GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug 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, Granules, L Perrigo Co, Sun Pharm Inds Inc, and Rb Hlth, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.Thirty suppliers are listed for this compound.
Summary for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 7 |
NDAs: | 7 |
Finished Product Suppliers / Packagers: | 30 |
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 |
Reckitt Benckiser Inc. | Phase 4 |
See all GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials
Pharmacology for GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Class | Expectorant alpha-Adrenergic Agonist |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-002 | Jun 22, 2004 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sun Pharm Inds Inc | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212542-001 | Apr 28, 2020 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Actavis Labs Fl | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 091071-001 | May 27, 2015 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sun Pharm Inds Inc | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212542-002 | Apr 28, 2020 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Granules | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 216082-002 | Aug 22, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-001 | Jun 22, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-001 | Jun 22, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-001 | Jun 22, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-002 | Jun 22, 2004 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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