rx)	BX	2	AB1
gel, transdermal	50MG/5GM PACKET	Marketed (Rx)	AB2	4	AB1, AB2

NDA 204399, held by UPSHER SMITH LABORATORIES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic testosterone

Approved generic versions of Vogelxo
Company	ANDA	TE code	Approved	Strengths
STRIDES PHARMA INTERNATIONAL AG	076744	AB1 (A-rated, therapeutically equivalent)	May 23, 2007	50MG/5GM PACKET
ACTAVIS LABORATORIES UT INC	076737	AB1 (A-rated, therapeutically equivalent)	March 9, 2015	12.5MG/1.25GM ACTUATION, 50MG/5GM PACKET
ACTAVIS LABORATORIES UT INC	091073	AB2 (A-rated, therapeutically equivalent)	September 18, 2017	50MG/5GM PACKET
ENCUBE ETHICALS PRIVATE LTD	212984	AB1 (A-rated, therapeutically equivalent)	February 9, 2024	12.5MG/1.25GM ACTUATION, 50MG/5GM PACKET

Vogelxo patents

Patents listed for Vogelxo
Patent	Expires	Covers	Use code	NDA
8785426	February 11, 2034	Drug product	U-1531	204399
9662340	February 11, 2034	Drug product	U-1531	204399
9295675	February 11, 2034	Drug product	U-1531	204399

Vogelxo NDC codes

Questions

Is there a generic for Vogelxo?

Yes. The generic name for Vogelxo is testosterone. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.

What is the generic name for Vogelxo?

The active ingredient in Vogelxo is testosterone, per the FDA Orange Book.

When does the Vogelxo patent expire?

The last patent listed for Vogelxo in the Orange Book expires February 11, 2034. 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.