DrugPatentWatch Database Preview
Guaifenesin; pseudoephedrine hydrochloride - Generic Drug Details
» See Plans and Pricing
What are the generic sources for guaifenesin; pseudoephedrine hydrochloride and what is the scope of patent protection?
Guaifenesin; pseudoephedrine hydrochloride
is the generic ingredient in two branded drugs marketed by Actavis Labs Fl, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Sun Pharm Inds Inc, and Rb Hlth, and is included in five NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Guaifenesin; pseudoephedrine hydrochloride has thirty-nine patent family members in nineteen countries.
There are twenty drug master file entries for guaifenesin; pseudoephedrine hydrochloride. Twenty-seven suppliers are listed for this compound.
Summary for guaifenesin; pseudoephedrine hydrochloride
International Patents: | 39 |
US Patents: | 3 |
Tradenames: | 2 |
Applicants: | 5 |
NDAs: | 5 |
Drug Master File Entries: | 20 |
Suppliers / Packagers: | 27 |
Clinical Trials: | 4 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for guaifenesin; pseudoephedrine hydrochloride |
DailyMed Link: | guaifenesin; pseudoephedrine hydrochloride at DailyMed |
Recent Clinical Trials for guaifenesin; pseudoephedrine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Dr. Reddy's Laboratories Limited | Phase 1 |
Reckitt Benckiser LLC | Phase 4 |
Mantecorp Industria Quimica e Farmaceutica Ltd. | Phase 3 |
See all guaifenesin; pseudoephedrine hydrochloride clinical trials
Paragraph IV (Patent) Challenges for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
MUCINEX D | TABLET, EXTENDED RELEASE;ORAL | guaifenesin; pseudoephedrine hydrochloride | 021585 | 2008-12-29 |
US Patents and Regulatory Information for guaifenesin; pseudoephedrine hydrochloride
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 | Start Trial | Start Trial | Y | Start Trial | |||
Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-001 | Jun 22, 2004 | OTC | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-001 | Jun 22, 2004 | OTC | Yes | No | Start Trial | Start Trial | Y | Start 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 guaifenesin; pseudoephedrine hydrochloride
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 | Start Trial | Start Trial |
Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-001 | Jun 22, 2004 | Start Trial | Start Trial |
Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-001 | Jun 22, 2004 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for guaifenesin; pseudoephedrine hydrochloride
Country | Patent Number | Estimated Expiration |
---|---|---|
Hong Kong | 1052651 | Start Trial |
China | 1655766 | Start Trial |
Spain | 2301537 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |