Otsuka Company Profile
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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 | 11,464,423 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-005 | Nov 13, 2017 | RX | Yes | No | 8,945,005 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Otsuka | ABILIFY | aripiprazole | SOLUTION;ORAL | 021713-001 | Dec 10, 2004 | DISCN | Yes | No | 8,759,350 | ⤷ Sign Up | ⤷ Sign Up | ||||
| Otsuka | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-002 | Apr 23, 2018 | RX | Yes | No | 8,501,730 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-003 | Sep 29, 2014 | RX | Yes | No | 11,344,547 | ⤷ Sign Up | ⤷ Sign Up | ||||
| Otsuka | RAXAR | grepafloxacin hydrochloride | TABLET;ORAL | 020695-001 | Nov 6, 1997 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-002 | Jun 7, 2006 | DISCN | Yes | No | 8,017,615*PED | ⤷ Sign Up | Y | ⤷ 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 | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-004 | Nov 13, 2017 | 8,580,796 | ⤷ Sign Up |
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-001 | Nov 13, 2017 | 7,053,092 | ⤷ Sign Up |
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-002 | Jun 7, 2006 | 9,387,182 | ⤷ Sign Up |
| Otsuka | RAXAR | grepafloxacin hydrochloride | TABLET;ORAL | 020695-001 | Nov 6, 1997 | 5,563,138 | ⤷ Sign Up |
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-006 | Nov 13, 2017 | 8,580,796 | ⤷ Sign Up |
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-002 | Nov 13, 2017 | 9,387,182 | ⤷ Sign Up |
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-004 | Nov 15, 2002 | 5,006,528*PED | ⤷ 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 | 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 |
| ➤ Subscribe | Tablets | 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg | ➤ Subscribe | 2006-11-15 |
International Patents for Otsuka Drugs
Supplementary Protection Certificates for Otsuka Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1675573 | PA2014020 | Lithuania | ⤷ Sign Up | PRODUCT NAME: ARIPIPRAZOLUM; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
| 1869025 | 2018C/037 | Belgium | ⤷ Sign Up | PRODUCT NAME: BREXPIPRAZOL OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730 |
| 2207786 | 301257 | Netherlands | ⤷ Sign Up | PRODUCT NAME: SAMENSTELLING WELKE OMVAT: CEDAZURIDINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; EN DECITABINE; REGISTRATION NO/DATE: EU/1/23/1756 20230918 |
| 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 |
| 0450097 | 09C0049 | France | ⤷ Sign Up | PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803 |
| 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 |
| 1869025 | C201830050 | Spain | ⤷ Sign Up | PRODUCT NAME: BREXPIPRAZOL O UNA SAL DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1294; DATE OF AUTHORISATION: 20180726; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1294; DATE OF FIRST AUTHORISATION IN EEA: 20180726 |
| >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.
