Guaifenesin; pseudoephedrine hydrochloride - Generic Drug Details
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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, L Perrigo Co, Sun Pharm Inds Inc, and Rb Hlth, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.Thirty-one suppliers are listed for this compound.
Summary for guaifenesin; pseudoephedrine hydrochloride
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 6 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 31 |
| 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 Inc. | Phase 4 |
| Reckitt Benckiser LLC | Phase 4 |
See all guaifenesin; pseudoephedrine hydrochloride clinical trials
Pharmacology for guaifenesin; pseudoephedrine hydrochloride
| 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 guaifenesin; pseudoephedrine hydrochloride
Paragraph IV (Patent) Challenges for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
| 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 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma Ltd | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 213203-002 | Mar 25, 2020 | OTC | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Sun Pharm Inds Inc | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212542-002 | Apr 28, 2020 | OTC | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| L Perrigo Co | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 214407-002 | Feb 1, 2022 | OTC | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-001 | Jun 22, 2004 | OTC | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Actavis Labs Fl | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 091071-002 | May 27, 2015 | OTC | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >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 | See Plans and Pricing | See Plans and Pricing |
| Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-002 | Jun 22, 2004 | See Plans and Pricing | See Plans and Pricing |
| Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-001 | Jun 22, 2004 | See Plans and Pricing | See Plans and Pricing |
| Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-001 | Jun 22, 2004 | See Plans and Pricing | See Plans and Pricing |
| Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-001 | Jun 22, 2004 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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