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FDA Orange Book · active-ingredient family

Amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate

Amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate is approved as 3 brand and 41 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:MYDAYIS · NDA 022063

3

Brand (NDA)

41

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, extended release, tablet

ProductApplicantApplicationTEApproved
MYDAYISRLD×4TAKEDA PHARMS USANDA 022063AB2Jun 20, 2017
ADDERALL XR 10RLD×6TAKEDA PHARMS USANDA 021303AB1Oct 11, 2001
ADDERALL 10RLD×7TEVA WOMENSNDA 011522—Feb 13, 1996

Generic (ANDA) products (41)

ProductApplicantApplicationTEApproved
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×6LUPINANDA 214777AB1Nov 07, 2024
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×7ALKEM LABS LTDANDA 217787ABOct 06, 2023
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×4SUN PHARM INDS INCANDA 215997AB2Sep 27, 2023
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×4SPECGX LLCANDA 211546AB2Aug 31, 2023
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×6GRANULESANDA 217027AB1Jan 23, 2023
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×7LANNETT CO INCANDA 215565ABJul 08, 2022
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×5CEDIPROF INCANDA 210754ABJul 05, 2022
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×4TEVA PHARMS USAANDA 210876AB2Jan 31, 2022
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×7GRANULESANDA 215771ABDec 28, 2021
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×6LANNETT CO INCANDA 214403AB1Nov 26, 2021
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×7ACCORD HLTHCAREANDA 214347—Nov 22, 2021
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×6ASCENT PHARMS INCANDA 214959AB1Sep 29, 2021
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×7ASCENT PHARMS INCANDA 213709ABApr 22, 2021
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×7RHODES PHARMSANDA 213111ABJan 13, 2021
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×6AUROLIFE PHARMA LLCANDA 211876—Jun 24, 2020
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×6ORYZAANDA 210293ABApr 03, 2020
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×6ELITE LABS INCANDA 212037AB1Dec 11, 2019
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×6NESHER PHARMSANDA 210080—Jul 17, 2019
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×6PH HEALTHANDA 206159—May 31, 2019
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×6RHODES PHARMSANDA 210651AB1May 17, 2019
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×6SUN PHARM INDUSTRIESANDA 211715—May 17, 2019
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×6SPECGX LLCANDA 211547AB1Apr 22, 2019
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×6ANI PHARMSANDA 205401AB1Jan 22, 2019
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×7ELITE LABS INCANDA 211352ABDec 07, 2018
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×7NUVO PHARMANDA 209799ABDec 28, 2017
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×7ZYDUS PHARMSANDA 207340ABOct 31, 2017
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×7ALVOGENANDA 207388ABJul 28, 2017
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×6IMPAX LABSANDA 076852AB1Feb 16, 2016
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×7ACTAVIS ELIZABETHANDA 206340ABFeb 05, 2016
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×7COREPHARMAANDA 206721—Nov 10, 2015
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×7AUROLIFE PHARMA LLCANDA 202424ABNov 27, 2013
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×6TEVAANDA 077488—Apr 29, 2013
DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE×6BARR LABS INCANDA 076536—Feb 12, 2013
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×6ACTAVIS ELIZABETHANDA 077302AB1Jun 22, 2012
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×7SPECGX LLCANDA 040440ABOct 07, 2003
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×4TEVA PHARMSANDA 040472—Sep 30, 2003
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×7SUN PHARM INDUSTRIESANDA 040480ABSep 09, 2003
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×4ACTAVIS ELIZABETHANDA 040456—May 06, 2003
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×4SANDOZANDA 040439ABSep 27, 2002
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×7EPIC PHARMA LLCANDA 040444ABJun 19, 2002
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE×7BARRANDA 040422ABFeb 11, 2002

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9173857May 12, 20261 mo ago
U-2025
8846100Aug 24, 2029in 3 yr 3 mo
Product

Amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate — frequently asked questions

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

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