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LYNPARZA Drug Profile
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Which patents cover Lynparza, and what generic alternatives are available?
Lynparza is a drug marketed by Astrazeneca Pharms and is included in two NDAs. There are eleven patents protecting this drug.
This drug has two hundred and seventy-nine patent family members in fifty countries.
The generic ingredient in LYNPARZA is olaparib. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the olaparib profile page.
US ANDA Litigation and Generic Entry Outlook for Lynparza
Lynparza was eligible for patent challenges on December 19, 2018.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 27, 2026. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for LYNPARZA
| International Patents: | 279 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 118 |
| Clinical Trials: | 84 |
| Patent Applications: | 203 |
| Drug Prices: | Drug price information for LYNPARZA |
| DailyMed Link: | LYNPARZA at DailyMed |
Generic Entry Opportunity Date for LYNPARZA
Generic Entry Dates for LYNPARZA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL |
Generic Entry Dates for LYNPARZA*:
Constraining patent/regulatory exclusivity:
MAINTENANCE TX OF ADULTS W/ DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DZ HAS NOT PROGRESSED ON >=16WKS OF 1ST LINE PLATINUM BASED CHEMO REGIMEN. SELECT PTS FOR THERAPY BASED ON APPROVED COMPANION DIAGNOSTIC NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for LYNPARZA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Osteosarcoma Institute | Phase 2 |
| Dana-Farber Cancer Institute | Phase 2 |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Phase 2 |
Pharmacology for LYNPARZA
| Drug Class | Poly(ADP-Ribose) Polymerase Inhibitor |
| Mechanism of Action | Poly(ADP-Ribose) Polymerase Inhibitors |
US Patents and Regulatory Information for LYNPARZA
| 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 | 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 | 208558-001 | 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 | ||||
| >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 LYNPARZA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Norway | 20054625 | Start Trial |
| Hong Kong | 1158528 | Start Trial |
| Russian Federation | 2010149166 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2005053662 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for LYNPARZA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1633724 | 596 | Finland | Start Trial | |
| 2346495 | 300956 | Netherlands | Start Trial | PRODUCT NAME: AMORF OLAPARIB OF EEN ZOUT OF SOLVAAT DAARVAN, IN EEN VASTE DISPERSIE; REGISTRATION NO/DATE: EU1/14/959 20180515 |
| 1633724 | PA2015016 | Lithuania | Start Trial | PRODUCT NAME: OLAPARIBUM; REGISTRATION NO/DATE: EU/1/14/959 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
