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Last Updated: March 18, 2024

Alcaftadine - Generic Drug Details


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What are the generic sources for alcaftadine and what is the scope of patent protection?

Alcaftadine is the generic ingredient in two branded drugs marketed by Eugia Pharma and Abbvie, and is included in two NDAs. 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. Two suppliers are listed for this compound.

Summary for alcaftadine
Recent Clinical Trials for alcaftadine

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

SponsorPhase
Allergan
Starx Research Center, LLCPhase 4
AllerganPhase 4

See all alcaftadine clinical trials

Pharmacology for alcaftadine
Paragraph IV (Patent) Challenges for ALCAFTADINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LASTACAFT Ophthalmic Solution alcaftadine 0.25% 022134 1 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
Abbvie LASTACAFT alcaftadine SOLUTION/DROPS;OPHTHALMIC 022134-001 Jul 28, 2010 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Eugia Pharma ALCAFTADINE alcaftadine SOLUTION/DROPS;OPHTHALMIC 210659-001 Jun 23, 2023 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie LASTACAFT alcaftadine SOLUTION/DROPS;OPHTHALMIC 022134-001 Jul 28, 2010 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for alcaftadine

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 016221 ОФТАЛЬМИЧЕСКИЕ КОМПОЗИЦИИ И СПОСОБ ЛЕЧЕНИЯ АЛЛЕРГИЧЕСКИХ ЗАБОЛЕВАНИЙ ГЛАЗ (OPHTHALMIC COMPOSITIONS AND METHOD OF TREATING OCULAR ALLERGIES) ⤷  Try a Trial
South Africa 200809327 OCULAR ALLERGY TREATMENTS ⤷  Try a Trial
European Patent Office 3150209 TRAITEMENTS D'ALLERGIE OCULAIRE (OCULAR ALLERGY TREATMENTS) ⤷  Try a Trial
China 101460176 Ocular allergy treatments ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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