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

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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021591

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NDA 021591 describes RIOMET, which is a drug marketed by Sun Pharm Inds Ltd and Sun Pharm and is included in two NDAs. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the RIOMET profile page.

The generic ingredient in RIOMET is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Ninety-eight suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
Summary for 021591
Tradename:RIOMET
Applicant:Sun Pharm Inds Ltd
Ingredient:metformin hydrochloride
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021591
Medical Subject Heading (MeSH) Categories for 021591
Suppliers and Packaging for NDA: 021591
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIOMET metformin hydrochloride SOLUTION;ORAL 021591 NDA Sun Pharmaceutical Industries, Inc. 10631-206 10631-206-01 118 mL in 1 BOTTLE (10631-206-01)
RIOMET metformin hydrochloride SOLUTION;ORAL 021591 NDA Sun Pharmaceutical Industries, Inc. 10631-206 10631-206-02 473 mL in 1 BOTTLE (10631-206-02)
Paragraph IV (Patent) Challenges for 021591
Tradename Dosage Ingredient NDA Submissiondate
RIOMET SOLUTION;ORAL metformin hydrochloride 021591 2018-02-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength500MG/5ML
Approval Date:Sep 11, 2003TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Aug 7, 2021Product Flag?YSubstance Flag?Delist Request?

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