DEXTROAMPHETAMINE SULFATE - Generic Drug Details
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What are the generic drug sources for dextroamphetamine sulfate and what is the scope of patent protection?
Dextroamphetamine sulfate
is the generic ingredient in six branded drugs marketed by Impax Labs Inc, Able, Actavis Elizabeth, Dr Reddys Labs Sa, Nesher Pharms, Norvium Bioscience, Specgx Llc, Strides Pharma, Teva, Glaxosmithkline, Prasco, Tris Pharma Inc, Ani Pharms, Aurolife Pharma Llc, Avanthi Inc, Azurity, Barr, Epic Pharma Llc, Halsey, Lannett, Mast Mm, Novel Labs Inc, Nuvo Pharm, Purepac Pharm, Sandoz, Vitarine, Winder Labs Llc, Shire, and Ferndale Labs, and is included in forty NDAs. Additional information is available in the individual branded drug profile pages.There are eight drug master file entries for dextroamphetamine sulfate. Sixteen suppliers are listed for this compound.
Summary for DEXTROAMPHETAMINE SULFATE
US Patents: | 0 |
Tradenames: | 6 |
Applicants: | 29 |
NDAs: | 40 |
Drug Master File Entries: | 8 |
Finished Product Suppliers / Packagers: | 16 |
Raw Ingredient (Bulk) Api Vendors: | 22 |
Clinical Trials: | 8 |
Patent Applications: | 6,815 |
Drug Prices: | Drug price trends for DEXTROAMPHETAMINE SULFATE |
What excipients (inactive ingredients) are in DEXTROAMPHETAMINE SULFATE? | DEXTROAMPHETAMINE SULFATE excipients list |
DailyMed Link: | DEXTROAMPHETAMINE SULFATE at DailyMed |
Recent Clinical Trials for DEXTROAMPHETAMINE SULFATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Vallon Pharmaceuticals, Inc. | Phase 1 |
Medical University of Vienna | N/A |
Centre hospitalier de l'Université de Montréal (CHUM) | Phase 2 |
Pharmacology for DEXTROAMPHETAMINE SULFATE
Drug Class | Central Nervous System Stimulant |
Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for DEXTROAMPHETAMINE SULFATE
US Patents and Regulatory Information for DEXTROAMPHETAMINE SULFATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aurolife Pharma Llc | DEXTROAMPHETAMINE SULFATE | dextroamphetamine sulfate | TABLET;ORAL | 202893-002 | Jul 31, 2013 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Tris Pharma Inc | DEXTROAMPHETAMINE SULFATE | dextroamphetamine sulfate | TABLET;ORAL | 206095-002 | Aug 18, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Nesher Pharms | DEXTROAMPHETAMINE SULFATE | dextroamphetamine sulfate | TABLET;ORAL | 040367-001 | Oct 31, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Shire | DEXTROSTAT | dextroamphetamine sulfate | TABLET;ORAL | 084051-002 | Approved Prior to Jan 1, 1982 | 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 |
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