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Details for Generic Name: epinephrine

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Epinephrine is the generic ingredient in thirty-one branded drugs marketed by Sterling, Armstrong Pharms, Wyeth Cons, Forest Labs, Mylan Speclt, Amedra Pharms, Sanofi Aventis Us, 3M, Astrazeneca, Dentsply Pharm, Deproco, Septodont Inc, Par Sterile Products, Belcher Pharms Llc, Carlisle, Eastman Kodak, Graham Chem, Hikma Maple , Hospira, Abbott, Bel Mar, Dell Labs, Intl Medication, Watson Labs, Pharmaton, Septodont, Fresenius Kabi Usa, Vyteris, Iomed, and Empi, and is included in fifty-one NDAs. There are twenty-four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for epinephrine. Eleven suppliers are listed for this compound.

Summary for Generic Name: epinephrine

Drug Master File Entries: see list14
Suppliers: see list11
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: epinephrine

Clinical Trials for: epinephrine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION006488-005Approved Prior to Jan 1, 1982RXYes<disabled><disabled>
Sanofi Aventis Us
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS201739-002Aug 10, 2012RXYes7,749,194<disabled>Y<disabled>
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION084732-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION078772-002May 12, 2008RXNo<disabled><disabled>
Sanofi Aventis Us
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS201739-002Aug 10, 2012RXYes8,920,377<disabled>Y<disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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