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, Dr Reddys Labs Sa, Epic Pharma Llc, Glenmark Pharms Ltd, Granules, Lannett, Novast Labs, Prinston Inc, Rhodes Pharms, Sanaluz, 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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Summary for AMPHETAMINE
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Recent Clinical Trials for AMPHETAMINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Zurich | Phase 1 |
| Stephen Robert Marder | Phase 2 |
| Virginia Commonwealth University | Phase 2 |
Medical Subject Heading (MeSH) Categories 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sanaluz | AMPHETAMINE SULFATE | amphetamine sulfate | TABLET;ORAL | 212582-002 | Feb 4, 2020 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Prinston Inc | AMPHETAMINE SULFATE | amphetamine sulfate | TABLET;ORAL | 211861-002 | Mar 11, 2020 | AA | RX | 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 | |||
| Rhodes Pharms | AMPHETAMINE SULFATE | amphetamine sulfate | TABLET;ORAL | 213852-001 | Sep 7, 2021 | 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 | ||||
| Epic Pharma Llc | AMPHETAMINE SULFATE | amphetamine sulfate | TABLET;ORAL | 213980-002 | Oct 27, 2020 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lannett | AMPHETAMINE SULFATE | amphetamine sulfate | TABLET;ORAL | 083901-002 | Aug 31, 1984 | DISCN | Yes | 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 |
