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Last Updated: November 2, 2024

AMPHETAMINE Drug Patent Profile


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Which patents cover Amphetamine, and what generic alternatives are available?

Amphetamine is a drug marketed by Actavis Labs Fl Inc, Alkem Labs Ltd, Amneal Pharms, Aurolife Pharma Llc, Bionpharma, Cerovene Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Glenmark Pharms Ltd, Granules, Lannett, Novast Labs, Prinston Inc, Rhodes Pharms, Senores Pharms, Specgx Llc, and Sun Pharm Inds Inc. and is included in seventeen NDAs.

The generic ingredient in AMPHETAMINE is amphetamine sulfate. There are fifty-five drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Amphetamine

A generic version of AMPHETAMINE was approved as amphetamine sulfate by AMNEAL PHARMS on September 26th, 2018.

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Drug patent expirations by year for AMPHETAMINE
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 ZurichPhase 1
Stephen Robert MarderPhase 2
Virginia Commonwealth UniversityPhase 2

See all AMPHETAMINE clinical trials

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
Rhodes Pharms AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 213852-002 Sep 7, 2021 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novast Labs AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 213763-002 Aug 24, 2020 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Senores Pharms AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 212901-001 May 22, 2020 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Prinston Inc AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 211861-001 Mar 11, 2020 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actavis Labs Fl Inc AMPHETAMINE amphetamine TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 209253-001 Jun 22, 2023 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Sa AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 213898-002 Jul 14, 2020 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Granules AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 212619-002 Aug 5, 2019 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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