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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.
Generic Entry Opportunity Date for 206162
*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.
Pharmacology for NDA: 206162
|Mechanism of Action||Poly(ADP-Ribose) Polymerase Inhibitors |
Profile for product number 001
|Approval Date:||Dec 19, 2014||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Dec 19, 2019|
|Regulatory Exclusivity Use:||NEW CHEMICAL ENTITY|
|Regulatory Exclusivity Expiration:||Dec 19, 2021|
|Regulatory Exclusivity Use:||USE OF AS MONOTHERAPY FOR PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA MUTATED (AS DETECTED BY AN FDA-APPROVED TEST) ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH THREE OR MORE PRIOR LINES OF CHEMOTHERAPY|
|Patent:||Start Trial||Patent Expiration:||Apr 29, 2022||Product Flag?||Y||Substance Flag?||Y||Delist Request?|
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