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Last Updated: September 26, 2022

AMPHETAMINE - Generic Drug Details


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What are the generic sources for amphetamine and what is the scope of freedom to operate?

Amphetamine is the generic ingredient in thirty-one branded drugs marketed by Neos Theraps Inc, Neos Theraps, Teva, Rhodes Pharms, Takeda Pharms Usa, Ascent Pharms Inc, Lannett Co Inc, Actavis Elizabeth, Ani Pharms, Aurolife Pharma Llc, Elite Labs Inc, Impax Labs, Nesher Pharms, Par Pharm Inc, Specgx Llc, Sun Pharm Industries, Teva Pharms Usa, Barr Labs Inc, Teva Womens, Accord Hlthcare, Alvogen, Barr, Cediprof Inc, Epic Pharma Llc, Granules, Mylan, Nuvo Pharm, Sandoz, Teva Pharms, Uspharma Windlas, Zydus Pharms, Ucb Inc, Azurity, Alkem Labs Ltd, Amneal Pharms, Bionpharma Inc, Cerovene Inc, Glenmark Pharms Ltd, Lannett, Mayne Pharma, Novast Labs, Prinston Inc, Senores Pharms, Sun Pharm Inds Inc, Arbor Pharms Llc, and Tris Pharma Inc, and is included in sixty-four NDAs. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amphetamine has two patent family members in two countries.

There are fifty-five drug master file entries for amphetamine. One supplier is listed for this compound.

Drug Prices for AMPHETAMINE

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Drug Sales Revenue Trends for AMPHETAMINE

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Recent Clinical Trials for AMPHETAMINE

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SponsorPhase
University of Alabama at BirminghamPhase 4
University of California, San FranciscoPhase 2
University of California, Los AngelesEarly Phase 1

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Pharmacology for AMPHETAMINE
Paragraph IV (Patent) Challenges for AMPHETAMINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ADZENYS XR-ODT Extended-release Orally Disintegrating Tablets amphetamine 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg 204326 1 2016-05-10

US Patents and Regulatory Information for AMPHETAMINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Neos Theraps ADZENYS XR-ODT amphetamine TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 204326-001 Jan 27, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-004 Jun 20, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rhodes Pharms DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 213111-002 Jan 13, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Impax Labs DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 076852-006 Feb 16, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurolife Pharma Llc DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 202424-001 Nov 27, 2013 AB 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

International Patents for AMPHETAMINE

Country Patent Number Title Estimated Expiration
European Patent Office 2726066 FORMES POSOLOGIQUES POUR ADMINISTRATION ORALE ET M√ČTHODES DE TRAITEMENT LES UTILISANT (DOSAGE FORMS FOR ORAL ADMINISTRATION AND METHODS OF TREATMENT USING THE SAME) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2013003622 See Plans and Pricing
>Country >Patent Number >Title >Estimated 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.