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Last Updated: September 23, 2020

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Fexofenadine hydrochloride - Generic Drug Details

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What are the generic drug sources for fexofenadine hydrochloride and what is the scope of patent protection?

Fexofenadine hydrochloride is the generic ingredient in thirteen branded drugs marketed by Sanofi Aventis Us, Barr, P And L, Taro, Dr Reddys Labs Ltd, Aurolife Pharma Llc, Hetero Labs Ltd V, Mylan, Sun Pharm Inds, Teva, Wockhardt Ltd, L Perrigo Co, Granules India Ltd, Sciegen Pharms Inc, Unique Pharm Labs, Aurobindo Pharma Ltd, Impax Pharms, and Sun Pharm, and is included in thirty NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fexofenadine hydrochloride has sixty-two patent family members in thirty-nine countries.

There are twenty-three drug master file entries for fexofenadine hydrochloride. One hundred and three suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for fexofenadine hydrochloride
Recent Clinical Trials for fexofenadine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Tanta UniversityPhase 4
Assistance Publique - Hôpitaux de ParisPhase 4
BayerPhase 1

See all fexofenadine hydrochloride clinical trials

Generic filers with tentative approvals for FEXOFENADINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial60MG;120MGTABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial60/120MGTABLET, EXTENDED RELEASE; ORAL
  Start Trial  Start Trial180MGTABLET; 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
Paragraph IV (Patent) Challenges for FEXOFENADINE HYDROCHLORIDE

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
Sun Pharm Inds FEXOFENADINE HYDROCHLORIDE HIVES fexofenadine hydrochloride TABLET;ORAL 091567-003 Feb 6, 2012 OTC No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd FEXOFENADINE HYDROCHLORIDE fexofenadine hydrochloride TABLET;ORAL 076502-001 Apr 11, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
P And L FEXOFENADINE HYDROCHLORIDE fexofenadine hydrochloride SUSPENSION;ORAL 201311-001 Jul 25, 2012 DISCN 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 fexofenadine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us ALLEGRA HIVES fexofenadine hydrochloride TABLET;ORAL 020872-008 Jan 24, 2011   Start Trial   Start Trial
Sanofi Aventis Us ALLEGRA HIVES fexofenadine hydrochloride TABLET;ORAL 020872-008 Jan 24, 2011   Start Trial   Start Trial
Sanofi Aventis Us CHILDREN'S ALLEGRA HIVES fexofenadine hydrochloride TABLET;ORAL 020872-006 Jan 24, 2011   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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