Amphetamine sulfate - Generic Drug Details
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What are the generic drug sources for amphetamine sulfate and what is the scope of freedom to operate?
Amphetamine sulfate
is the generic ingredient in three branded drugs marketed by Azurity, 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 eighteen NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are twenty drug master file entries for amphetamine sulfate. Thirteen suppliers are listed for this compound.
Summary for amphetamine sulfate
US Patents: | 4 |
Tradenames: | 3 |
Applicants: | 17 |
NDAs: | 18 |
Drug Master File Entries: | 20 |
Finished Product Suppliers / Packagers: | 13 |
Raw Ingredient (Bulk) Api Vendors: | 24 |
Clinical Trials: | 8 |
Patent Applications: | 1,536 |
Drug Prices: | Drug price trends for amphetamine sulfate |
What excipients (inactive ingredients) are in amphetamine sulfate? | amphetamine sulfate excipients list |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Azurity | EVEKEO ODT | amphetamine sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 209905-002 | Jan 30, 2019 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Rhodes Pharms | AMPHETAMINE SULFATE | amphetamine sulfate | TABLET;ORAL | 213852-002 | Sep 7, 2021 | 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 | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for amphetamine sulfate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Azurity | EVEKEO ODT | amphetamine sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 209905-004 | Jan 30, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Azurity | EVEKEO ODT | amphetamine sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 209905-003 | Jan 30, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Azurity | EVEKEO ODT | amphetamine sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 209905-005 | Apr 16, 2021 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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