Last Updated: May 10, 2026

Details for New Drug Application (NDA): 217338


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NDA 217338 describes MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM, which is a drug marketed by Rb Hlth and is included in one NDA. There are three patents protecting this drug. Additional details are available on the MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM profile page.

The generic ingredient in MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM is dextromethorphan hydrobromide; guaifenesin; naproxen sodium. There are twenty-three drug master file entries for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin; naproxen sodium profile page.
Summary for 217338
Tradename:MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM
Applicant:Rb Hlth
Ingredient:dextromethorphan hydrobromide; guaifenesin; naproxen sodium
Patents:3
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217338
Generic Entry Date for 217338*:
⤷  Start Trial
Constraining patent/regulatory exclusivity:
⤷  Start Trial
Dosage:
TABLET, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG;600MG;110MG
Approval Date:Dec 22, 2025TE:RLD:Yes
Patent:⤷  Start TrialPatent Expiration:Oct 11, 2036Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Start TrialPatent Expiration:Oct 11, 2036Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Start TrialPatent Expiration:Oct 11, 2036Product Flag?YSubstance Flag?Delist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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