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FDA Orange Book · active-ingredient family

Vardenafil hydrochloride

Vardenafil hydrochloride is approved as 2 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:STAXYN · NDA 200179

2

Brand (NDA)

8

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet, tablet, orally disintegrating

ProductApplicantApplicationTEApproved
STAXYNRLDBAYER HLTHCARENDA 200179—Jun 17, 2010
LEVITRARLD×4BAYER HLTHCARENDA 021400—Aug 19, 2003

Generic (ANDA) products (8)

ProductApplicantApplicationTEApproved
VARDENAFIL HYDROCHLORIDE×4ALEMBICANDA 214031ABAug 04, 2020
VARDENAFIL HYDROCHLORIDEMACLEODS PHARMS LTDANDA 205988ABMar 10, 2020
VARDENAFIL HYDROCHLORIDE×4MACLEODS PHARMS LTDANDA 204632ABOct 22, 2019
VARDENAFIL HYDROCHLORIDEALEMBICANDA 208324ABNov 16, 2018
VARDENAFIL HYDROCHLORIDE×4CROSSMEDIKA SAANDA 209057ABOct 31, 2018
VARDENAFIL HYDROCHLORIDE×3STEVENS JANDA 210738—Oct 31, 2018
VARDENAFIL HYDROCHLORIDE×4ZYDUS PHARMSANDA 208960ABOct 31, 2018
VARDENAFIL HYDROCHLORIDE×4TEVA PHARMSANDA 091347ABMay 03, 2012

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8273876Jul 23, 2027in 1 yr 1 mo
U-1288
8613950Dec 23, 2028in 2 yr 7 mo
Product

Vardenafil hydrochloride — frequently asked questions

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

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