FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details
✉ Email this page to a colleague
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 |
⤷ Subscribe | ⤷ Subscribe | 60MG;120MG | TABLET, EXTENDED RELEASE;ORAL |
⤷ Subscribe | ⤷ Subscribe | 60/120MG | TABLET, EXTENDED RELEASE; ORAL |
⤷ Subscribe | ⤷ Subscribe | 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.
Pharmacology for FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Class | Histamine-1 Receptor Antagonist alpha-Adrenergic Agonist |
Mechanism of Action | Adrenergic alpha-Agonists Histamine H1 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
US Patents and Regulatory Information for FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Barr | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 076236-001 | Apr 14, 2005 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Dr Reddys | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 076667-001 | Nov 18, 2014 | OTC | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Chattem Sanofi | ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020786-002 | Jan 24, 2011 | OTC | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Dr Reddys Labs Ltd | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 079043-002 | Jun 22, 2011 | OTC | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
>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 FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Chattem Sanofi | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021704-002 | Jan 24, 2011 | 5,578,610*PED | ⤷ Subscribe |
Chattem Sanofi | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021704-002 | Jan 24, 2011 | 6,613,357 | ⤷ Subscribe |
Chattem Sanofi | ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020786-002 | Jan 24, 2011 | 6,113,942*PED | ⤷ Subscribe |
Chattem Sanofi | ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION | fexofenadine hydrochloride; pseudoephedrine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020786-002 | Jan 24, 2011 | 7,138,524*PED | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental
More… ↓
Make Better Decisions: Try a trial or see plans & pricing
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.