alcaftadine - Profile
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What are the generic drug sources for alcaftadine and what is the scope of patent protection?
Alcaftadine
is the generic ingredient in two branded drugs marketed by Alembic, Eugia Pharma, Gland, and Abbvie, and is included in four 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.
Summary for alcaftadine
| International Patents: | 46 |
| US Patents: | 2 |
| Tradenames: | 2 |
| Applicants: | 4 |
| NDAs: | 4 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alembic | ALCAFTADINE | alcaftadine | SOLUTION/DROPS;OPHTHALMIC | 209290-001 | Oct 2, 2024 | OTC | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Eugia Pharma | ALCAFTADINE | alcaftadine | SOLUTION/DROPS;OPHTHALMIC | 210659-001 | Jun 23, 2023 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Gland | ALCAFTADINE | alcaftadine | SOLUTION/DROPS;OPHTHALMIC | 209706-001 | Mar 1, 2024 | OTC | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Abbvie | LASTACAFT | alcaftadine | SOLUTION/DROPS;OPHTHALMIC | 022134-001 | Jul 28, 2010 | OTC | Yes | Yes | 8,664,215 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Abbvie | LASTACAFT | alcaftadine | SOLUTION/DROPS;OPHTHALMIC | 022134-001 | Jul 28, 2010 | OTC | Yes | Yes | 10,617,695 | ⤷ Start Trial | Y | ⤷ 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 alcaftadine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | LASTACAFT | alcaftadine | SOLUTION/DROPS;OPHTHALMIC | 022134-001 | Jul 28, 2010 | 5,468,743 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for alcaftadine
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 060278 | TRATAMIENTOS DE LAS ALERGIAS OCULARES | ⤷ Start Trial |
| Argentina | 111697 | COMPOSICIÓN OFTÁLMICA PARA EL TRATAMIENTO DE LAS ALERGIAS OCULARES | ⤷ Start Trial |
| Australia | 2007234957 | Ocular allergy treatments | ⤷ Start Trial |
| Brazil | PI0710085 | tratamentos de alergia ocular | ⤷ Start Trial |
| Canada | 2648115 | TRAITEMENTS DE L'ALLERGIE OCULAIRE (OCULAR ALLERGY TREATMENTS) | ⤷ Start Trial |
| Chile | 2007000916 | Uso de alcaftadina y de acido 6,11-dihidro-11-(1-metil-4-piperidiniliden)-5h-imidazo[2,1-b][3]benzazepin-3-carboxilico, sales, n-oxidos, solvatos e hidratos para tratar sintomas de alergia ocular, inflamacion ocular y sintomas nasales de alergia ocular; composiciones oftalmicas que los comprenden; su uso y kit farmaceutico. | ⤷ Start Trial |
| China | 101460176 | Ocular allergy treatments | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
