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, Ingenus Pharms Llc, Lannett, 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 two drug master file entries for this compound. Twelve 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
Recent Clinical Trials for AMPHETAMINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Massachusetts Institute of Technology (MIT) | PHASE4 |
| Gagan Joshi | PHASE4 |
| Milton S. Hershey Medical Center | PHASE4 |
Pharmacology for AMPHETAMINE
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
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 | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Prinston Inc | AMPHETAMINE SULFATE | amphetamine sulfate | TABLET;ORAL | 211861-002 | Mar 11, 2020 | AA | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Senores Pharms | AMPHETAMINE SULFATE | amphetamine sulfate | TABLET;ORAL | 212901-001 | May 22, 2020 | AA | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Rhodes Pharms | AMPHETAMINE SULFATE | amphetamine sulfate | TABLET;ORAL | 213852-001 | Sep 7, 2021 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Actavis Labs Fl Inc | AMPHETAMINE | amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 209253-001 | Jun 22, 2023 | AB | RX | 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 |
