Fexofenadine hydrochloride - Generic Drug Details
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What are the generic sources for fexofenadine hydrochloride and what is the scope of patent protection?
Fexofenadine hydrochloride
is the generic ingredient in thirteen branded drugs marketed by Chattem Sanofi, Barr, P And L, Taro, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Rising, Sun Pharm Inds, Teva, Wockhardt, L Perrigo Co, Granules, Sciegen Pharms Inc, Unique, Aurobindo Pharma, Dr Reddys, Impax Pharms, and Sun Pharm, and is included in thirty-two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Fexofenadine hydrochloride has forty-three patent family members in thirty-eight countries.
There are twenty-one drug master file entries for fexofenadine hydrochloride. One hundred and four suppliers are listed for this compound. There are six tentative approvals for this compound.
Summary for fexofenadine hydrochloride
International Patents: | 43 |
US Patents: | 1 |
Tradenames: | 13 |
Applicants: | 19 |
NDAs: | 32 |
Drug Master File Entries: | 21 |
Finished Product Suppliers / Packagers: | 104 |
Raw Ingredient (Bulk) Api Vendors: | 127 |
Clinical Trials: | 79 |
Patent Applications: | 2,621 |
What excipients (inactive ingredients) are in fexofenadine hydrochloride? | fexofenadine hydrochloride excipients list |
DailyMed Link: | fexofenadine hydrochloride at DailyMed |
Recent Clinical Trials for fexofenadine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Bristol-Myers Squibb | Phase 1 |
Dhaka Medical College | Phase 2/Phase 3 |
Opella Healthcare Group SAS, a Sanofi Company | Phase 3 |
Generic filers with tentative approvals for FEXOFENADINE 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 | 180MG | TABLET; 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
Drug Class | Histamine-1 Receptor Antagonist |
Mechanism of Action | Histamine H1 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for fexofenadine hydrochloride
Paragraph IV (Patent) Challenges for FEXOFENADINE HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
CHILDREN'S ALLEGRA HIVES | Oral Suspension (OTC) | fexofenadine hydrochloride | 30 mg/5 mL | 201373 | 1 | 2010-01-25 |
US Patents and Regulatory Information for fexofenadine hydrochloride
Expired US Patents for fexofenadine hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Chattem Sanofi | CHILDREN'S ALLEGRA HIVES | fexofenadine hydrochloride | TABLET;ORAL | 020872-006 | Jan 24, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Chattem Sanofi | CHILDREN'S ALLEGRA HIVES | fexofenadine hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021909-003 | Jan 24, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Chattem Sanofi | CHILDREN'S ALLEGRA HIVES | fexofenadine hydrochloride | TABLET;ORAL | 020872-006 | Jan 24, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Chattem Sanofi | ALLEGRA | fexofenadine hydrochloride | CAPSULE;ORAL | 020625-001 | Jul 25, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for fexofenadine hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 1965768 | ⤷ Sign Up | |
Ecuador | SP088532 | FORMULACIÓN DE SUSPENSIÓN DE FEXOFENADINA | ⤷ Sign Up |
Norway | 339877 | ⤷ Sign Up | |
Portugal | 1965768 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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