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Last Updated: October 26, 2021

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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, Alkem Labs Ltd, Amneal Pharms, Aurolife Pharma Llc, Bionpharma Inc, Cerovene Inc, Epic Pharma Llc, Glenmark Pharms Ltd, Granules, Lannett, Mayne Pharma, Novast Labs, Prinston Inc, Rhodes Pharms, Senores Pharms, Specgx Llc, and Sun Pharm Inds Inc, and is included in eighteen 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. 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
Novast Labs AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 213763-001 Aug 24, 2020 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Cerovene Inc AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 212582-002 Feb 4, 2020 AA RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Senores Pharms AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 212901-001 May 22, 2020 AA RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Lannett AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 083901-002 Aug 31, 1984 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mayne Pharma AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 213898-002 Jul 14, 2020 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Glenmark Pharms Ltd AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 212186-002 Jan 27, 2021 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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:

Colorcon
Harvard Business School
Boehringer Ingelheim
AstraZeneca
Johnson and Johnson
Dow

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