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Olaparib - Generic Drug Details
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What are the generic drug sources for olaparib and what is the scope of patent protection?
Olaparib
is the generic ingredient in one branded drug marketed by Astrazeneca Pharms and is included in two NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Olaparib has two hundred and eighty patent family members in fifty countries.
There are three drug master file entries for olaparib. One supplier is listed for this compound.
Summary for olaparib
International Patents: | 280 |
US Patents: | 11 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Drug Master File Entries: | 3 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 121 |
Clinical Trials: | 285 |
Patent Applications: | 1,421 |
What excipients (inactive ingredients) are in olaparib? | olaparib excipients list |
DailyMed Link: | olaparib at DailyMed |
Recent Clinical Trials for olaparib
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
AGO Research GmbH | Phase 2 |
North Eastern German Society of Gynaecological Oncology | Phase 2 |
Arbeitsgemeinschaft Gynaekologische Onkologie Austria | Phase 2 |
Pharmacology for olaparib
Drug Class | Poly(ADP-Ribose) Polymerase Inhibitor |
Mechanism of Action | Poly(ADP-Ribose) Polymerase Inhibitors |
US Patents and Regulatory Information for olaparib
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca Pharms | LYNPARZA | olaparib | TABLET;ORAL | 208558-001 | Aug 17, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Astrazeneca Pharms | LYNPARZA | olaparib | TABLET;ORAL | 208558-001 | Aug 17, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
Astrazeneca Pharms | LYNPARZA | olaparib | TABLET;ORAL | 208558-002 | Aug 17, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Astrazeneca Pharms | LYNPARZA | olaparib | TABLET;ORAL | 208558-002 | Aug 17, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Astrazeneca Pharms | LYNPARZA | olaparib | TABLET;ORAL | 208558-002 | Aug 17, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Astrazeneca Pharms | LYNPARZA | olaparib | TABLET;ORAL | 208558-002 | Aug 17, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Astrazeneca Pharms | LYNPARZA | olaparib | CAPSULE;ORAL | 206162-001 | Dec 19, 2014 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for olaparib
Country | Patent Number | Estimated Expiration |
---|---|---|
Poland | 1660095 | Start Trial |
Ukraine | 97494 | Start Trial |
Costa Rica | 20110186 | Start Trial |
Japan | 5607773 | Start Trial |
Cyprus | 1110335 | Start Trial |
Norway | 341963 | Start Trial |
Norway | 20063078 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for olaparib
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2346495 | 122018000124 | Germany | Start Trial | PRODUCT NAME: AMORPHES OLAPARIB, ODER EIN SALZ ODER SOLVAT DAVON, IN EINER FESTEN DISPERSION; REGISTRATION NO/DATE: EU/1/14/959/002-005 20180508 |
1633724 | 2015/016 | Ireland | Start Trial | PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216 |
1633724 | C300726 | Netherlands | Start Trial | PRODUCT NAME: OLAPARIB, EN ZOUTEN EN; REGISTRATION NO/DATE: EU/1/14/959/001 20141216 |
1633724 | S1500012 | Hungary | Start Trial | PRODUCT NAME: OLAPARIB |
1633724 | 122015000025 | Germany | Start Trial | PRODUCT NAME: OLAPARIB, SOWIE SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959/001 20141216 |
1633724 | C 2015 011 | Romania | Start Trial | PRODUCT NAME: OLAPARIB; NATIONAL AUTHORISATION NUMBER: EU/1/14/959/001; DATE OF NATIONAL AUTHORISATION: 20141216; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/959/001; DATE OF FIRST AUTHORISATION IN EEA: 20141216 |
2346495 | CA 2018 00039 | Denmark | Start Trial | PRODUCT NAME: AMORF OLAPARIB ELLER ET SALT ELLER SOLVAT DERAF, I EN FAST DISPERSION; REG. NO/DATE: EU/1/14/959 20180515 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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