DrugPatentWatch Database Preview
LYNPARZA Drug Profile
Email this page to a colleague
See Plans and PricingWhich patents cover Lynparza, and when can generic versions of Lynparza launch?
Lynparza is a drug marketed by Astrazeneca Pharms and is included in two NDAs. There are eight patents protecting this drug.
This drug has two hundred and seventy-eight patent family members in forty-nine 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 19, 2025. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for LYNPARZA
| International Patents: | 278 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 117 |
| Clinical Trials: | 78 |
| Patent Applications: | 199 |
| 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 TREATMENT OF ADULTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY 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 |
|---|---|
| Centre Georges Francois Leclerc | Phase 2 |
| Thomas Jefferson University | Phase 1 |
| Hospices Civils de Lyon | Phase 2 |
Pharmacology for LYNPARZA
| Drug Class | Poly(ADP-Ribose) Polymerase Inhibitor |
| Mechanism of Action | Poly(ADP-Ribose) Polymerase Inhibitors |
Synonyms for LYNPARZA
| (2H)-Phthalazinone, 4-((3-((4-(cyclopropylcarbonyl)-1-piperazinyl)carbonyl)-4-fluorophenyl)methyl)- |
| 09L |
| 1-(cyclopropylcarbonyl)-4-[5-[(3,4-dihydro-4-oxo-1 |
| 1-(Cyclopropylcarbonyl)-4-[5-[(3,4-dihydro-4-oxo-1-phthalazinyl)methyl]-2-fluorobenzoyl]piperazine |
| 1(2H)-Phthalazinone, 4-[[3-[[4-(cyclopropylcarbonyl)-1-piperazinyl]carbonyl]-4-fluorophenyl]methyl]- |
| 1021843-02-6 |
| 4-((3-{(4-(cyclopropylcarbonyl)piperazin-1-yl)carbonyl}-4-fluorophenyl)methyl)phthalazin-1(2H)-one |
| 4-({3-[(4-cyclopropanecarbonylpiperazin-1-yl)carbonyl]-4-fluorophenyl}methyl)-1,2-dihydrophthalazin-1-one |
| 4-(3-(4-(Cyclopropanecarbonyl)piperazine-1-carbonyl)-4-fluorobenzyl)phthalazin-1(2H)-one |
| 4-(3-{[4-(Cyclopropylcarbonyl)piperazin-1-Yl]carbonyl}-4-Fluorobenzyl)phthalazin-1(2h)-One |
| 4-[(3-{[4-(Cyclopropylcarbonyl)piperazin-1-yl]carbonyl}-4-fluorophenyl)methyl]phthalazin-1(2H)-one |
| 4-[(3-{[4-Cyclopropylcarbonyl)piperazin-4-yl]carbonyl}-4-fluorophenyl)methyl]phtalazin-1(2H)-one |
| 4-[[3-[4-(cyclopropanecarbonyl)piperazine-1-carbonyl]-4-fluoro-phenyl]methyl]-2H-phthalazin-1-one |
| 4-[[3-[4-(Cyclopropanecarbonyl)piperazine-1-carbonyl]-4-fluorophenyl]methyl]-2H-phthalazin-1-one |
| 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one |
| 4-[3-[4-(Cyclopropanecarbonyl)piperazine-1-carbonyl]-4-fluorobenzyl]phthalazin-1(2H)-one |
| 4-{[3-(4-cyclopropanecarbonylpiperazine-1-carbonyl)-4-fluorophenyl]methyl}-1,2-dihydrophthalazin-1-one |
| 4-{[3-(4-cyclopropanecarbonylpiperazine-1-carbonyl)-4-fluorophenyl]methyl}-2H-phthalazin-1-one |
| 4CA-0938 |
| 763113-22-0 |
| 894104-70-2 |
| 937799-91-2 |
| A9666 |
| AB0009952 |
| AB1009702 |
| ABP000423 |
| AC-7939 |
| ACN-032229 |
| Acylpiperazine analogue, 47 |
| AJ-101717 |
| AKOS005145764 |
| AN-493 |
| AN-5279 |
| ANW-43329 |
| AOB1085 |
| API0024518 |
| AX8162101 |
| AZ2281 |
| AZD 2281 |
| AZD 2281|||KU 0059436|||KU 59436 |
| AZD-2281 |
| AZD-2281 (Olaparib) |
| AZD2281 |
| AZD2281,Olaparib, KU-0059436 |
| AZD2281(olaparib) |
| AZD2281(olaparib)/AZD-2281/KU0059436 |
| BB 0260909 |
| BC245405 |
| BCP01872 |
| BCP9000363 |
| BCPP000360 |
| BDBM27566 |
| BR-40514 |
| BRD-K02113016-001-08-9 |
| BRD-K02113016-001-09-7 |
| cc-16 |
| CHEBI:83766 |
| CHEMBL521686 |
| CS-0075 |
| CTK8B3857 |
| D09730 |
| DB09074 |
| EN002690 |
| EX-7210 |
| EX-A002 |
| FDLYAMZZIXQODN-UHFFFAOYSA-N |
| FT-0083489 |
| FT-0651458 |
| GP0126 |
| GTPL7519 |
| HMS3654G13 |
| HY-10162 |
| I06-2362 |
| J-503540 |
| KS-00000HXY |
| KU-0059436 |
| KU-59436 |
| KU0059436 |
| KU59436 |
| Lynparza (TN) |
| MFCD13185161 |
| MFCD13185161 (95%) |
| MLS006010185 |
| MolPort-009-679-395 |
| NCGC00238451-01 |
| NCGC00238451-02 |
| NCGC00238451-09 |
| NSC-747856 |
| NSC747856 |
| Olaparib |
| Olaparib - AZD2281 |
| Olaparib (AZD2281, Ku-0059436) |
| Olaparib (AZD2281, KU0059436) |
| Olaparib (AZD2281) |
| Olaparib (JAN/USAN/INN) |
| Olaparib [USAN:INN] |
| OLAPARIB cpd |
| Olaparib; KU 0059436 |
| Olaparibum |
| PubChem19148 |
| QC-2660 |
| RL04905 |
| S-3781 |
| S-7836 |
| s1060 |
| SB14617 |
| SC-65060 |
| SCHEMBL426568 |
| SMR004701291 |
| SS-4573 |
| SW218142-2 |
| SY040527 |
| UNII-WOH1JD9AR8 |
| WOH1JD9AR8 |
| Z-3275 |
| ZINC40430143 |
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 | 208558-002 | Aug 17, 2017 | RX | Yes | Yes | 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 | 208558-001 | Aug 17, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| 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 | 208558-001 | Aug 17, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Astrazeneca Pharms | LYNPARZA | olaparib | CAPSULE;ORAL | 206162-001 | Dec 19, 2014 | 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 |
|---|---|---|
| Slovenia | 1633724 | Start Trial |
| Hong Kong | 1203959 | Start Trial |
| United Kingdom | 0305681 | Start Trial |
| Russian Federation | 2010149166 | Start Trial |
| Ukraine | 94209 | Start Trial |
| New Zealand | 542680 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for LYNPARZA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1633724 | 13/2015 | Austria | Start Trial | PRODUCT NAME: OLAPARIB UND SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959 20141216 |
| 1633724 | PA2015016 | Lithuania | Start Trial | PRODUCT NAME: OLAPARIBUM; REGISTRATION NO/DATE: EU/1/14/959 20141216 |
| 1633724 | 92680 | Luxembourg | Start Trial | PRODUCT NAME: OLAPARIB AINSI QUE DES SELS ET DES SOLVATES DE CELUI-CI. FIRST REGISTRATION: 20141218 |
| 1633724 | 122015000025 | Germany | Start Trial | PRODUCT NAME: OLAPARIB, SOWIE SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959/001 20141216 |
| 1633724 | C01633724/01 | Switzerland | Start Trial | PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: SWISSMEDIC 65160 14.01.2016 |
| 2346495 | PA2018014 | Lithuania | Start Trial | PRODUCT NAME: AMORFINIS OLAPARIBAS ARBA JO DRUSKA ARBA SOLVATAS KIETOJE DISPERSIJOJE; REGISTRATION NO/DATE: EU/1/14/959 20180508 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
