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Guaifenesin - Generic Drug Details
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What are the generic sources for guaifenesin and what is the scope of freedom to operate?
Guaifenesin
is the generic ingredient in eight branded drugs marketed by Actavis Labs Fl, Amneal Pharms, Aurobindo Pharma Ltd, Granules, Guardian Drug, Ohm Labs Inc, Perrigo R And D, Rb Hlth, Bkk Pharms, Sovereign Pharms, Eci Pharms Llc, Dr Reddys Labs Ltd, and Sun Pharm Inds Inc, and is included in seventeen NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Guaifenesin has thirty-nine patent family members in nineteen countries.
There are twenty drug master file entries for guaifenesin. Forty-nine suppliers are listed for this compound.
Summary for guaifenesin
International Patents: | 39 |
US Patents: | 6 |
Tradenames: | 8 |
Applicants: | 13 |
NDAs: | 17 |
Drug Master File Entries: | 20 |
Suppliers / Packagers: | 49 |
Bulk Api Vendors: | 96 |
Clinical Trials: | 29 |
Patent Applications: | 6,339 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for guaifenesin |
Drug Sales Revenues: | Drug sales revenues for guaifenesin |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for guaifenesin |
What excipients (inactive ingredients) are in guaifenesin? | guaifenesin excipients list |
DailyMed Link: | guaifenesin at DailyMed |
Recent Clinical Trials for guaifenesin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Johnson & Johnson Consumer and Personal Products Worldwide | N/A |
Hoffmann-La Roche | N/A |
Ache Laboratorios Farmaceuticos S.A. | Phase 3 |
Medical Subject Heading (MeSH) Categories for guaifenesin
Paragraph IV (Patent) Challenges for GUAIFENESIN
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
MUCINEX | TABLET, EXTENDED RELEASE;ORAL | guaifenesin | 021282 | 2006-06-09 |
US Patents and Regulatory Information for guaifenesin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Granules | GUAIFENESIN | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 213420-002 | May 8, 2020 | OTC | No | No | Start Trial | Start Trial | Start Trial | ||||
Rb Hlth | MUCINEX D | guaifenesin; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021585-001 | Jun 22, 2004 | OTC | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Sovereign Pharms | OBREDON | guaifenesin; hydrocodone bitartrate | SOLUTION;ORAL | 205474-001 | Nov 14, 2014 | DISCN | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
Perrigo R And D | GUAIFENESIN | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 078912-002 | Nov 5, 2020 | OTC | No | No | Start Trial | Start Trial | Start Trial | ||||
Amneal Pharms | GUAIFENESIN | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 207342-002 | Jul 11, 2018 | OTC | No | No | Start Trial | Start Trial | Start Trial | ||||
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Rb Hlth | MUCINEX | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021282-002 | Dec 18, 2002 | Start Trial | Start Trial |
Rb Hlth | MUCINEX | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021282-001 | Jul 12, 2002 | Start Trial | Start Trial |
Rb Hlth | MUCINEX | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021282-001 | Jul 12, 2002 | Start Trial | Start Trial |
Rb Hlth | MUCINEX | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021282-002 | Dec 18, 2002 | Start Trial | Start Trial |
Rb Hlth | MUCINEX | guaifenesin | TABLET, EXTENDED RELEASE;ORAL | 021282-001 | Jul 12, 2002 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for guaifenesin
Country | Patent Number | Estimated Expiration |
---|---|---|
Canada | 2405031 | Start Trial |
Portugal | 1276467 | Start Trial |
Spain | 2301537 | Start Trial |
Cyprus | 1108166 | Start Trial |
Australia | 2001255680 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |