DrugPatentWatch Database Preview
AMPHETAMINE SULFATE Drug Profile
» See Plans and Pricing
When do Amphetamine Sulfate patents expire, and when can generic versions of Amphetamine Sulfate launch?
Amphetamine Sulfate is a drug marketed by Amneal Pharms, Aurolife Pharma Llc, Bionpharma Inc, Cerovene Inc, Granules Pharms, Havix, Lannett, Mayne Pharma, Novast Labs, and Prinston Inc. and is included in ten NDAs.
The generic ingredient in AMPHETAMINE SULFATE is amphetamine sulfate. There are fifty-five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.
US ANDA Litigation and Generic Entry Outlook for Amphetamine Sulfate
A generic version of AMPHETAMINE SULFATE was approved as amphetamine sulfate by AMNEAL PHARMS on September 26th, 2018.
Summary for AMPHETAMINE SULFATE
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 10 |
| Suppliers / Packagers: | 9 |
| Bulk Api Vendors: | 15 |
| Clinical Trials: | 6 |
| Patent Applications: | 754 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for AMPHETAMINE SULFATE |
| DailyMed Link: | AMPHETAMINE SULFATE at DailyMed |
Recent Clinical Trials for AMPHETAMINE SULFATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Vallon Pharmaceuticals, Inc. | Phase 1 |
| Arbor Pharmaceuticals, Inc. | Phase 3 |
| Sarah Morrow | Phase 2/Phase 3 |
Pharmacology for AMPHETAMINE SULFATE
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
US Patents and Regulatory Information for AMPHETAMINE SULFATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms | AMPHETAMINE SULFATE | amphetamine sulfate | TABLET;ORAL | 211139-001 | Sep 26, 2018 | AA | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Novast Labs | AMPHETAMINE SULFATE | amphetamine sulfate | TABLET;ORAL | 213763-002 | Aug 24, 2020 | AA | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Cerovene Inc | AMPHETAMINE SULFATE | amphetamine sulfate | TABLET;ORAL | 212582-001 | Feb 4, 2020 | AA | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Aurolife Pharma Llc | AMPHETAMINE SULFATE | amphetamine sulfate | TABLET;ORAL | 211639-002 | Apr 17, 2019 | AA | 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 |
