DrugPatentWatch Database Preview
ABILIFY Drug Profile
Which patents cover Abilify, and when can generic versions of Abilify launch?
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 four hundred and twenty-eight patent family members in fifty-one countries.
The generic ingredient in ABILIFY is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for ABILIFY
| International Patents: | 428 |
| US Patents: | 15 |
| Applicants: | 2 |
| NDAs: | 6 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 124 |
| Clinical Trials: | 68 |
| Patent Applications: | 3,975 |
| 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 |
| DailyMed Link: | ABILIFY at DailyMed |
Recent Clinical Trials for ABILIFY
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| New York State Institute for Basic Research | 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 |
Recent Litigation for ABILIFY
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| OTSUKA PHARMACEUTICAL CO. LTD. v. ORCHID PHARMA LTD. | 2016-12-30 |
| OTSUKA PHARMACEUTICAL CO., LTD. v. ALKEM LABORATORIES LIMITED | 2016-09-26 |
| Otsuka Pharmaceutical Co. v. Zydus Pharmaceuticals USA | 2016-05-03 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Alkermes Pharma Ireland Limited | 2016-11-17 |
Pharmacology for ABILIFY
| Drug Class | Atypical Antipsychotic |
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-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)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-bis(chloranyl)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)-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 |
| 9SC |
| 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 |
| 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 D8 |
| Aripiprazole Depot |
| Aripiprazole solution, 1.0 mg/mL (50:50 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; |
| aripiprazolum |
| Aripiprex |
| Aripirazole |
| Aristada (aripiprazole lauroxil) |
| BBL029082 |
| BC208491 |
| BCP04902 |
| BCP9000317 |
| BDBM50130293 |
| BMS-337039 |
| BR-46736 |
| BRD-K70358946-001-06-6 |
| C12564 |
| C23H27Cl2N3O2 |
| CA0141 |
| CAS-129722-12-9 |
| CCG-100891 |
| CEUORZQYGODEFX-UHFFFAOYSA-N |
| CHEBI:31236 |
| CHEMBL1112 |
| CPD000466383 |
| CS-0766 |
| CTK0H5518 |
| D01164 |
| DB01238 |
| Discmelt |
| DL-178 |
| DSSTox_CID_26083 |
| DSSTox_GSID_46083 |
| DSSTox_RID_81324 |
| DTXSID3046083 |
| EBD20357 |
| FC0025 |
| FT-0082572 |
| FT-0600352 |
| GTPL34 |
| HMS2051I18 |
| HMS2089M20 |
| HMS2093F22 |
| HMS2230M18 |
| HMS3373D04 |
| HMS3393I18 |
| HMS3657K13 |
| HMS3715J07 |
| HSDB 7320 |
| HY-14546 |
| J-005707 |
| J10066 |
| KB-47438 |
| KS-00000XK7 |
| KS-1030 |
| L001339 |
| LS-142666 |
| MCULE-4329329262 |
| MFCD00892072 (97%) |
| MLS000759517 |
| MLS001165779 |
| MLS001195621 |
| MLS001424078 |
| MLS006011892 |
| MolPort-002-885-808 |
| NC00141 |
| NCGC00159510-02 |
| NCGC00159510-03 |
| NCGC00159510-04 |
| NCGC00159510-05 |
| NSC-759266 |
| NSC759266 |
| Opc 14597 |
| OPC 14597; OPC 31 |
| OPC 31 |
| OPC-14597 |
| OPC-31 |
| Pharmakon1600-01505851 |
| PubChem18143 |
| RTR-004086 |
| S-4507 |
| S06-0010 |
| s1975 |
| SAM001246750 |
| SBI-0206870.P001 |
| SC-16317 |
| SCHEMBL12961254 |
| SCHEMBL5335696 |
| SCHEMBL8255 |
| SMR000466383 |
| SR-01000759353 |
| SR-01000759353-4 |
| SR-01000759353-6 |
| ST2412627 |
| STK625160 |
| SW197521-3 |
| SY053146 |
| 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 | Start Trial | Start Trial | Y | Start Trial | |||
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-005 | Nov 15, 2002 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | |
| Otsuka Pharm Co Ltd | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-004 | Nov 13, 2017 | RX | Yes | No | Start Trial | 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 ABILIFY
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-005 | Nov 15, 2002 | Start Trial | Start Trial |
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-006 | Nov 15, 2002 | Start Trial | Start Trial |
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-004 | Nov 15, 2002 | Start Trial | Start Trial |
| >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 | Start Trial |
| ➤ Subscribe | Orally Disintegrating Tablets | 10 mg, 15 mg, 20 mg and 30 mg | ➤ Subscribe | Start Trial |
| ➤ Subscribe | Tablets | 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg | ➤ Subscribe | Start Trial |
International Patents for ABILIFY
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2389490 | Start Trial |
| China | 1726039 | Start Trial |
| South Korea | 20040053372 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ABILIFY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1675573 | C300669 | Netherlands | Start Trial | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| 1675573 | 300669 | Netherlands | Start Trial | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| 1675573 | 2014C/029 | Belgium | Start Trial | PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
