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Last Updated: August 3, 2020

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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 Arbor Pharms Llc, Amneal Pharms, Aurolife Pharma Llc, Bionpharma Inc, Cerovene Inc, Granules Pharms, Havix, Lannett, and Prinston Inc, and is included in ten NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are fifty-five drug master file entries for amphetamine sulfate. Nine suppliers are listed for this compound.

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
Cerovene Inc AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 212582-002 Feb 4, 2020 AA RX No No   Start Trial   Start Trial   Start Trial
Prinston Inc AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 211861-001 Mar 11, 2020 AA RX No No   Start Trial   Start Trial   Start Trial
Havix AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 212901-002 May 22, 2020 AA RX No No   Start Trial   Start Trial   Start Trial
Bionpharma Inc AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 212919-002 Nov 22, 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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