Epinephrine bitartrate - Generic Drug Details
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What are the generic drug sources for epinephrine bitartrate and what is the scope of freedom to operate?
Epinephrine bitartrate
is the generic ingredient in eight branded drugs marketed by Wyeth Cons, 3M, Astrazeneca, Dentsply Pharm, Deproco, and Septodont Inc, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.There are seven drug master file entries for epinephrine bitartrate.
Summary for epinephrine bitartrate
US Patents: | 0 |
Tradenames: | 8 |
Applicants: | 6 |
NDAs: | 9 |
Drug Master File Entries: | 7 |
Raw Ingredient (Bulk) Api Vendors: | 80 |
Clinical Trials: | 3 |
Patent Applications: | 1,338 |
Formulation / Manufacturing: | see details |
DailyMed Link: | epinephrine bitartrate at DailyMed |
Recent Clinical Trials for epinephrine bitartrate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
De Motu Cordis | Phase 1 |
Novotech (Australia) Pty Limited | Phase 1 |
Sunnybrook Health Sciences Centre | N/A |
Anatomical Therapeutic Chemical (ATC) Classes for epinephrine bitartrate
US Patents and Regulatory Information for epinephrine bitartrate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Wyeth Cons | BRONITIN MIST | epinephrine bitartrate | AEROSOL, METERED;INHALATION | 016126-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Deproco | LIGNOSPAN FORTE | epinephrine bitartrate; lidocaine hydrochloride | INJECTABLE;INJECTION | 088389-001 | Jan 22, 1985 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Dentsply Pharm | DURANEST | epinephrine bitartrate; etidocaine hydrochloride | INJECTABLE;INJECTION | 021384-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Astrazeneca | CITANEST FORTE | epinephrine bitartrate; prilocaine hydrochloride | INJECTABLE;INJECTION | 014763-008 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Septodont Inc | PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | epinephrine bitartrate; prilocaine hydrochloride | INJECTABLE;INJECTION | 078959-001 | Aug 30, 2011 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
3m | MEDIHALER-EPI | epinephrine bitartrate | AEROSOL, METERED;INHALATION | 010374-003 | Approved Prior to Jan 1, 1982 | DISCN | No | 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 |