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FDA Orange Book · active-ingredient family

Risedronate sodium

Risedronate sodium is approved as 2 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ATELVIA · NDA 022560

2

Brand (NDA)

14

Generics (ANDA)

3

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet, tablet, delayed release

ProductApplicantApplicationTEApproved
ATELVIARLDAPILNDA 022560ABOct 08, 2010
ACTONELRLD×5APILNDA 020835—Apr 14, 2000

Generic (ANDA) products (14)

ProductApplicantApplicationTEApproved
RISEDRONATE SODIUMSUN PHARMANDA 203925—Jul 09, 2019
RISEDRONATE SODIUM×2ORBION PHARMSANDA 205280ABMay 13, 2019
RISEDRONATE SODIUMHANGZHOU BINJIANGANDA 207516—Feb 15, 2019
RISEDRONATE SODIUMZYDUS PHARMSANDA 203822—Sep 11, 2018
RISEDRONATE SODIUMIMPAX LABS INCANDA 205066—Jun 29, 2018
RISEDRONATE SODIUMAUROBINDO PHARMAANDA 206768ABOct 21, 2016
RISEDRONATE SODIUM×3MACLEODS PHARMS LTDANDA 203533ABDec 09, 2015
RISEDRONATE SODIUM×3APOTEXANDA 090877ABNov 30, 2015
RISEDRONATE SODIUM×3AUROBINDO PHARMA LTDANDA 200296ABNov 30, 2015
RISEDRONATE SODIUM×5PHARMOBEDIENTANDA 200477—Nov 30, 2015
RISEDRONATE SODIUM×5SUN PHARMANDA 090886ABNov 30, 2015
RISEDRONATE SODIUMTEVA PHARMS USAANDA 203217ABMay 18, 2015
RISEDRONATE SODIUMTEVA PHARMS USAANDA 079215ABJun 13, 2014
RISEDRONATE SODIUM×3TEVA PHARMS USAANDA 077132ABOct 05, 2007

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8246989Jan 16, 20265 mo ago
Product
7645460Jan 09, 2028in 1 yr 7 mo
ProductU-662
7645459Jan 09, 2028in 1 yr 7 mo
ProductU-662

Risedronate sodium — frequently asked questions

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

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