JANSSEN BIOTECH Company Profile
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What is the competitive landscape for JANSSEN BIOTECH, and when can generic versions of JANSSEN BIOTECH drugs launch?
JANSSEN BIOTECH has five approved drugs.
There are thirty-five US patents protecting JANSSEN BIOTECH drugs.
There are eight hundred and thirty-three patent family members on JANSSEN BIOTECH drugs in sixty-one countries and seventy-three supplementary protection certificates in twenty countries.
Summary for JANSSEN BIOTECH
| International Patents: | 833 |
| US Patents: | 35 |
| Tradenames: | 5 |
| Ingredients: | 5 |
| NDAs: | 5 |
Drugs and US Patents for JANSSEN BIOTECH
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Biotech | AKEEGA | abiraterone acetate; niraparib tosylate | TABLET;ORAL | 216793-002 | Aug 11, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | |||||
| Janssen Biotech | BALVERSA | erdafitinib | TABLET;ORAL | 212018-003 | Apr 12, 2019 | RX | Yes | Yes | 8,895,601 | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Janssen Biotech | BALVERSA | erdafitinib | TABLET;ORAL | 212018-001 | Apr 12, 2019 | RX | Yes | No | 9,464,071 | ⤷ Sign Up | ⤷ Sign Up | ||||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-002 | Feb 17, 2023 | RX | Yes | Yes | 9,388,159 | ⤷ Sign Up | Y | 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 JANSSEN BIOTECH
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Biotech | ZYTIGA | abiraterone acetate | TABLET;ORAL | 202379-001 | Apr 28, 2011 | 5,604,213 | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for JANSSEN BIOTECH drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 500 mg | ➤ Subscribe | 2017-08-23 |
| ➤ Subscribe | Tablets | 250 mg | ➤ Subscribe | 2015-04-28 |
International Patents for JANSSEN BIOTECH Drugs
Supplementary Protection Certificates for JANSSEN BIOTECH Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2368550 | PA2019512,C2368550 | Lithuania | ⤷ Sign Up | PRODUCT NAME: APALUTAMIDAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1342 20190114 |
| 2109608 | 1890020-9 | Sweden | ⤷ Sign Up | PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARY THE TOSYLATE OR A HYDRATE, ESPECIALLY THE TOSYLATE MONOHYDRATE; REG. NO/DATE: EU/1/17/1235 20171120 |
| 2240466 | C201830027 | Spain | ⤷ Sign Up | PRODUCT NAME: NIRAPARIB; NATIONAL AUTHORISATION NUMBER: EU/1/17/1235; DATE OF AUTHORISATION: 20171116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1235; DATE OF FIRST AUTHORISATION IN EEA: 20171116 |
| 2368550 | 2019C/529 | Belgium | ⤷ Sign Up | PRODUCT NAME: APALUTAMIDE OU UN SEL PHARMACOLOGIQUEMENT ADMISSIBLE DE CELLES-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1342 20190116 |
| >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.
