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Last Updated: June 21, 2024

AMPHETAMINE SULFATE - Generic Drug Details


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What are the generic drug 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, Senores Pharms, Specgx Llc, and Sun Pharm Inds Inc, and is included in eighteen NDAs. There are four 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

See drug prices for AMPHETAMINE SULFATE

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
Amneal Pharms AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 211139-001 Sep 26, 2018 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-002 Jan 30, 2019 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novast Labs AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 213763-002 Aug 24, 2020 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-004 Jan 30, 2019 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Granules AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 212619-002 Aug 5, 2019 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for AMPHETAMINE SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-001 Jan 30, 2019 ⤷  Sign Up ⤷  Sign Up
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-005 Apr 16, 2021 ⤷  Sign Up ⤷  Sign Up
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-003 Jan 30, 2019 ⤷  Sign Up ⤷  Sign Up
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-002 Jan 30, 2019 ⤷  Sign Up ⤷  Sign Up
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-004 Jan 30, 2019 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.