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Alcaftadine - Generic Drug Details

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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.

This ingredient has seventy-seven patent family members in forty-one countries.

There are five drug master file entries for alcaftadine. Three suppliers are listed for this compound.

Summary for Generic Name: alcaftadine

Tradenames:1
Patents:2
Applicants:1
NDAs:1
Drug Master File Entries: see list5
Suppliers / Packaging: see list3

Clinical Trials for: alcaftadine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan
LASTACAFT
alcaftadine
SOLUTION/DROPS;OPHTHALMIC022134-001Jul 28, 2010RXYes5,468,743<disabled>YY <disabled>
Allergan
LASTACAFT
alcaftadine
SOLUTION/DROPS;OPHTHALMIC022134-001Jul 28, 2010RXYes8,664,215<disabled> <disabled>
Allergan
LASTACAFT
alcaftadine
SOLUTION/DROPS;OPHTHALMIC022134-001Jul 28, 2010RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: alcaftadine

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan
LASTACAFT
alcaftadine
SOLUTION/DROPS;OPHTHALMIC022134-001Jul 28, 20105,468,743<disabled>
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International Patent Family for Ingredient: alcaftadine

Country Document Number Estimated Expiration
Taiwan218381<disabled in preview>
European Patent Office0588858<disabled in preview>
Canada2648115<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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