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Last Updated: March 28, 2024

AMPHETAMINE SULFATE - Generic Drug Details


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What are the generic sources for amphetamine sulfate and what is the scope of freedom to operate?

Amphetamine sulfate is the generic ingredient in three branded drugs marketed by Azurity, Alkem Labs Ltd, Amneal Pharms, Aurolife Pharma Llc, Bionpharma, Cerovene Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Glenmark Pharms Ltd, Granules, Lannett, Novast Labs, Prinston Inc, Rhodes Pharms, Rise Pharma, Specgx Llc, Sun Pharm Inds Inc, and Arbor Pharms Llc, and is included in eighteen NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for amphetamine sulfate. Fourteen suppliers are listed for this compound.

Drug Prices for AMPHETAMINE SULFATE

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Recent Clinical Trials for AMPHETAMINE SULFATE

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

SponsorPhase
Vallon Pharmaceuticals, Inc.Phase 1
Arbor Pharmaceuticals, Inc.Phase 3
Sarah MorrowPhase 2/Phase 3

See all AMPHETAMINE SULFATE clinical trials

Pharmacology for AMPHETAMINE SULFATE

US Patents and Regulatory Information for AMPHETAMINE SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glenmark Pharms Ltd AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 212186-001 Jan 27, 2021 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Sa AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 213898-001 Jul 14, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Epic Pharma Llc AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 213980-001 Oct 27, 2020 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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