OTSUKA Company Profile
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What is the competitive landscape for OTSUKA, and what generic alternatives to OTSUKA drugs are available?
OTSUKA has seventeen approved drugs.
There are fifty-six US patents protecting OTSUKA drugs.
There are one thousand and seventeen patent family members on OTSUKA drugs in fifty-four countries and forty-nine supplementary protection certificates in sixteen countries.
Summary for OTSUKA
| International Patents: | 1017 |
| US Patents: | 56 |
| Tradenames: | 15 |
| Ingredients: | 10 |
| NDAs: | 17 |
| Patent Litigation for OTSUKA: | See patent lawsuits for OTSUKA |
Drugs and US Patents for OTSUKA
| 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 MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-002 | Feb 28, 2013 | RX | Yes | Yes | 10,980,803 | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-004 | Sep 29, 2014 | RX | Yes | No | 11,648,347 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-003 | Nov 13, 2017 | RX | Yes | No | 9,258,035 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-002 | Nov 13, 2017 | RX | Yes | Yes | 8,547,248 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Otsuka | REXULTI | brexpiprazole | TABLET;ORAL | 205422-001 | Jul 10, 2015 | AB | RX | Yes | No | 9,839,637 | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-006 | Nov 15, 2002 | AB | RX | Yes | No | 9,125,939 | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-003 | Nov 13, 2017 | RX | Yes | No | 10,441,194 | ⤷ Try a Trial | Y | ⤷ Try a 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 OTSUKA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-002 | Nov 15, 2002 | 4,734,416 | ⤷ Try a Trial |
| Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-001 | Apr 23, 2018 | 5,972,882 | ⤷ Try a Trial |
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-001 | Nov 15, 2002 | 7,053,092 | ⤷ Try a Trial |
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-004 | Jun 7, 2006 | 5,006,528*PED | ⤷ Try a Trial |
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-005 | Nov 15, 2002 | 9,089,567 | ⤷ Try a Trial |
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-001 | Feb 28, 2013 | 8,993,761 | ⤷ Try a Trial |
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-003 | Nov 13, 2017 | 9,089,567 | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for OTSUKA drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg | ➤ Subscribe | 2006-11-15 |
| ➤ Subscribe | Tablets | 15 mg and 30 mg | ➤ Subscribe | 2013-09-23 |
| ➤ Subscribe | Injection | 6 mg/mL | ➤ Subscribe | 2012-12-26 |
| ➤ Subscribe | Oral Solution | 1 mg/mL | ➤ Subscribe | 2007-12-20 |
| ➤ Subscribe | Orally Disintegrating Tablets | 10 mg, 15 mg, 20 mg and 30 mg | ➤ Subscribe | 2006-11-15 |
| ➤ Subscribe | Tablets | 60 mg | ➤ Subscribe | 2018-03-26 |
International Patents for OTSUKA Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 1794994 | ⤷ Try a Trial |
| Japan | 2014139203 | ⤷ Try a Trial |
| Mexico | 2013008433 | ⤷ Try a Trial |
| European Patent Office | 2667856 | ⤷ Try a Trial |
| China | 102724948 | ⤷ Try a Trial |
| South Korea | 20090076941 | ⤷ Try a Trial |
| Hong Kong | 1136958 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for OTSUKA Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1869025 | 1890028-2 | Sweden | ⤷ Try a Trial | PRODUCT NAME: BREXPIPRAZOLE, OR A SALT THEREOF; REG. NO/DATE: EU/1/18/1294 20180730 |
| 1869025 | C20180022 00264 | Estonia | ⤷ Try a Trial | PRODUCT NAME: BREKSPIPRASOOL;REG NO/DATE: EU/1/18/1294 30.07.2018 |
| 1675573 | C300669 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| 2207786 | LUC00326 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: COMPOSITION COMPRENANT: DE LA CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; ET DE LA DECITABINE; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230913 |
| 1675573 | 32/2014 | Austria | ⤷ Try a Trial | PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 (MITTEILUNG) 20131119 |
| 1869025 | PA2018509 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726 |
| 1869025 | SPC/GB18/038 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: BREXPIPRAZOLE OR A SALT THEREOF; REGISTERED: UK EU/1/18/1294/001(NI) 20180730; UK PLGB 506970019 20180730; UK PLGB 506970020 20180730; UK PLGB 506970021 20180730; UK PLGB 506970022 20180730; UK PLGB 506970023 20180730; UK EU/1/18/1294/007(NI) 20180730; UK EU/1/18/1294/008(NI) 20180730; UK EU/1/18/1294/009(NI) 20180730; UK EU/1/18/1294/010(NI) 20180730; UK EU/1/18/1294/011(NI) 20180730; UK PLGB 506970024 20180730; UK EU/1/18/1294/002(NI) 20180730; UK EU/1/18/1294/003(NI) 20180730; UK EU/1/18/1294/004(NI) 20180730; UK EU/1/18/1294/005(NI) 20180730; UK EU/1/18/1294/006(NI) 20180730 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
