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-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 | REXULTI | brexpiprazole | TABLET;ORAL | 205422-006 | Jul 10, 2015 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-003 | Nov 13, 2017 | RX | Yes | No | 9,320,455 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-004 | Nov 13, 2017 | RX | Yes | No | 8,545,402 | ⤷ 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 | aripiprazole | TABLET;ORAL | 021436-006 | Nov 15, 2002 | 4,734,416 | ⤷ Sign Up |
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-002 | Jun 7, 2006 | 8,642,760*PED | ⤷ Sign Up |
| Otsuka | ABILIFY | aripiprazole | TABLET;ORAL | 021436-002 | Nov 15, 2002 | 7,053,092 | ⤷ 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 | 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 |
| ➤ Subscribe | Tablets | 15 mg and 30 mg | ➤ Subscribe | 2013-09-23 |
International Patents for OTSUKA Drugs
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 |
| 2207786 | CR 2023 00037 | Denmark | ⤷ Sign Up | PRODUCT NAME: CEDAZURIDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1756 20230918 |
| 2207786 | LUC00327 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND 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.
