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Last Updated: September 26, 2021

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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, Rhodes Pharms, Takeda Pharms Usa, Actavis Elizabeth, Ani Pharms, Elite Labs Inc, Impax Labs, Mylan, Nesher Pharms, Par Pharm Inc, Specgx Llc, Sun Pharm Industries, Barr Labs Inc, Teva Womens, Alvogen, Ascent Pharms Inc, Aurolife Pharma Llc, Barr, Epic Pharma Llc, Nuvo Pharm, Sandoz, Teva Pharms, Uspharma, Ucb Inc, Arbor Pharms Llc, Alkem Labs Ltd, Amneal Pharms, Bionpharma Inc, Cerovene Inc, Glenmark Pharms Ltd, Granules, Havix, Lannett, Mayne Pharma, Novast Labs, Prinston Inc, and Sun Pharm Inds Inc, and is included in fifty-five 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 Alabama at BirminghamPhase 4
Rajesh NarendranEarly Phase 1
University of California, San FranciscoPhase 2

See all amphetamine clinical trials

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
Tris Pharma Inc DYANAVEL XR amphetamine SUSPENSION, EXTENDED RELEASE;ORAL 208147-001 Oct 19, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Actavis Elizabeth DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 206340-001 Feb 5, 2016 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Uspharma DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 210293-005 Apr 3, 2020 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Nesher Pharms DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 210080-006 Jul 17, 2019 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Teva DELCOBESE amphetamine adipate; amphetamine sulfate; dextroamphetamine adipate; dextroamphetamine sulfate TABLET;ORAL 083563-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 211876-002 Jun 24, 2020 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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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Serving leading biopharmaceutical companies globally:

McKesson
Moodys
Merck
Mallinckrodt
McKinsey
Medtronic

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