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FDA Orange Book · active-ingredient family

Testosterone cypionate

Testosterone cypionate is approved as 1 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:AZMIRO · NDA 216318

1

Brand (NDA)

15

Generics (ANDA)

3

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, solution

ProductApplicantApplicationTEApproved
AZMIRORLDAZURITYNDA 216318—Jun 02, 2022

Generic (ANDA) products (15)

ProductApplicantApplicationTEApproved
TESTOSTERONE CYPIONATE×2EUGIA PHARMAANDA 211817AOOct 20, 2023
TESTOSTERONE CYPIONATE×2XIROMEDANDA 215351AOApr 13, 2023
TESTOSTERONE CYPIONATEWILSHIRE PHARMS INCANDA 206368AOApr 24, 2019
TESTOSTERONE CYPIONATE×2CIPLAANDA 210362AOJun 19, 2018
TESTOSTERONE CYPIONATEAM REGENTANDA 207742AOJun 16, 2017
TESTOSTERONE CYPIONATE×2SUN PHARM INDS LTDANDA 201720—Jun 03, 2013
TESTOSTERONE CYPIONATEHIKMA FARMACEUTICAANDA 091244AOMay 01, 2012
TESTOSTERONE CYPIONATE×2HIKMAANDA 090387AOJul 15, 2010
TESTOSTERONE CYPIONATERISINGANDA 040652—Dec 11, 2006
TESTOSTERONE CYPIONATE×2CAPLIN ONE LABSANDA 040615—Aug 10, 2006
TESTOSTERONE CYPIONATEPADAGIS USANDA 040530AOJan 31, 2005
DEPO-TESTOSTERONERLD×3PFIZERANDA 085635AOApproved Prior to Jan 1, 1982
TESTOSTERONE CYPIONATE×2WATSON LABSANDA 084401—Approved Prior to Jan 1, 1982
TESTOSTERONE CYPIONATEWATSON LABSANDA 086029—Approved Prior to Jan 1, 1982
TESTOSTERONE CYPIONATEWATSON PHARMS INCANDA 086030—Approved Prior to Jan 1, 1982

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
12138271Mar 25, 2039in 12 yr 11 mo
Product
11642355Mar 25, 2039in 12 yr 11 mo
Product
11311554Mar 25, 2039in 12 yr 11 mo
Product

Testosterone cypionate — frequently asked questions

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

Agent CTA Background

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