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Last Updated: August 9, 2020

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ALCAFTADINE - Generic Drug Details

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What are the generic sources for alcaftadine and what is the scope of freedom to operate?

Alcaftadine is the generic ingredient in one branded drug marketed by Allergan and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alcaftadine has forty-six patent family members in thirty countries.

There are six drug master file entries for alcaftadine. One supplier is listed for this compound.

Recent Clinical Trials for ALCAFTADINE

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

SponsorPhase
AllerganN/A
Starx Research Center, LLCPhase 4
AllerganPhase 4

See all ALCAFTADINE clinical trials

Pharmacology for ALCAFTADINE
Paragraph IV (Patent) Challenges for ALCAFTADINE
Tradename Dosage Ingredient NDA Submissiondate
LASTACAFT SOLUTION/DROPS;OPHTHALMIC alcaftadine 022134 2014-07-30

US Patents and Regulatory Information for ALCAFTADINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan LASTACAFT alcaftadine SOLUTION/DROPS;OPHTHALMIC 022134-001 Jul 28, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan LASTACAFT alcaftadine SOLUTION/DROPS;OPHTHALMIC 022134-001 Jul 28, 2010 RX Yes Yes   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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Johnson and Johnson
Colorcon
Harvard Business School
McKinsey

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