Is there a generic for Testosterone cypionate?

Yes. The FDA Orange Book lists 16 approved generic (ANDA) applications for Testosterone cypionate, referencing the brand AZMIRO. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Testosterone cypionate?

AZMIRO (NDA 216318, AZURITY) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Testosterone cypionate?

The Orange Book lists 3 patents against Testosterone cypionate products, with the earliest listed expiry in 2039. 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 cypionate are approved?

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

FDA Orange Book · active-ingredient family

Testosterone cypionate

Testosterone cypionate: 1 brand, 16 generics; first approved Jan 31, 2005; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 16 ANDA applications approved.

Earliest patent expiry Mar 25, 2039

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Mar 25, 2039

in 12 yr 8 mo

Brand (NDA) products

Originator applications

AZMIRORLDRS
AZURITYNDA 2163182022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG/ML (200MG/ML) SOLUTION INTRAMUSCULAR Rx —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/ML (200MG/ML)	SOLUTION	INTRAMUSCULAR	Rx	—

Generic (ANDA) products (16)

Abbreviated applications

TESTOSTERONE CYPIONATE
BPI LABSANDA 2194782026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG/ML INJECTABLE INJECTION Rx AO
TESTOSTERONE CYPIONATE
EUGIA PHARMAANDA 21181720232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/ML INJECTABLE INJECTION Rx AO
200MG/ML INJECTABLE INJECTION Rx AO
TESTOSTERONE CYPIONATE
XIROMEDANDA 21535120232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/ML INJECTABLE INJECTION Rx AO
200MG/ML INJECTABLE INJECTION Rx AO
TESTOSTERONE CYPIONATE
WILSHIRE PHARMS INCANDA 2063682019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG/ML INJECTABLE INJECTION Rx AO
TESTOSTERONE CYPIONATE
CIPLAANDA 21036220182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/ML INJECTABLE INJECTION Rx AO
200MG/ML INJECTABLE INJECTION Rx AO
TESTOSTERONE CYPIONATE
AM REGENTANDA 2077422017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG/ML INJECTABLE INJECTION Rx AO
TESTOSTERONE CYPIONATE
SUN PHARM INDS LTDANDA 20172020132 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/ML INJECTABLE INJECTION Discontinued —
200MG/ML INJECTABLE INJECTION Discontinued —
TESTOSTERONE CYPIONATE
HIKMA FARMACEUTICAANDA 0912442012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG/ML INJECTABLE INJECTION Rx AO
TESTOSTERONE CYPIONATE
HIKMAANDA 09038720102 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/ML INJECTABLE INJECTION Rx AO
200MG/ML INJECTABLE INJECTION Rx AO
TESTOSTERONE CYPIONATE
RISINGANDA 0406522006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG/ML INJECTABLE INJECTION Discontinued —
TESTOSTERONE CYPIONATE
CAPLIN ONE LABSANDA 04061520062 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/ML INJECTABLE INJECTION Discontinued —
200MG/ML INJECTABLE INJECTION Discontinued —
TESTOSTERONE CYPIONATE
PADAGIS USANDA 0405302005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG/ML INJECTABLE INJECTION Rx AO
DEPO-TESTOSTERONERLDRS
PFIZERANDA 085635—3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Discontinued —
100MG/ML INJECTABLE INJECTION Rx AO
200MG/ML INJECTABLE INJECTION Rx AO
TESTOSTERONE CYPIONATE
WATSON LABSANDA 084401—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/ML INJECTABLE INJECTION Discontinued —
200MG/ML INJECTABLE INJECTION Discontinued —
TESTOSTERONE CYPIONATE
WATSON LABSANDA 086029—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/ML INJECTABLE INJECTION Discontinued —
TESTOSTERONE CYPIONATE
WATSON PHARMS INCANDA 086030—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG/ML INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/ML	INJECTABLE	INJECTION	Rx	AO

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/ML	INJECTABLE	INJECTION	Rx	AO
200MG/ML	INJECTABLE	INJECTION	Rx	AO

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/ML	INJECTABLE	INJECTION	Rx	AO
200MG/ML	INJECTABLE	INJECTION	Rx	AO

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/ML	INJECTABLE	INJECTION	Rx	AO

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/ML	INJECTABLE	INJECTION	Rx	AO
200MG/ML	INJECTABLE	INJECTION	Rx	AO

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/ML	INJECTABLE	INJECTION	Rx	AO

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/ML	INJECTABLE	INJECTION	Discontinued	—
200MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/ML	INJECTABLE	INJECTION	Rx	AO

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/ML	INJECTABLE	INJECTION	Rx	AO
200MG/ML	INJECTABLE	INJECTION	Rx	AO

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/ML	INJECTABLE	INJECTION	Discontinued	—
200MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/ML	INJECTABLE	INJECTION	Rx	AO

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Discontinued	—
100MG/ML	INJECTABLE	INJECTION	Rx	AO
200MG/ML	INJECTABLE	INJECTION	Rx	AO

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/ML	INJECTABLE	INJECTION	Discontinued	—
200MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/ML	INJECTABLE	INJECTION	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12138271	Mar 25, 2039	in 12 yr 8 mo	Product
11642355	Mar 25, 2039	in 12 yr 8 mo	Product
11311554	Mar 25, 2039	in 12 yr 8 mo	Product

Approval history

FDA approval span

First approval

Jan 31, 2005

21 yr 11 mo ago

Most recent approval

Sep 03, 2026

19 d ago

Approvals span 2005–2026 across 17 FDA applications.

Brand (NDA) 16%

Generic (ANDA) 1694%

Testosterone cypionate: frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Related FDA reference tools

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo