Dextromethorphan hydrobromide; guaifenesin - Generic Drug Details
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What are the generic drug sources for dextromethorphan hydrobromide; guaifenesin and what is the scope of patent protection?
Dextromethorphan hydrobromide; guaifenesin
is the generic ingredient in two branded drugs marketed by Actavis Labs Fl, Amneal Pharms, Aurobindo Pharma, Dr Reddys, Perrigo R And D, Sun Pharm, and Rb Hlth, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.Sixty-three suppliers are listed for this compound.
Summary for dextromethorphan hydrobromide; guaifenesin
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 7 |
| NDAs: | 7 |
| Finished Product Suppliers / Packagers: | 63 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for dextromethorphan hydrobromide; guaifenesin |
| DailyMed Link: | dextromethorphan hydrobromide; guaifenesin at DailyMed |
Pharmacology for dextromethorphan hydrobromide; guaifenesin
| Drug Class | Expectorant Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist |
| Mechanism of Action | Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists |
| Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions |
Anatomical Therapeutic Chemical (ATC) Classes for dextromethorphan hydrobromide; guaifenesin
Paragraph IV (Patent) Challenges for DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| MUCINEX DM | Extended-release Tablets | dextromethorphan hydrobromide; guaifenesin | 600 mg/30 mg and 1200 mg/60 mg | 021620 | 1 | 2008-12-17 |
US Patents and Regulatory Information for dextromethorphan hydrobromide; guaifenesin
| 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 DM | dextromethorphan hydrobromide; guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021620-002 | Apr 29, 2004 | OTC | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rb Hlth | MUCINEX DM | dextromethorphan hydrobromide; guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021620-001 | Apr 29, 2004 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Dr Reddys | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | dextromethorphan hydrobromide; guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 217340-001 | Aug 1, 2023 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Actavis Labs Fl | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | dextromethorphan hydrobromide; guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 091070-001 | Aug 31, 2015 | OTC | 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 dextromethorphan hydrobromide; guaifenesin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Rb Hlth | MUCINEX DM | dextromethorphan hydrobromide; guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021620-001 | Apr 29, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Rb Hlth | MUCINEX DM | dextromethorphan hydrobromide; guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021620-002 | Apr 29, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Rb Hlth | MUCINEX DM | dextromethorphan hydrobromide; guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021620-001 | Apr 29, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Rb Hlth | MUCINEX DM | dextromethorphan hydrobromide; guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021620-002 | Apr 29, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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