DrugPatentWatch Database Preview
ABILIFY Drug 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 forty-nine patents protecting this drug and three Paragraph IV challenges.
The generic ingredient in ABILIFY is aripiprazole. There are forty-six drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for ABILIFY
| US Patents: | 15 |
| Applicants: | 2 |
| NDAs: | 6 |
| Suppliers / Packagers: | 9 |
| Bulk Api Vendors: | 113 |
| Clinical Trials: | 59 |
| Patent Applications: | 3,583 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ABILIFY |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ABILIFY |
| DailyMed Link: | ABILIFY at DailyMed |
Pharmacology for ABILIFY
| Drug Class | Atypical Antipsychotic |
Medical Subject Heading (MeSH) Categories for ABILIFY
Synonyms for ABILIFY
| 129722-12-9 |
| 2(1H)-Quinolinone, 7-(4-(4-(2,3-dichlorophenyl)-1-piperazinyl)butoxy)-3,4-dihydro- |
| 2(1H)-Quinolinone, 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro- |
| 24-29-3 |
| 4811-EP2269990A1 |
| 4811-EP2272841A1 |
| 4811-EP2298731A1 |
| 4811-EP2298776A1 |
| 4811-EP2301936A1 |
| 7-(4-(4-(2,3-Dichlorophenyl)-1-piperazinyl)butoxy)-3,4-dihydro-2(1H)-quinolinone |
| 7-(4-(4-(2,3-Dichlorophenyl)-1-piperazinyl)butoxy)-3,4-dihydrocarbostyril |
| 7-(4-(4-(2,3-Dichlorophenyl)-1-piperazinyl)butyloxy)-3,4-dihydro-2(1H)-quinolinone |
| 7-(4-(4-(2,3-DICHLOROPHENYL)PIPERAZIN-1-YL)BUTOXY)-3,4-DIHYDROQUINOLIN-2(1H)-ONE |
| 7-(4-[4-(2,3-DICHLORO-PHENYL)-PIPERAZIN-1-YL]-BUTOXY)-3,4-DIHYDRO-1H-QUINOLIN-2-ONE |
| 7-(4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy)-3,4-dihydrocarbostyril |
| 7-(4-[4-(2,3-DICHLOROPHENYL)PIPERAZIN-1-YL]BUTOXY)-1,2,3,4-TETRAHYDROQUINOLIN-2-ONE |
| 7-(4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy)-3,4-dihydroquinolin-2(1H)-one |
| 7-[4-(4-(2,3-Dichlorophenyl)piperazin-1-yl)butoxy]-3,4-dihydro-2(1H)-quinolinone |
| 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone |
| 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril |
| 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril; 7-{4-[4-(2,3-Dichlorophenyl)piperazin-1-yl]butoxy}-3,4-dihydroquinolin-2(1H)-one |
| 7-[4-[4-(2,3-Dichlorophenyl)-1-Piperazinyl]Butoxy]3,4-Dihydro-2(1H)-Quinolinone |
| 7-[4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy]-3,4-dihydro-1H-quinolin-2-one |
| 7-[4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy]-3,4-dihydro-quinolin-2(1H)-one |
| 7-{4-[-4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy}-3,4-dihydrocarbostyril |
| 7-{4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy}-3, 4-dihydrocarbostyril |
| 7-{4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy}-3,4-dihydrocarbostyril |
| 7-{4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy}-1,2,3,4-tetrahydroquinolin-2-one |
| 7-{4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy}-3,4-dihydroquinolin-2(1H)-one |
| 7-{4-[4-(2,3-dichlorophenyl)piperazino]butoxy}-3,4-dihydro-2(1H)-quinolinone |
| 722A129 |
| 82VFR53I78 |
| A19454 |
| AB0008434 |
| AB00639935_10 |
| AB00639935_11 |
| AB00639935-09 |
| AB07660 |
| AB1006698 |
| Abilify (TN) |
| Abilify Digital |
| Abilify Discmelt |
| Abilify Maintena |
| Abilify Maintena Kit |
| Abilify MyCite |
| Abilify OD |
| Abilitat |
| AC-1554 |
| AC1L1TXZ |
| AC1Q3T38 |
| ACMC-20emtv |
| ACT03221 |
| AJ-32089 |
| AK-46736 |
| AKOS005558247 |
| ALKS-9070 |
| ALKS-9072 |
| ALKS9070/ALKS9072 |
| AM20090766 |
| AN-902 |
| AOB5922 |
| aripiprazol |
| Aripiprazole |
| Aripiprazole (Abilify) |
| Aripiprazole (JAN/USAN/INN) |
| Aripiprazole [USAN:INN:BAN] |
| Aripiprazole [USAN] |
| Aripiprazole 1.0 mg/ml in Acetonitrile |
| Aripiprazole Depot |
| Aripiprazole hydrate |
| Aripiprazole solution, 1.0 mg/mL (1:1 Methanol/Water with 1% 1N HCl), ampule of 1 mL, certified reference material |
| Aripiprazole solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material |
| Aripiprazole-d8 |
| Aripiprazole; |
| Aripiprazole/escitalopram fixed-dose combination |
| aripiprazolum |
| Aripiprex |
| Aripirazole |
| Arpizol |
| Asprito |
| BBL029082 |
| BC208491 |
| BCP9000317 |
| BDBM50130293 |
| Bio-0004 |
| BMS-337039 |
| BR-46736 |
| Bristol-Myers Squibb brand of aripiprazole |
| C12564 |
| C23H27Cl2N3O2 |
| CA0141 |
| CAS-129722-12-9 |
| CCG-100891 |
| CEUORZQYGODEFX-UHFFFAOYSA-N |
| CHEBI:31236 |
| CHEMBL1112 |
| CPD000466383 |
| CS-0766 |
| CTK0H5518 |
| D01164 |
| D0H3HM |
| D0P8CI |
| D0Y2GK |
| DB01238 |
| DEHYDROARIPIPRAZOL |
| Discmelt |
| Discmelt (TN) |
| DL-178 |
| DSSTox_CID_26083 |
| DSSTox_GSID_46083 |
| DSSTox_RID_81324 |
| DTXSID3046083 |
| EBD20357 |
| FC0025 |
| FT-0082572 |
| FT-0600352 |
| GTPL34 |
| HE017185 |
| HE328075 |
| HMS2051I18 |
| HMS2089M20 |
| HMS2093F22 |
| HMS2230M18 |
| HMS3373D04 |
| HMS3393I18 |
| HMS3657K13 |
| HSDB 7320 |
| HY-14546 |
| J-005707 |
| J10066 |
| KB-47438 |
| KS-00000XK7 |
| KS-1030 |
| L001339 |
| LP071262 |
| LS-142666 |
| MCULE-4329329262 |
| MFCD00892072 |
| MLS000759517 |
| MLS001165779 |
| MLS001195621 |
| MLS001424078 |
| MLS006011892 |
| MolPort-002-885-808 |
| NC00141 |
| NCGC00159510-02 |
| NCGC00159510-03 |
| NCGC00159510-04 |
| NCGC00159510-05 |
| NSC-759266 |
| NSC759266 |
| Opc 14597 |
| OPC 31 |
| OPC-14597 |
| OPC-31 |
| Otsuka brand of aripiprazole |
| Pharmakon1600-01505851 |
| Pripiprazole |
| PubChem18143 |
| RTR-004086 |
| S-4507 |
| S06-0010 |
| s1975 |
| SAM001246750 |
| SBI-0206870.P001 |
| SC-16317 |
| SCHEMBL12961254 |
| SCHEMBL5335696 |
| SCHEMBL8255 |
| SMR000466383 |
| ST2412627 |
| STK625160 |
| TL8000707 |
| TL80090184 |
| Tox21_111728 |
| Tox21_111728_1 |
| UNII-82VFR53I78 |
| Z1541632800 |
| ZINC1851149 |
US Patents and Regulatory Information for ABILIFY
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Otsuka Pharm Co Ltd | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-006 | Nov 13, 2017 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-005 | Nov 15, 2002 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Otsuka Pharm Co Ltd | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-004 | Nov 13, 2017 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Otsuka Pharm Co Ltd | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-002 | Nov 13, 2017 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-003 | Nov 15, 2002 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Otsuka Pharm Co Ltd | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-003 | Nov 13, 2017 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Expired US Patents for ABILIFY
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-006 | Nov 15, 2002 | ➤ Sign Up | ➤ Sign Up |
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-006 | Nov 15, 2002 | ➤ Sign Up | ➤ Sign Up |
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-001 | Nov 15, 2002 | ➤ Sign Up | ➤ Sign Up |
| Otsuka | ABILIFY | aripiprazole | INJECTABLE;INTRAMUSCULAR | 021866-001 | Sep 20, 2006 | ➤ Sign Up | ➤ Sign Up |
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-003 | Jun 7, 2006 | ➤ Sign Up | ➤ Sign Up |
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-004 | Nov 15, 2002 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for ABILIFY
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Oral Solution | 1 mg/mL | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Tablets | 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Orally Disintegrating Tablets | 10 mg, 15 mg, 20 mg and 30 mg | ➤ Subscribe | ➤ Sign Up |
Non-Orange Book US Patents for 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 |
|---|---|---|
| 7,910,589 | Low hygroscopic aripiprazole drug substance and processes for the preparation thereof | ➤ Sign Up |
| 8,399,469 | Low hygroscopic aripiprazole drug substance and processes for the preparation thereof | ➤ Sign Up |
| 8,901,303 | Low hygroscopic aripiprazole drug substance and processes for the preparation thereof | ➤ Sign Up |
| 8,030,312 | 5-HT1A receptor subtype agonist | ➤ Sign Up |
| 8,680,105 | Method of treating down's syndrome | ➤ Sign Up |
| 8,623,874 | Method of treating neurodegenerative diseases | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for ABILIFY
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Norway | 20141193 | ➤ Sign Up |
| China | 102172401 | ➤ Sign Up |
| Cyprus | 1110208 | ➤ Sign Up |
| South Africa | 200503873 | ➤ Sign Up |
| Japan | 2004532225 | ➤ Sign Up |
| Poland | 211975 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for ABILIFY
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 427 | Luxembourg | ➤ Sign Up | PRODUCT NAME: ARIPIPRAZOLE |
| 00669 | Netherlands | ➤ Sign Up | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| 0669 | Netherlands | ➤ Sign Up | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| C/GB04/039 | United Kingdom | ➤ Sign Up | PRODUCT NAME: ARIPIPRAZOLE OR A SALT THEREOF; REGISTERED: UK EU/1/04/276/001 20040604; UK EU/1/04/276/002 20040604; UK EU/1/04/276/003 20040604; UK EU/1/04/276/004 20040604; UK EU/1/04/276/005 20040604; UK EU/1/04/276/006 20040604; UK EU/1/04/276/007 20040604; UK EU/1/04/276/008 20040604; UK EU/1/04/276/009 20040604; UK EU/1/04/276/010 20040604; UK EU/1/04/276/011 20040604; UK EU/1/04/276/012 20040604; UK EU/1/04/276/013 20040604; UK EU/1/04/276/014 20040604; UK EU/1/04/276/015 20040604; UK EU/1/04/276/016 20040604; UK EU/1/04/276/017 20040604; UK EU/1/04/276/018 20040604; UK EU/1/04/276/019 20040604; UK EU/1/04/276/020 20040604 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
