Details for New Drug Application (NDA): 206162
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NDA 206162 describes LYNPARZA, which is a drug marketed by Astrazeneca and is included in two NDAs. It is available from one supplier. There are twelve 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 206162
| Tradename: | LYNPARZA |
| Applicant: | Astrazeneca |
| Ingredient: | olaparib |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 206162
Generic Entry Date for 206162*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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.
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Dec 19, 2014 | TE: | RLD: | Yes | |||||
| Patent: | 8,143,241 | Patent Expiration: | Aug 12, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF BRCA MUTATED OVARIAN CANCER USING PARP INHIBITOR | ||||||||
| Patent: | 8,247,416 | Patent Expiration: | Sep 24, 2028 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | 8,859,562 | Patent Expiration: | Aug 4, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF BRCA MUTATED OVARIAN CANCER USING PARP INHIBITOR | ||||||||
Expired US Patents for NDA 206162
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca | LYNPARZA | olaparib | CAPSULE;ORAL | 206162-001 | Dec 19, 2014 | 7,151,102 | ⤷ Get Started Free |
| Astrazeneca | LYNPARZA | olaparib | CAPSULE;ORAL | 206162-001 | Dec 19, 2014 | 8,912,187 | ⤷ Get Started Free |
| Astrazeneca | LYNPARZA | olaparib | CAPSULE;ORAL | 206162-001 | Dec 19, 2014 | 7,981,889 | ⤷ Get Started Free |
| Astrazeneca | LYNPARZA | olaparib | CAPSULE;ORAL | 206162-001 | Dec 19, 2014 | 7,449,464 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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