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Last Updated: November 29, 2020

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AMPHETAMINE SULFATE Drug Profile

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When do Amphetamine Sulfate patents expire, and when can generic versions of Amphetamine Sulfate launch?

Amphetamine Sulfate is a drug marketed by Amneal Pharms, Aurolife Pharma Llc, Bionpharma Inc, Cerovene Inc, Granules Pharms, Havix, Lannett, Mayne Pharma, Novast Labs, and Prinston Inc. and is included in ten NDAs.

The generic ingredient in AMPHETAMINE SULFATE is amphetamine sulfate. There are fifty-five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.

US ANDA Litigation and Generic Entry Outlook for Amphetamine Sulfate

A generic version of AMPHETAMINE SULFATE was approved as amphetamine sulfate by AMNEAL PHARMS on September 26th, 2018.

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Drug patent expirations by year for AMPHETAMINE SULFATE
Drug Prices for AMPHETAMINE SULFATE

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Recent Clinical Trials for AMPHETAMINE SULFATE

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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
Amneal Pharms AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 211139-001 Sep 26, 2018 AA RX No No   Start Trial   Start Trial   Start Trial
Novast Labs AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 213763-002 Aug 24, 2020 AA RX No No   Start Trial   Start Trial   Start Trial
Cerovene Inc AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 212582-001 Feb 4, 2020 AA RX No No   Start Trial   Start Trial   Start Trial
Aurolife Pharma Llc AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 211639-002 Apr 17, 2019 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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Serving leading biopharmaceutical companies globally:

Medtronic
Express Scripts
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McKesson

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