Amphetamine - Generic Drug Details
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What are the generic drug sources for amphetamine and what is the scope of freedom to operate?
Amphetamine
is the generic ingredient in thirty-one branded drugs marketed by Neos Theraps Inc, Neos Theraps, Actavis Labs Fl Inc, Teva, Takeda Pharms Usa, Actavis Elizabeth, Ani Pharms, Ascent Pharms Inc, Aurolife Pharma Llc, Elite Labs Inc, Endo Operations, Granules, Impax Labs, Lannett Co Inc, Nesher Pharms, Rhodes Pharms, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva Pharms Usa, Barr Labs Inc, Teva Womens, Accord Hlthcare, Alkem Labs Ltd, Alvogen, Barr, Cediprof Inc, Epic Pharma Llc, Norvium Bioscience, Nuvo Pharm, Sandoz, Teva Pharms, Uspharma Windlas, Zydus Pharms, Ucb Inc, Azurity, Amneal Pharms, Bionpharma, Cerovene Inc, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Lannett, Novast Labs, Prinston Inc, Senores Pharms, and Tris Pharma Inc, and is included in sixty-nine NDAs. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.Amphetamine has two patent family members in two countries.
There are fifty-five drug master file entries for amphetamine. One supplier is listed for this compound.
Summary for amphetamine
International Patents: | 2 |
US Patents: | 21 |
Tradenames: | 31 |
Applicants: | 46 |
NDAs: | 69 |
Drug Master File Entries: | 55 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 38 |
Clinical Trials: | 167 |
Patent Applications: | 6,849 |
Drug Prices: | Drug price trends for amphetamine |
Drug Sales Revenues: | Drug sales revenues for amphetamine |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for amphetamine |
What excipients (inactive ingredients) are in amphetamine? | amphetamine excipients list |
DailyMed Link: | amphetamine at DailyMed |
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 |
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
International Patents for amphetamine
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2726066 | FORMES POSOLOGIQUES POUR ADMINISTRATION ORALE ET MÉTHODES DE TRAITEMENT LES UTILISANT (DOSAGE FORMS FOR ORAL ADMINISTRATION AND METHODS OF TREATMENT USING THE SAME) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2013003622 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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