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-eight US patents protecting OTSUKA drugs.
There are one thousand and thirty patent family members on OTSUKA drugs in fifty-four countries and forty-nine supplementary protection certificates in sixteen countries.
Summary for Otsuka
| International Patents: | 1030 |
| US Patents: | 58 |
| 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 | 8,399,469 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-001 | Feb 28, 2013 | RX | Yes | No | 8,338,427 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-004 | Nov 13, 2017 | RX | Yes | No | 9,444,503 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-004 | Nov 15, 2002 | AB | RX | Yes | No | 8,017,615*PED | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-001 | Feb 28, 2013 | RX | Yes | No | 11,648,347 | ⤷ 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 | JYNARQUE | tolvaptan | TABLET;ORAL | 204441-003 | Apr 23, 2018 | 5,753,677 | ⤷ Sign Up |
| Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-001 | May 19, 2009 | 5,258,510 | ⤷ Sign Up |
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-004 | Nov 15, 2002 | 9,089,567 | ⤷ Sign Up |
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-003 | Nov 13, 2017 | 8,017,615 | ⤷ Sign Up |
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-002 | Feb 28, 2013 | 9,089,567 | ⤷ 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
Supplementary Protection Certificates for Otsuka Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0367141 | SPC/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 |
| 1869025 | 32/2018 | Austria | ⤷ Sign Up | PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 (MITTEILUNG) 20180727 |
| 2207786 | 2023C/551 | Belgium | ⤷ Sign Up | PRODUCT NAME: UNE COMPOSITION COMPRENANT : DE LA CEDAZURIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ; ET LA DECITABINE; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918 |
| 1675573 | C20140014 00322 | Estonia | ⤷ Sign Up | PRODUCT NAME: ARIPIPRASOOL;REG NO/DATE: K(2013)8163 (LOPLIK) 19.11.2013 |
| 1675573 | CA 2014 00026 | Denmark | ⤷ Sign Up | PRODUCT NAME: ARIPIPRAZOL; REG. NO/DATE: EU/1/13/882/001-004 20131119 |
| >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.
