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FDA Orange Book · active-ingredient family

Alendronate sodium

Alendronate sodium is approved as 3 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:BINOSTO · NDA 202344

3

Brand (NDA)

16

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · solution, tablet, tablet, effervescent

ProductApplicantApplicationTEApproved
BINOSTORLDRADIUSNDA 202344—Mar 12, 2012
FOSAMAXRLDMERCKNDA 021575—Sep 17, 2003
FOSAMAXRLD×5ORGANONNDA 020560—Apr 25, 1997

Generic (ANDA) products (16)

ProductApplicantApplicationTEApproved
ALENDRONATE SODIUM×4IPCA LABS LTDANDA 206387ABJun 04, 2024
ALENDRONATE SODIUMNOVITIUM PHARMAANDA 214512AAMay 11, 2023
ALENDRONATE SODIUMHIKMAANDA 090520AAFeb 25, 2013
ALENDRONATE SODIUM×4JUBILANT CADISTAANDA 090557—Feb 18, 2010
ALENDRONATE SODIUM×4HANGZHOU BINJIANGANDA 090258ABSep 24, 2009
ALENDRONATE SODIUM×5CHARTWELL RXANDA 075871—Apr 22, 2009
ALENDRONATE SODIUM×4SUN PHARMANDA 090022ABSep 10, 2008
ALENDRONATE SODIUM×4APOTEXANDA 077982—Aug 04, 2008
ALENDRONATE SODIUM×3AUROBINDO PHARMAANDA 090124ABAug 04, 2008
ALENDRONATE SODIUM×4CHARTWELL RXANDA 079049—Aug 04, 2008
ALENDRONATE SODIUM×5CIPLAANDA 076768ABAug 04, 2008
ALENDRONATE SODIUM×2MYLANANDA 078638—Aug 04, 2008
ALENDRONATE SODIUM×4RISINGANDA 076584—Aug 04, 2008
ALENDRONATE SODIUM×2TEVA PHARMSANDA 076184—Aug 04, 2008
ALENDRONATE SODIUM×3WATSON LABSANDA 076984ABAug 04, 2008
ALENDRONATE SODIUM×5IMPAX LABS INCANDA 075710—Feb 06, 2008

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9592195Dec 05, 2031in 5 yr 7 mo
Product

Alendronate sodium — frequently asked questions

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

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