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Last Updated: March 28, 2024

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, Actavis Labs Fl Inc, Teva, Takeda Pharms Usa, Actavis Elizabeth, Ani Pharms, Ascent Pharms Inc, Aurolife Pharma Llc, Elite Labs Inc, Granules, Impax Labs, Lannett Co Inc, Nesher Pharms, Par Pharm Inc, Rhodes Pharms, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva Pharms Usa, Barr Labs Inc, Teva Womens, Accord Hlthcare, Alkem Labs Ltd, Alvogen, Barr, Cediprof Inc, Epic Pharma Llc, Mylan, Nuvo Pharm, Sandoz, Teva Pharms, Uspharma Windlas, Zydus Pharms, Ucb Inc, Azurity, Amneal Pharms, Bionpharma, Cerovene Inc, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Lannett, Novast Labs, Prinston Inc, Rise Pharma, Arbor Pharms Llc, and Tris Pharma Inc, and is included in sixty-nine NDAs. There are nineteen 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Stephen Robert MarderPhase 2
Virginia Commonwealth UniversityPhase 2
Boston Children's HospitalPhase 1

See all AMPHETAMINE clinical trials

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
Tris Pharma Inc DYANAVEL XR amphetamine; amphetamine aspartate/dextroamphetamine sulfate SUSPENSION, EXTENDED RELEASE;ORAL 208147-001 Oct 19, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Lannett Co Inc DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 214403-006 Nov 26, 2021 AB1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Elite Labs Inc DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 211352-004 Dec 7, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Labs Fl Inc AMPHETAMINE amphetamine TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 209253-003 Jun 22, 2023 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
World Intellectual Property Organization (WIPO) 2013003622 ⤷  Try a Trial
European Patent Office 2726066 FORMES POSOLOGIQUES POUR ADMINISTRATION ORALE ET MÉTHODES DE TRAITEMENT LES UTILISANT (DOSAGE FORMS FOR ORAL ADMINISTRATION AND METHODS OF TREATMENT USING THE SAME) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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