DEXEDRINE Drug Patent Profile
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When do Dexedrine patents expire, and what generic alternatives are available?
Dexedrine is a drug marketed by Impax Labs Inc and Glaxosmithkline and is included in three NDAs.
The generic ingredient in DEXEDRINE is dextroamphetamine sulfate. There are eighteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the dextroamphetamine sulfate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dexedrine
A generic version of DEXEDRINE was approved as dextroamphetamine sulfate by BARR on January 31st, 2001.
Summary for DEXEDRINE
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 17 |
Clinical Trials: | 16 |
Patent Applications: | 4,128 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for DEXEDRINE |
What excipients (inactive ingredients) are in DEXEDRINE? | DEXEDRINE excipients list |
DailyMed Link: | DEXEDRINE at DailyMed |
Recent Clinical Trials for DEXEDRINE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
JPM van Stralen Medicine Professional | Phase 4 |
Shire | Phase 4 |
Yale University | Phase 1/Phase 2 |
Pharmacology for DEXEDRINE
Drug Class | Central Nervous System Stimulant |
Physiological Effect | Central Nervous System Stimulation |
US Patents and Regulatory Information for DEXEDRINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Impax Labs Inc | DEXEDRINE | dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 017078-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Glaxosmithkline | DEXEDRINE | dextroamphetamine sulfate | ELIXIR;ORAL | 083902-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Impax Labs Inc | DEXEDRINE | dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 017078-002 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Impax Labs Inc | DEXEDRINE | dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 017078-003 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Glaxosmithkline | DEXEDRINE | dextroamphetamine sulfate | TABLET;ORAL | 084935-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |