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

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Last Updated: December 5, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021620

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NDA 021620 describes MUCINEX DM, which is a drug marketed by Rb Hlth and is included in one NDA. It is available from twelve suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MUCINEX DM profile page.

The generic ingredient in MUCINEX DM is dextromethorphan hydrobromide; guaifenesin. There are twenty-three drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.
Summary for 021620
Tradename:MUCINEX DM
Applicant:Rb Hlth
Ingredient:dextromethorphan hydrobromide; guaifenesin
Patents:3
Suppliers and Packaging for NDA: 021620
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620 NDA walgreens 0363-0076 0363-0076-14 1 BLISTER PACK in 1 CARTON (0363-0076-14) > 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
MUCINEX DM dextromethorphan hydrobromide; guaifenesin TABLET, EXTENDED RELEASE;ORAL 021620 NDA walgreens 0363-0076 0363-0076-28 2 BLISTER PACK in 1 CARTON (0363-0076-28) > 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 021620
Tradename Dosage Ingredient NDA Submissiondate
MUCINEX DM TABLET, EXTENDED RELEASE;ORAL dextromethorphan hydrobromide; guaifenesin 021620 2008-12-17

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG;1.2GM
Approval Date:Apr 29, 2004TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 28, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Apr 28, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:EXPECTORANT AND COUGH SUPPRESSANT
Patent:  Start TrialPatent Expiration:Apr 28, 2020Product Flag?YSubstance Flag?Delist Request?

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