MUCINEX D Drug Patent Profile
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When do Mucinex D patents expire, and when can generic versions of Mucinex D launch?
Mucinex D is a drug marketed by Rb Hlth and is included in two NDAs.
The generic ingredient in MUCINEX D is dextromethorphan hydrobromide; guaifenesin. There are twenty-three drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin profile page.
Summary for MUCINEX D
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 6 |
Clinical Trials: | 16 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for MUCINEX D |
Drug Sales Revenues: | Drug sales revenues for MUCINEX D |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MUCINEX D |
What excipients (inactive ingredients) are in MUCINEX D? | MUCINEX D excipients list |
DailyMed Link: | MUCINEX D at DailyMed |



Recent Clinical Trials for MUCINEX D
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 D
Drug Class | alpha-Adrenergic Agonist Expectorant |
Mechanism of Action | Adrenergic alpha-Agonists |
Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions |
Anatomical Therapeutic Chemical (ATC) Classes for MUCINEX D
Paragraph IV (Patent) Challenges for MUCINEX D
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
MUCINEX D | Extended-release Tablets | guaifenesin; pseudoephedrine hydrochloride | 600 mg/60 mg and 1200 mg/120 mg | 021585 | 1 | 2008-12-29 |
US Patents and Regulatory Information for MUCINEX D
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 D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-002 | Jun 22, 2004 | OTC | Yes | Yes | ⤷ 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 | ||||
Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-001 | Jun 22, 2004 | OTC | Yes | No | ⤷ 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 D
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-002 | Jun 22, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-002 | Jun 22, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-001 | Jun 22, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for MUCINEX D
See the table below for patents covering MUCINEX D around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | 200727919 | ⤷ Try a Trial | |
Israel | 152012 | GUAIFENESIN SUSTAINED RELEASE FORMULATION AND TABLETS | ⤷ Try a Trial |
Israel | 164438 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |