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Last Updated: November 4, 2024

DEXTROAMPHETAMINE SULFATE - Generic Drug Details


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What are the generic drug sources for dextroamphetamine sulfate and what is the scope of patent protection?

Dextroamphetamine sulfate is the generic ingredient in six branded drugs marketed by Impax Labs Inc, Able, Actavis Elizabeth, Dr Reddys Labs Sa, Nesher Pharms, Norvium Bioscience, Specgx Llc, Strides Pharma, Teva, Glaxosmithkline, Prasco, Tris Pharma Inc, Ani Pharms, Aurolife Pharma Llc, Avanthi Inc, Azurity, Barr, Epic Pharma Llc, Halsey, Lannett, Mast Mm, Novel Labs Inc, Nuvo Pharm, Purepac Pharm, Sandoz, Vitarine, Winder Labs Llc, Shire, and Ferndale Labs, and is included in forty NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for dextroamphetamine sulfate. Sixteen suppliers are listed for this compound.

Summary for DEXTROAMPHETAMINE SULFATE
Drug Prices for DEXTROAMPHETAMINE SULFATE

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Recent Clinical Trials for DEXTROAMPHETAMINE SULFATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Vallon Pharmaceuticals, Inc.Phase 1
Medical University of ViennaN/A
Centre hospitalier de l'Université de Montréal (CHUM)Phase 2

See all DEXTROAMPHETAMINE SULFATE clinical trials

Pharmacology for DEXTROAMPHETAMINE SULFATE
Medical Subject Heading (MeSH) Categories for DEXTROAMPHETAMINE SULFATE

US Patents and Regulatory Information for DEXTROAMPHETAMINE SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurolife Pharma Llc DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET;ORAL 202893-002 Jul 31, 2013 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Tris Pharma Inc DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET;ORAL 206095-002 Aug 18, 2022 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Nesher Pharms DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET;ORAL 040367-001 Oct 31, 2002 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Shire DEXTROSTAT dextroamphetamine sulfate TABLET;ORAL 084051-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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