DrugPatentWatch Database Preview
Guaifenesin; pseudoephedrine hydrochloride - Generic Drug Details
What are the generic drug sources for guaifenesin; pseudoephedrine hydrochloride and what is the scope of freedom to operate?
Guaifenesin; pseudoephedrine hydrochloride
is the generic ingredient in two branded drugs marketed by Actavis Labs Fl, Dr Reddys Labs Ltd, and Rb Hlth, and is included in three 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-three suppliers are listed for this compound.
Summary for guaifenesin; pseudoephedrine hydrochloride
| International Patents: | 39 |
| US Patents: | 3 |
| Tradenames: | 2 |
| Applicants: | 3 |
| NDAs: | 3 |
| Drug Master File Entries: | 20 |
| Suppliers / Packagers: | 23 |
| 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 |
| Glaxo Wellcome | Phase 2 |
See all guaifenesin; pseudoephedrine hydrochloride clinical trials
Recent Litigation for guaifenesin; pseudoephedrine hydrochloride
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| RECKITT BENCKISER LLC v. AMNEAL PHARMACEUTICALS LLC | 2015-03-26 |
| Reckitt Benckiser LLC v. Aurobindo Pharma Limited | 2014-09-17 |
| Adams Respiratory Therapeutics, Inc. v. Perrigo Company | 2007-10-02 |
See all guaifenesin; pseudoephedrine hydrochloride litigation
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 | 021585-002 | Jun 22, 2004 | OTC | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-002 | Jun 22, 2004 | OTC | Yes | Yes | 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 |
International Patents for guaifenesin; pseudoephedrine hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Israel | 164438 | Start Trial |
| World Intellectual Property Organization (WIPO) | 03088952 | Start Trial |
| South Africa | 200409171 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
