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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 freedom to operate?
Olaparib
is the generic ingredient in one branded drug marketed by Astrazeneca Pharms and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Olaparib has two hundred and seventy-eight patent family members in forty-nine countries.
There are three drug master file entries for olaparib. One supplier is listed for this compound.
Summary for olaparib
| International Patents: | 278 |
| US Patents: | 8 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 3 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 117 |
| Clinical Trials: | 230 |
| Patent Applications: | 380 |
| DailyMed Link: | olaparib at DailyMed |
Recent Clinical Trials for olaparib
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Merck Sharp & Dohme Corp. | Phase 2/Phase 3 |
| Yale University | Phase 2 |
| Centre Georges Francois Leclerc | Phase 2 |
Pharmacology for olaparib
| Drug Class | Poly(ADP-Ribose) Polymerase Inhibitor |
| Mechanism of Action | Poly(ADP-Ribose) Polymerase Inhibitors |
Synonyms for olaparib
| (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 |
| Lynparza (TN) |
| MFCD13185161 |
| MFCD13185161 (95%) |
| MLS006010185 |
| MolPort-009-679-395 |
| NCGC00238451-01 |
| NCGC00238451-02 |
| NCGC00238451-09 |
| NSC-747856 |
| NSC747856 |
| 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 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 | 208558-002 | 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 | 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 | CAPSULE;ORAL | 206162-001 | Dec 19, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 olaparib
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2012087135 | Start Trial |
| Hong Kong | 1203959 | Start Trial |
| Israel | 197420 | Start Trial |
| Norway | 20031498 | Start Trial |
| Hungary | 228960 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for olaparib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1633724 | 122015000025 | Germany | Start Trial | PRODUCT NAME: OLAPARIB, SOWIE SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959/001 20141216 |
| 1633724 | 92680 | Luxembourg | Start Trial | PRODUCT NAME: OLAPARIB AINSI QUE DES SELS ET DES SOLVATES DE CELUI-CI. FIRST REGISTRATION: 20141218 |
| 1633724 | CR 2015 00012 | Denmark | Start Trial | PRODUCT NAME: OLAPARIB, OG SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/14/959/001 20141216 |
| 1633724 | 15C0022 | France | Start Trial | PRODUCT NAME: OLAPARIB,SELS ET SOLVATES DE CELUI-CI; REGISTRATION NO/DATE: EU 1/14/959 20141218 |
| 1633724 | C01633724/01 | Switzerland | Start Trial | PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: SWISSMEDIC 65160 14.01.2016 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.