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Last Updated: January 27, 2023

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 Inc, Cerovene Inc, Epic Pharma Llc, Glenmark Pharms Ltd, Granules, Lannett, Mayne Pharma, 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. Fifteen 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
Epic Pharma Llc AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 213980-002 Oct 27, 2020 AA RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Arbor Pharms Llc EVEKEO amphetamine sulfate TABLET;ORAL 200166-002 Aug 9, 2012 AA RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lannett AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 083901-002 Aug 31, 1984 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-003 Jan 30, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Rise Pharma AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 212901-001 May 22, 2020 AA RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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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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.