MUCINEX DM Drug Patent Profile
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Which patents cover Mucinex Dm, and when can generic versions of Mucinex Dm launch?
Mucinex Dm is a drug marketed by Rb Hlth and is included in one NDA.
The generic ingredient in MUCINEX DM is dextromethorphan hydrobromide; guaifenesin. There are twenty-three drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.
Summary for MUCINEX DM
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 2 |
Clinical Trials: | 16 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for MUCINEX DM |
Drug Sales Revenues: | Drug sales revenues for MUCINEX DM |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MUCINEX DM |
What excipients (inactive ingredients) are in MUCINEX DM? | MUCINEX DM excipients list |
DailyMed Link: | MUCINEX DM at DailyMed |
Recent Clinical Trials for MUCINEX DM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Vitaccess Ltd | Phase 4 |
American Health Research | Phase 4 |
Massachusetts Eye and Ear Infirmary | N/A |
Pharmacology for MUCINEX DM
Drug Class | Expectorant Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist |
Mechanism of Action | Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists |
Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions |
Anatomical Therapeutic Chemical (ATC) Classes for MUCINEX DM
Paragraph IV (Patent) Challenges for MUCINEX DM
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
MUCINEX DM | Extended-release Tablets | dextromethorphan hydrobromide; guaifenesin | 600 mg/30 mg and 1200 mg/60 mg | 021620 | 1 | 2008-12-17 |
US Patents and Regulatory Information for MUCINEX DM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Rb Hlth | MUCINEX DM | dextromethorphan hydrobromide; guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021620-002 | Apr 29, 2004 | OTC | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Rb Hlth | MUCINEX DM | dextromethorphan hydrobromide; guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021620-001 | Apr 29, 2004 | OTC | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for MUCINEX DM
International Patents for MUCINEX DM
See the table below for patents covering MUCINEX DM around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | 200733952 | ⤷ Try a Trial | |
Israel | 190742 | ⤷ Try a Trial | |
South Africa | 200409171 | SUSTAINED RELEASE OF GUAIFENESIN COMBINATION DRUGS | ⤷ Try a Trial |
China | 1655766 | ⤷ Try a Trial | |
Canada | 2481739 | LIBERATION REGULIERE DE MEDICAMENTS COMBINES DE GUAIFENESIN (SUSTAINED RELEASE OF GUAIFENESIN COMBINATION DRUGS) | ⤷ Try a Trial |
Taiwan | I314866 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MUCINEX DM
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1539166 | SPC/GB13/070 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, E.G. Q; REGISTERED: UK EU/1/13/833 20130626 |
1539166 | 2013C/064 | Belgium | ⤷ Try a Trial | PRODUCT NAME: DEXTROMETHORPHANE OU UN SEL, PRCURSEUR DE DERIVE PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRURE DE DEXTROMETORPHANE ET EN PARTICULIER LE BROMHYDRURE DE DEXTROMETROPHANE MONHYDRATE ET QUINIDINE OU UN SEL,....; AUTHORISATION NUMBER AND DATE: EU/1/13/833 20130626 |
1539166 | CA 2013 00059 | Denmark | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624 |
1539166 | CR 2013 00059 | Denmark | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624 |
1539166 | 2013/055 | Ireland | ⤷ Try a Trial | PRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. QUINIDINE SULPHATE AND IN PARTICULAR QUINIDINE SULPHATE DIHYDRATE, PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/833 20130624 |
1539166 | 122013000090 | Germany | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION AUS: (A) DEXTROMETHORPHAN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ, Z.B. DEXTROMETHORPHAN-HYDROBROMID UND INSBESONDERE DEXTROMETHORPHAN-HYDROBROMID-MONOHYDRAT; UND (B) CHINIDIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, Z.B.CHINIDIN-SULFAT UND INSBESONDERE CHINIDIN-SULFAT-DIHYDRAT; REGISTRATION NO/DATE: EU/1/13/833 20130624 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |