Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Chinese Patent Office
Julphar
UBS
Fuji
Citi
QuintilesIMS
Cipla
Farmers Insurance

Generated: July 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021585

« Back to Dashboard

NDA 021585 describes MUCINEX D, which is a drug marketed by Reckitt Benckiser and is included in two NDAs. It is available from eight suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MUCINEX D profile page.

The generic ingredient in MUCINEX D is dextromethorphan hydrobromide; guaifenesin. There are twenty-three drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.
Summary for 021585
Tradename:MUCINEX D
Applicant:Reckitt Benckiser
Ingredient:guaifenesin; pseudoephedrine hydrochloride
Patents:3
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021585
Generic Entry Date for 021585*:
Constraining patent/regulatory exclusivity:
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.

Pharmacology for NDA: 021585
Mechanism of ActionAdrenergic alpha-Agonists
Suppliers and Packaging for NDA: 021585
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585 NDA WALGREEN COMPANY 0363-0077 N 0363-0077-18
MUCINEX D guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021585 NDA WALGREEN COMPANY 0363-0077 N 0363-0077-36

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG;60MG
Approval Date:Jun 22, 2004TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Apr 28, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Apr 28, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:EXPECTORANT AND NASAL DECONGESTANT
Patent:➤ Sign UpPatent Expiration:Apr 28, 2020Product Flag?YSubstance Flag?Delist Request?

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
Deloitte
US Department of Justice
Mallinckrodt
Federal Trade Commission
Fuji
Johnson and Johnson
Argus Health

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. thinkBiotech performs no independent verifification 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.