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Last Updated: November 17, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205580

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NDA 205580 describes BELRAPZO, which is a drug marketed by Eagle Pharms and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the BELRAPZO profile page.

The generic ingredient in BELRAPZO is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.
Summary for 205580
Tradename:BELRAPZO
Applicant:Eagle Pharms
Ingredient:bendamustine hydrochloride
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 205580
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 205580
Suppliers and Packaging for NDA: 205580
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BELRAPZO bendamustine hydrochloride SOLUTION;IV (INFUSION) 205580 NDA Eagle Pharmaceuticals, Inc 42367-520 42367-520-25 1 VIAL, MULTI-DOSE in 1 CARTON (42367-520-25) > 1 INJECTION in 1 VIAL, MULTI-DOSE
BELRAPZO bendamustine hydrochloride SOLUTION;IV (INFUSION) 205580 NDA Eagle Pharmaceuticals, Inc 42367-521 42367-521-25 1 VIAL, MULTI-DOSE in 1 CARTON (42367-521-25) > 1 INJECTION in 1 VIAL, MULTI-DOSE
Paragraph IV (Patent) Challenges for 205580
Tradename Dosage Ingredient NDA Submissiondate
BELRAPZO SOLUTION;IV (INFUSION) bendamustine hydrochloride 205580 2018-07-17

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength100MG/4ML (25MG/ML)
Approval Date:May 15, 2018TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jan 28, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Aug 11, 2031Product Flag?YSubstance Flag?Delist Request?
Patented Use:FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
Patent:  Start TrialPatent Expiration:Aug 11, 2031Product Flag?YSubstance Flag?Delist Request?
Patented Use:FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

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