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Last Updated: September 19, 2020

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DEXEDRINE Drug Profile

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When do Dexedrine patents expire, and what generic alternatives are available?

Dexedrine is a drug marketed by Impax Labs Inc and Glaxosmithkline and is included in three NDAs.

The generic ingredient in DEXEDRINE is dextroamphetamine sulfate. There are eighteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the dextroamphetamine sulfate profile page.

Drug patent expirations by year for DEXEDRINE
Drug Prices for DEXEDRINE

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Recent Clinical Trials for DEXEDRINE

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

SponsorPhase
JPM van Stralen Medicine ProfessionalPhase 4
ShirePhase 4
Brain & Behavior Research FoundationPhase 1/Phase 2

See all DEXEDRINE clinical trials

Pharmacology for DEXEDRINE

US Patents and Regulatory Information for DEXEDRINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Impax Labs Inc DEXEDRINE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 017078-001 Approved Prior to Jan 1, 1982 AB RX Yes No   Start Trial   Start Trial   Start Trial
Glaxosmithkline DEXEDRINE dextroamphetamine sulfate ELIXIR;ORAL 083902-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Impax Labs Inc DEXEDRINE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 017078-002 Approved Prior to Jan 1, 1982 AB RX Yes No   Start Trial   Start Trial   Start Trial
Impax Labs Inc DEXEDRINE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 017078-003 Approved Prior to Jan 1, 1982 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline DEXEDRINE dextroamphetamine sulfate TABLET;ORAL 084935-001 Approved Prior to Jan 1, 1982 DISCN 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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Boehringer Ingelheim
Express Scripts
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Johnson and Johnson
Harvard Business School

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