ABILIFY Drug Patent Profile
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Which patents cover Abilify, and what generic alternatives are available?
Abilify is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in six NDAs. There are fifty patents protecting this drug and three Paragraph IV challenges.
This drug has three hundred and fifty-three patent family members in forty-five countries.
The generic ingredient in ABILIFY is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Abilify
A generic version of ABILIFY was approved as aripiprazole by ALEMBIC PHARMS LTD on April 28th, 2015.
Summary for ABILIFY
| International Patents: | 353 |
| US Patents: | 13 |
| Applicants: | 2 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 140 |
| Clinical Trials: | 155 |
| Patent Applications: | 4,585 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ABILIFY |
| Drug Sales Revenues: | Drug sales revenues for ABILIFY |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ABILIFY |
| What excipients (inactive ingredients) are in ABILIFY? | ABILIFY excipients list |
| DailyMed Link: | ABILIFY at DailyMed |
Recent Clinical Trials for ABILIFY
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| New Jersey Governor’s Council for Medical Research and Treatment of Autism | Phase 2 |
| Rutgers, The State University of New Jersey | Phase 2 |
| New Jersey Governor's Council for Medical Research and Treatment of Autism | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for ABILIFY
Paragraph IV (Patent) Challenges for ABILIFY
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ABILIFY | Oral Solution | aripiprazole | 1 mg/mL | 021713 | 1 | 2007-12-20 |
| ABILIFY | Tablets | aripiprazole | 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg | 021436 | 8 | 2006-11-15 |
| ABILIFY | Orally Disintegrating Tablets | aripiprazole | 10 mg, 15 mg, 20 mg and 30 mg | 021729 | 1 | 2006-11-15 |
US Patents and Regulatory Information for ABILIFY
ABILIFY is protected by eleven US patents.
Patents protecting ABILIFY
Aripiprazole oral solution
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
5-HT1a receptor subtype agonist
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Aripiprazole complex formulation and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Method of treating cognitive impairments and schizophrenias
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA
Carbostyril derivatives and mood stabilizers for treating mood disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA, ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER, ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER, AND TREATMENT OF IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-006 | Nov 13, 2017 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-002 | Nov 15, 2002 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-004 | Nov 13, 2017 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| >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 ABILIFY
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-005 | Jun 7, 2006 | See Plans and Pricing | See Plans and Pricing |
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-002 | Nov 15, 2002 | See Plans and Pricing | See Plans and Pricing |
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-004 | Nov 15, 2002 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ABILIFY
See the table below for patents covering ABILIFY around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Israel | 225902 | See Plans and Pricing | |
| South Korea | 100477293 | See Plans and Pricing | |
| Japan | 3750023 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ABILIFY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0367141 | C00367141/01 | Switzerland | See Plans and Pricing | FORMER REPRESENTATIVE: BOHEST AG, CH |
| 0367141 | 300161 | Netherlands | See Plans and Pricing | 300161, 20091027, EXPIRES: 20141026 |
| 1675573 | C300669 | Netherlands | See Plans and Pricing | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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