Guaifenesin; hydrocodone bitartrate - Generic Drug Details
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What are the generic drug sources for guaifenesin; hydrocodone bitartrate and what is the scope of freedom to operate?
Guaifenesin; hydrocodone bitartrate
is the generic ingredient in four branded drugs marketed by Chartwell Rx, Sovereign Pharms, and Eci Pharms Llc, and is included in four NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.One supplier is listed for this compound.
Summary for guaifenesin; hydrocodone bitartrate
| US Patents: | 3 |
| Tradenames: | 4 |
| Applicants: | 3 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 1 |
| DailyMed Link: | guaifenesin; hydrocodone bitartrate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for guaifenesin; hydrocodone bitartrate
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for guaifenesin; hydrocodone bitartrate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Reckitt Benckiser LLC | Phase 1 |
Pharmacology for guaifenesin; hydrocodone bitartrate
| Drug Class | Expectorant Opioid Agonist |
| Mechanism of Action | Opioid Agonists |
| Physiological Effect | Decreased Respiratory Secretion Viscosity Increased Respiratory Secretions |
Anatomical Therapeutic Chemical (ATC) Classes for guaifenesin; hydrocodone bitartrate
US Patents and Regulatory Information for guaifenesin; hydrocodone bitartrate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sovereign Pharms | OBREDON | guaifenesin; hydrocodone bitartrate | SOLUTION;ORAL | 205474-001 | Nov 14, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Chartwell Rx | HYCOFENIX | guaifenesin; hydrocodone bitartrate; pseudoephedrine hydrochloride | SOLUTION;ORAL | 022279-001 | May 14, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sovereign Pharms | OBREDON | guaifenesin; hydrocodone bitartrate | SOLUTION;ORAL | 205474-001 | Nov 14, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Chartwell Rx | FLOWTUSS | guaifenesin; hydrocodone bitartrate | SOLUTION;ORAL | 022424-001 | May 14, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Eci Pharms Llc | XTRELUS | guaifenesin; hydrocodone bitartrate | TABLET;ORAL | 208085-001 | Apr 25, 2018 | DISCN | Yes | 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 |
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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.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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