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 Glaxosmithkline and Impax Labs Inc 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.
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Questions you can ask:
- What is the 5 year forecast for DEXEDRINE?
- What are the global sales for DEXEDRINE?
- What is Average Wholesale Price for DEXEDRINE?
Summary for DEXEDRINE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 17 |
| Clinical Trials: | 16 |
| Patent Applications: | 4,173 |
| 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline | DEXEDRINE | dextroamphetamine sulfate | ELIXIR;ORAL | 083902-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Impax Labs Inc | DEXEDRINE SPANSULE | dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 017078-002 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Glaxosmithkline | DEXEDRINE | dextroamphetamine sulfate | TABLET;ORAL | 084935-001 | 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 |
