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ABILIFY Drug Profile
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This drug has three hundred and seventy-three patent family members in forty-nine countries.
The generic ingredient in ABILIFY is aripiprazole. There are forty-one drug master file entries for this compound. Thirty-three suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the aripiprazole profile page.
Summary for Tradename: ABILIFY
| Patents: | 23 |
| Applicants: | 2 |
| NDAs: | 5 |
| Suppliers / Packagers: see list | 14 |
| Drug Prices: : | see details |
Pharmacology for Tradename: ABILIFY
| Drug Class | Atypical Antipsychotic |
Clinical Trials for: ABILIFY
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-006 | Nov 15, 2002 | RX | No | 8,017,615*PED | Dec 16, 2024 | Y | |||||||||||||||||||
Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-001 | Nov 15, 2002 | RX | Yes | Dec 12, 2021 | |||||||||||||||||||||
Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-004 | Jun 7, 2006 | DISCN | No | 9,387,182 | Dec 25, 2023 | ||||||||||||||||||||
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Expired Patents for Tradename: ABILIFY
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-004 | Nov 15, 2002 | 4,734,416 | <disabled> | ||||||||||||||||||||||
Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-004 | Nov 15, 2002 | 5,006,528*PED | <disabled> | ||||||||||||||||||||||
Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-005 | Nov 15, 2002 | 5,006,528*PED | <disabled> | ||||||||||||||||||||||
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Paragraph IV activity for: ABILIFY
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| aripiprazole | Oral Solution | 1 mg/mL | Abilify | 12/20/2007 |
| aripiprazole | Orally Disintegrating Tablets | 10 mg, 15 mg, 20 mg and 30 mg | Abilify | 11/15/2006 |
| aripiprazole | Tablets | 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg | Abilify | 11/15/2006 |
Non-Orange Book Patents for Tradename: ABILIFY
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,703,773 | Low hygroscopic aripiprazole drug substance and processes for the preparation thereof | <disabled in preview> | |||||||||||||||||||||||||||
| 8,030,312 | 5-HT1A receptor subtype agonist | <disabled in preview> | |||||||||||||||||||||||||||
| 8,993,761 | Low hygroscopic aripiprazole drug substance and processes for the preparation thereof | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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International Patent Family for Tradename: ABILIFY
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Canada | 2311734 | <disabled in preview> | |||||||||||||||||||||||||||
| China | 101423492 | <disabled in preview> | |||||||||||||||||||||||||||
| Israel | 136901 | <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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Supplementary Protection Certificates for Tradename: ABILIFY
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 427 | Luxembourg | <disabled> | PRODUCT NAME: ARIPIPRAZOLE | ||||||||||||||||||||||||||
| 00669 | Netherlands | <disabled> | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 | ||||||||||||||||||||||||||
| 0669 | Netherlands | <disabled> | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 | ||||||||||||||||||||||||||
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