FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for fexofenadine hydrochloride; pseudoephedrine hydrochloride and what is the scope of freedom to operate?
Fexofenadine hydrochloride; pseudoephedrine hydrochloride
is the generic ingredient in three branded drugs marketed by Chattem Sanofi, Aurobindo Pharma, Barr, Dr Reddys, Dr Reddys Labs Ltd, Impax Pharms, and Sun Pharm, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.Twenty-eight suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 7 |
NDAs: | 9 |
Finished Product Suppliers / Packagers: | 28 |
Clinical Trials: | 5 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
DailyMed Link: | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sanofi | Phase 4 |
Sanofi | Phase 3 |
Dr. Reddy's Laboratories Limited | Phase 1 |
See all FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials
Generic filers with tentative approvals for FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 60MG;120MG | TABLET, EXTENDED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 60/120MG | TABLET, EXTENDED RELEASE; ORAL |
⤷ Sign Up | ⤷ Sign Up | 60MG; 120MG | TABLET, EXTENDED RELEASE; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.