Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 15, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205029

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NDA 205029 describes EPINEPHRINE, which is a drug marketed by Armstrong Pharms, Am Regent, Belcher Pharms Llc, and Teva Pharms Usa, and is included in four NDAs. It is available from five suppliers. There are three patents protecting this drug. Additional details are available on the EPINEPHRINE profile page.

The generic ingredient in EPINEPHRINE is epinephrine. There are twenty-one drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
Summary for 205029
Tradename:EPINEPHRINE
Applicant:Belcher Pharms Llc
Ingredient:epinephrine
Patents:3
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 205029
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPINEPHRINE epinephrine SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS 205029 NDA General Injectables and Vaccines, Inc. 52584-103 52584-103-01 1 AMPULE in 1 BAG (52584-103-01) > 1 mL in 1 AMPULE
EPINEPHRINE epinephrine SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS 205029 NDA BPI Labs, LLC 54288-103 54288-103-10 10 AMPULE in 1 BOX (54288-103-10) > 1 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUSStrengthEQ 1MG BASE/ML (EQ 1MG BASE/ML)
Approval Date:Jul 29, 2014TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Aug 14, 2034Product Flag?YSubstance Flag?Delist Request?
Patented Use:EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE 1), INCLUDING ANAPHYLAXIS; A METHOD OF TREATING ALLERGIC REACTION, ANAPHYLAXIS, ANAPHYLACTIC SHOCK, OR COMBINATION THEREOF BY AN INJECTION OF AT LEAST ONE DOSAGE OF THE INJECTABLE LIQUID PHARMACEUTICAL
Patent:  Start TrialPatent Expiration:Aug 14, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:INCREASING MEAN ARTERIAL BLOOD PRESSURE IN ADULT PATIENTS WITH HYPOTENSION ASSOCIATED WITH SEPTIC SHOCK
Patent:  Start TrialPatent Expiration:Aug 15, 2034Product Flag?YSubstance Flag?Delist Request?
Patented Use:EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS

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