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FDA Orange Book · active-ingredient family

Testosterone

Testosterone is approved as 13 brand and 26 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:NATESTO · NDA 205488

13

Brand (NDA)

26

Generics (ANDA)

19

Listed patents

0

Exclusivity periods

Brand (NDA) products · film, extended release, gel, gel, metered, injectable, pellet, solution, metered, tablet, extended release

ProductApplicantApplicationTEApproved
NATESTORLDACERUSNDA 205488—May 28, 2014
ANDRODERMRLD×4ABBVIENDA 020489—Oct 20, 2011
ANDROGELRLD×3BESINS HLTHCARENDA 022309ABApr 29, 2011
FORTESTARLDENDO OPERATIONSNDA 021463—Dec 29, 2010
AXIRONRLDELI LILLY AND CONDA 022504—Nov 23, 2010
ANDROGELRLD×3BESINS HLTHCARENDA 021015AB1Sep 26, 2003
STRIANTRLDAUXILIUM PHARMS LLCNDA 021543—Jun 19, 2003
TESTIMRLDENDO OPERATIONSNDA 021454AB2Oct 31, 2002
VOGELXO×2UPSHER SMITH LABSNDA 204399BXJun 04, 2014
TESTOSTERONE×3PERRIGO ISRAELNDA 203098—Jan 31, 2013
TESTOSTERONE×2ANI PHARMSNDA 202763—Feb 14, 2012
TESTODERM TTSALZANDA 020791—Dec 18, 1997
TESTODERM×2ALZANDA 019762—Oct 12, 1993

Generic (ANDA) products (26)

ProductApplicantApplicationTEApproved
TESTOSTERONE×3ENCUBEANDA 212984AB1Feb 09, 2024
TESTOSTERONETWI PHARMSANDA 209836—Sep 03, 2021
TESTOSTERONEALEMBICANDA 212882—Jun 14, 2021
TESTOSTERONEALEMBICANDA 213922—Mar 03, 2021
TESTOSTERONEENCUBEANDA 212301—Jan 11, 2021
TESTOSTERONEAPOTEXANDA 209181—Nov 25, 2020
TESTOSTERONEXIROMEDANDA 210835ABApr 16, 2020
TESTOSTERONETWI PHARMSANDA 209390—Sep 23, 2019
TESTOSTERONE×3ACTAVIS LABS UT INCANDA 204570ABApr 10, 2019
TESTOSTERONEAMNEALANDA 207373ABApr 10, 2019
TESTOSTERONEENCUBEANDA 208620ABApr 10, 2019
TESTOSTERONELUPINANDA 208560ABApr 10, 2019
TESTOSTERONECIPLAANDA 209533ATJan 29, 2018
TESTOSTERONELUPINANDA 208061ATOct 23, 2017
TESTOSTERONEACTAVIS LABS UT INCANDA 091073AB2Sep 18, 2017
TESTOSTERONEACTAVIS LABS UT INCANDA 205328ATAug 07, 2017
TESTOSTERONE×2PADAGIS ISRAELANDA 205781AB2Jul 12, 2017
TESTOSTERONEPADAGIS ISRAELANDA 204255ATFeb 28, 2017
TESTOSTERONEACTAVIS LABS UT INCANDA 204571—Aug 05, 2015
TESTOSTERONEPADAGIS ISRAELANDA 204268ABAug 04, 2015
TESTOSTERONE×3ACTAVIS LABS UT INCANDA 076737AB1Mar 09, 2015
TESTOSTERONE×2STRIDES PHARMA INTLANDA 076744AB1May 23, 2007
TESTOSTERONEWATSON LABSANDA 086419—Aug 23, 1983
TESTOSTERONEDR REDDYSANDA 086417—Jul 07, 1983
TESTOSTERONEWATSON LABSANDA 086420—May 10, 1983
TESTOPELENDO OPERATIONSANDA 080911—Approved Prior to Jan 1, 1982

Listed patents (19)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9180194Jun 02, 202617 d ago
U-1390
8993520Jun 02, 202617 d ago
U-1390
8466138Oct 12, 2026in 4 mo
U-1103
8466137Oct 12, 2026in 4 mo
U-1103
8741881Oct 12, 2026in 4 mo
U-1103
8729057Oct 12, 2026in 4 mo
Product
8759329Oct 12, 2026in 4 mo
Product
8754070Oct 12, 2026in 4 mo
Product
8466136Oct 12, 2026in 4 mo
Product
8486925Oct 12, 2026in 4 mo
Product
8807861Feb 26, 2027in 8 mo
ProductU-1563
9289586Feb 26, 2027in 8 mo
U-1390
8419307Feb 26, 2027in 8 mo
U-1386
8435944Sep 27, 2027in 1 yr 4 mo
U-1390
8785426Feb 11, 2034in 7 yr 9 mo
ProductU-1531
9662340Feb 11, 2034in 7 yr 9 mo
ProductU-1531
9295675Feb 11, 2034in 7 yr 9 mo
ProductU-1531
11744838Mar 17, 2034in 7 yr 10 mo
U-4366
11090312Mar 17, 2034in 7 yr 10 mo
U-1616

Testosterone — frequently asked questions

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

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