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Last Updated: October 20, 2020

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Amphetamine - Generic Drug Details

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

Amphetamine is the generic ingredient in twenty-six branded drugs marketed by Neos Theraps Inc, Tris Pharma Inc, Neos Theraps, Teva, Takeda Pharms Usa, Actavis Elizabeth, Ani Pharms Inc, Elite Labs Inc, Impax Labs, Mylan, Nesher Pharms, Par Pharm Inc, Rhodes Pharms, Specgx Llc, Sun Pharm Industries, Barr Labs Inc, Teva Womens, Alvogen, Aurolife Pharma Llc, Barr, Bionpharma Inc, Epic Pharma Llc, Nuvo Pharm, Sandoz, Teva Pharms, Ucb Inc, Arbor Pharms Llc, Amneal Pharms, Cerovene Inc, Granules Pharms, Havix, Lannett, Mayne Pharma, Prinston Inc, and Riconpharma Llc, and is included in forty-eight NDAs. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amphetamine has twenty-three patent family members in fourteen countries.

There are fifty-five drug master file entries for amphetamine. Three suppliers are 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
University of California, Los AngelesEarly Phase 1
Weill Medical College of Cornell UniversityEarly Phase 1
Lindner Center of HOPEPhase 2

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Pharmacology for amphetamine
Paragraph IV (Patent) Challenges for AMPHETAMINE
Tradename Dosage Ingredient NDA Submissiondate
ADZENYS XR-ODT TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL amphetamine 204326 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
Takeda Pharms Usa MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-003 Jun 20, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Prinston Inc AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 211861-001 Mar 11, 2020 AA RX No No   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-002 Jun 20, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Nesher Pharms DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 210080-005 Jul 17, 2019 DISCN 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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