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Last Updated: August 12, 2020

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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 five branded drugs marketed by Impax Labs Inc, Able, Actavis Elizabeth, Mayne Pharma, Mylan, Nesher Pharms, PII, Specgx Llc, Vintage Pharms, Teva, Glaxosmithkline, Outlook Pharms, Tris Pharma Inc, Ani Pharms Inc, Arbor Pharms Llc, Aurolife Pharma Llc, Avanthi Inc, Barr, Epic Pharma Llc, Halsey, Lannett, Mast Mm, Novel Labs Inc, Nuvo Pharm, Purepac Pharm, Sandoz, Vintage Pharms Llc, Vitarine, Shire, and Ferndale Labs, and is included in thirty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for dextroamphetamine sulfate. Seventeen suppliers are listed for this compound.

Drug Prices for DEXTROAMPHETAMINE SULFATE

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Recent Clinical Trials for DEXTROAMPHETAMINE SULFATE

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

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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
Specgx Llc DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 076353-001 May 6, 2003 AB RX No No   Start Trial   Start Trial   Start Trial
Avanthi Inc DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET;ORAL 203548-001 Nov 23, 2015 AA RX No No   Start Trial   Start Trial   Start Trial
Nesher Pharms DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 209111-002 Jun 27, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Lannett DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET;ORAL 085652-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Novel Labs Inc DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET;ORAL 204330-001 Mar 16, 2016 AA RX No No   Start Trial   Start Trial   Start Trial
>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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