Is there a generic for Testosterone enanthate?

Yes. The FDA Orange Book lists 7 approved generic (ANDA) applications for Testosterone enanthate, referencing the brand XYOSTED (AUTOINJECTOR). Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Testosterone enanthate?

XYOSTED (AUTOINJECTOR) (NDA 209863, ANTARES PHARMA INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Testosterone enanthate?

The Orange Book lists 24 patents against Testosterone enanthate products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Testosterone enanthate are approved?

Testosterone enanthate is approved in the following dosage forms: injectable, solution.

FDA Orange Book · active-ingredient family

Testosterone enanthate

Testosterone enanthate is approved as 2 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:XYOSTED (AUTOINJECTOR) · NDA 209863

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable, solution

Product	Applicant	Application	TE	Approved
XYOSTED (AUTOINJECTOR)RLD×3	ANTARES PHARMA INC	NDA 209863	—	Sep 28, 2018
DELATESTRYLRLD×2	ENDO PHARMS	NDA 009165	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (7)

Product	Applicant	Application	TE	Approved
TESTOSTERONE ENANTHATE	EUGIA PHARMA	ANDA 212659	AO	Feb 28, 2024
TESTOSTERONE ENANTHATE	HIKMA FARMACEUTICA	ANDA 091120	AO	Sep 18, 2012
TESTOSTERONE ENANTHATE	RISING	ANDA 040647	—	Oct 05, 2009
TESTOSTERONE ENANTHATE	NEXUS	ANDA 040575	AO	Jun 14, 2006
TESTOSTERONE ENANTHATE×2	WATSON LABS	ANDA 083667	—	Approved Prior to Jan 1, 1982
TESTOSTERONE ENANTHATE	WATSON LABS	ANDA 085599	—	Approved Prior to Jan 1, 1982
TESTOSTERONE ENANTHATE	WATSON PHARMS INC	ANDA 085598	—	Approved Prior to Jan 1, 1982

Listed patents (24)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11446441	Jan 24, 2026	5 mo ago	Product
9533102	Jan 24, 2026	5 mo ago	Product
9180259	Jan 24, 2026	5 mo ago	Product
9629959	Jan 24, 2026	5 mo ago	Product
10478560	Jan 24, 2026	5 mo ago	Product
8562564	Jan 24, 2026	5 mo ago	Product
8021335	Oct 04, 2026	in 4 mo	Product
11497753	Mar 19, 2030	in 3 yr 10 mo	Product
10279131	Jul 31, 2031	in 5 yr 2 mo	Product
10357609	Aug 21, 2031	in 5 yr 3 mo	Product
10905827	Aug 21, 2031	in 5 yr 3 mo	Product
11446440	Aug 21, 2031	in 5 yr 3 mo	Product
11844804	Jun 04, 2033	in 7 yr 1 mo	U-2418
10821072	Jun 04, 2033	in 7 yr 1 mo	ProductU-2418
10881798	Feb 11, 2034	in 7 yr 9 mo	Product
11160751	Oct 07, 2034	in 8 yr 5 mo	ProductU-2418
10912782	Feb 19, 2035	in 8 yr 10 mo	ProductU-2418
10238662	Feb 19, 2035	in 8 yr 10 mo	ProductU-2418
11813435	Feb 25, 2035	in 8 yr 10 mo	Product
12629483	Aug 07, 2035	in 9 yr 3 mo	Product
11191908	Oct 18, 2035	in 9 yr 6 mo	Product
9744302	Nov 19, 2035	in 9 yr 7 mo	Product
9950125	Sep 04, 2036	in 10 yr 4 mo	ProductU-2418
10646495	Aug 30, 2038	in 12 yr 5 mo	Product

Testosterone enanthate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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