Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: November 17, 2019

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Amphetamine sulfate - Generic Drug Details

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What are the generic drug sources for amphetamine sulfate and what is the scope of patent protection?

Amphetamine sulfate is the generic ingredient in three branded drugs marketed by Arbor Pharms Llc, Amneal Pharms, Aurolife Pharma Llc, Granules Pharms, and Lannett, and is included in six 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. Five 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
Arbor Pharmaceuticals, Inc.Phase 3
Sarah MorrowPhase 2/Phase 3
Arbor Pharmaceuticals, Inc.Phase 4

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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
Arbor Pharms Llc EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-003 Jan 30, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Arbor Pharms Llc EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-001 Jan 30, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Amneal Pharms AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 211139-002 Sep 26, 2018 AA RX No No   Start Trial   Start Trial   Start Trial
Arbor Pharms Llc EVEKEO amphetamine sulfate TABLET;ORAL 200166-001 Aug 9, 2012 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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Harvard Business School
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Dow

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 verifification 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.