FEXOFENADINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Fexofenadine Hydrochloride, and what generic alternatives are available?
Fexofenadine Hydrochloride is a drug marketed by Barr, Aurobindo Pharma Ltd, P And L, Dr Reddys Labs Ltd, L Perrigo Co, Rising, Teva, Granules, Hetero Labs Ltd V, Sciegen Pharms Inc, Sun Pharm Inds, Unique, Wockhardt, Aurobindo Pharma, Dr Reddys, Impax Pharms, and Sun Pharm. and is included in twenty-two NDAs.
The generic ingredient in FEXOFENADINE HYDROCHLORIDE is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fexofenadine Hydrochloride
A generic version of FEXOFENADINE HYDROCHLORIDE was approved as fexofenadine hydrochloride; pseudoephedrine hydrochloride by DR REDDYS LABS LTD on June 22nd, 2011.
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Questions you can ask:
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Summary for FEXOFENADINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 17 |
| NDAs: | 22 |
| Finished Product Suppliers / Packagers: | 38 |
| Raw Ingredient (Bulk) Api Vendors: | 127 |
| Clinical Trials: | 79 |
| Patent Applications: | 1,698 |
| 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 |
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva | FEXOFENADINE HYDROCHLORIDE ALLERGY | fexofenadine hydrochloride | TABLET;ORAL | 076447-006 | Apr 13, 2011 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sciegen Pharms Inc | FEXOFENADINE HYDROCHLORIDE HIVES | fexofenadine hydrochloride | TABLET;ORAL | 204507-005 | Sep 16, 2015 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Dr Reddys Labs Ltd | FEXOFENADINE HYDROCHLORIDE HIVES | fexofenadine hydrochloride | TABLET;ORAL | 076502-009 | Apr 12, 2011 | OTC | No | 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 |
