Details for New Drug Application (NDA): 208558
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NDA 208558 describes LYNPARZA, which is a drug marketed by Astrazeneca and is included in two NDAs. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the LYNPARZA profile page.
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.
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.
Summary for 208558
| Tradename: | LYNPARZA |
| Applicant: | Astrazeneca |
| Ingredient: | olaparib |
| Patents: | 13 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208558
Generic Entry Date for 208558*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 208558
| Mechanism of Action | Poly(ADP-Ribose) Polymerase Inhibitors |
Suppliers and Packaging for NDA: 208558
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LYNPARZA | olaparib | TABLET;ORAL | 208558 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0668 | 0310-0668-12 | 120 TABLET, FILM COATED in 1 BOTTLE (0310-0668-12) |
| LYNPARZA | olaparib | TABLET;ORAL | 208558 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0668 | 0310-0668-60 | 60 TABLET, FILM COATED in 1 BOTTLE (0310-0668-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Aug 17, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 11, 2025 | ||||||||
| Regulatory Exclusivity Use: | FOR THE ADJUVANT TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA MUTATED HER2-NEGATIVE HIGH-RISK EARLY BREAST CANCER WHO HAVE PREVIOUSLY BEEN TREATED WITH NEOADJUVANT OR ADJUVANT CHEMOTHERAPY | ||||||||
| Regulatory Exclusivity Expiration: | May 31, 2026 | ||||||||
| Regulatory Exclusivity Use: | IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE FOR THE TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS BRCA-MUTATED (BRCAM) METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) | ||||||||
| Regulatory Exclusivity Expiration: | Aug 17, 2024 | ||||||||
| Regulatory Exclusivity Use: | MAINTENANCE TREATMENT OF ADULT PATIENTS WITH RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY | ||||||||
Expired US Patents for NDA 208558
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca | LYNPARZA | olaparib | TABLET;ORAL | 208558-001 | Aug 17, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| Astrazeneca | LYNPARZA | olaparib | TABLET;ORAL | 208558-001 | Aug 17, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| Astrazeneca | LYNPARZA | olaparib | TABLET;ORAL | 208558-002 | Aug 17, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| Astrazeneca | LYNPARZA | olaparib | TABLET;ORAL | 208558-001 | Aug 17, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| Astrazeneca | LYNPARZA | olaparib | TABLET;ORAL | 208558-002 | Aug 17, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| Astrazeneca | LYNPARZA | olaparib | TABLET;ORAL | 208558-001 | Aug 17, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| Astrazeneca | LYNPARZA | olaparib | TABLET;ORAL | 208558-002 | Aug 17, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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