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Last Updated: March 29, 2024

Epinephrine bitartrate - Generic Drug Details


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What are the generic sources for epinephrine bitartrate and what is the scope of patent protection?

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.

Recent Clinical Trials for epinephrine bitartrate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Novotech (Australia) Pty LimitedPhase 1
De Motu CordisPhase 1
Sunnybrook Health Sciences CentreN/A

See all epinephrine bitartrate clinical trials

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
Dentsply Pharm CITANEST FORTE DENTAL epinephrine bitartrate; prilocaine hydrochloride INJECTABLE;INJECTION 021383-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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
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
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
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
Astrazeneca DURANEST epinephrine bitartrate; etidocaine hydrochloride INJECTABLE;INJECTION 017751-007 Approved Prior to Jan 1, 1982 DISCN Yes 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

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