Otsuka Company Profile
✉ Email this page to a colleague
What is the competitive landscape for OTSUKA, and when can generic versions of OTSUKA drugs launch?
OTSUKA has seventeen approved drugs.
There are fifty-six US patents protecting OTSUKA drugs.
There are one thousand and eighteen patent family members on OTSUKA drugs in fifty-four countries and forty-nine supplementary protection certificates in sixteen countries.
Summary for Otsuka
| International Patents: | 1018 |
| 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 | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-006 | Nov 13, 2017 | RX | Yes | No | 8,017,615 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-001 | Nov 13, 2017 | RX | Yes | No | 8,545,402 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-004 | Nov 13, 2017 | RX | Yes | No | 8,847,766 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-002 | Apr 23, 2018 | RX | Yes | No | 8,501,730 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-003 | May 19, 2009 | DISCN | Yes | No | 10,905,694 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Otsuka | REXULTI | brexpiprazole | TABLET;ORAL | 205422-003 | Jul 10, 2015 | AB | RX | Yes | No | 8,349,840 | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Otsuka | PLETAL | cilostazol | TABLET;ORAL | 020863-002 | Jan 15, 1999 | DISCN | Yes | No | ⤷ 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 |
Expired US Patents for Otsuka
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-004 | Apr 23, 2018 | 5,972,882 | ⤷ Sign Up |
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-002 | Jun 7, 2006 | 9,359,302 | ⤷ Sign Up |
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-004 | Sep 29, 2014 | 8,759,351 | ⤷ Sign Up |
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-003 | Nov 15, 2002 | 8,642,760*PED | ⤷ Sign Up |
| Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-005 | Apr 23, 2018 | 5,972,882 | ⤷ Sign Up |
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-003 | Sep 29, 2014 | 5,006,528*PED | ⤷ Sign Up |
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-001 | Nov 15, 2002 | 9,359,302 | ⤷ Sign Up |
| >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 | 100335047 | ⤷ Sign Up |
| Israel | 189481 | ⤷ Sign Up |
| South Africa | 201207592 | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2008052136 | ⤷ Sign Up |
| Cyprus | 1110244 | ⤷ Sign Up |
| Russian Federation | 2014104692 | ⤷ Sign Up |
| Lithuania | PA2018509 | ⤷ Sign Up |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Otsuka Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0287951 | SPC/GB98/016 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: GREPAFLOXACIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT INCLUDING GREPAFLOXACIN HYDROCHLORIDE SESQUIHYDRATE; REGISTERED: DE 40682.00.00 19970731; DE 40682.01.00 19970731; DE 40682.02.00 19970731; UK 10949/0299 19971209; UK 10949/0300 19971209 |
| 0287951 | C980011 | Netherlands | ⤷ Sign Up | PRODUCT NAME: GREPAFLOXACINUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AA NVAARDBAAR ZOUT OF IN DE VORM VAN EEN ESTER MET EEN ALKANOL MET 1-6 KOOLSTOFATOMEN, IN HET BIJZONDER GREPAFLOXACINI HYDROCHLOR IDUM SESQUIHYDRATUM; NAT. REGISTRATION NO/DATE: RVG 21894, RVG 21895 19971113; FIRST REGISTRATION: DE 40682.00.00, 40682.01.00, 40682.02.00 19970731 |
| 1675573 | C20140014 00322 | Estonia | ⤷ Sign Up | PRODUCT NAME: ARIPIPRASOOL;REG NO/DATE: K(2013)8163 (LOPLIK) 19.11.2013 |
| 1675573 | 2014C/029 | Belgium | ⤷ Sign Up | PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119 |
| 1869025 | 32/2018 | Austria | ⤷ Sign Up | PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 (MITTEILUNG) 20180727 |
| 1869025 | 2018C/037 | Belgium | ⤷ Sign Up | PRODUCT NAME: BREXPIPRAZOL OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730 |
| 2207786 | CA 2023 00038 | Denmark | ⤷ Sign Up | PRODUCT NAME: SAMMENSAETNING OMFATTENDE CEDAZURIDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; OG DECITABIN; REG. NO/DATE: EU/1/23/1756 20230918 |
| >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.
