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 sixty-one US patents protecting OTSUKA drugs.
There are one thousand and six patent family members on OTSUKA drugs in fifty-three countries and thirty-six supplementary protection certificates in sixteen countries.
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 | 202971-001 | Feb 28, 2013 | RX | Yes | No | 10,980,803 | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-002 | Nov 13, 2017 | RX | Yes | Yes | 9,444,503 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Otsuka | ABILIFY MYCITE KIT | aripiprazole | TABLET;ORAL | 207202-006 | Nov 13, 2017 | RX | Yes | No | 9,119,554 | ⤷ 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 ASIMTUFII | aripiprazole | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 217006-002 | Apr 27, 2023 | 8,338,428 | ⤷ Try a Trial |
Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-005 | Jun 7, 2006 | 5,006,528*PED | ⤷ 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 | 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 |
➤ Subscribe | Injection | 6 mg/mL | ➤ Subscribe | 2012-12-26 |
International Patents for OTSUKA Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
European Patent Office | 3205265 | ⤷ Try a Trial |
Hungary | 0600141 | ⤷ Try a Trial |
Germany | 60327225 | ⤷ 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 |
---|---|---|---|---|
1675573 | 122014000057 | Germany | ⤷ Try a Trial | PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 20131115 |
1869025 | 122018000088 | Germany | ⤷ Try a Trial | PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 20180726 |
0451216 | 99C0028 | Belgium | ⤷ Try a Trial | PRODUCT NAME: GREPAFLOXACINE; CHLORHYDRATE SESQUIHYDRATE; NAT. REGISTRATION NO/DATE: NL 23 373 19990525; FIRST REGISTRATION: DE - 4062.00.00 19970731 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.