Details for New Drug Application (NDA): 214621
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NDA 214621 describes ORGOVYX, which is a drug marketed by Sumitomo Pharma Am and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the ORGOVYX profile page.
The generic ingredient in ORGOVYX is relugolix. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the relugolix profile page.
The generic ingredient in ORGOVYX is relugolix. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the relugolix profile page.
Summary for 214621
| Tradename: | ORGOVYX |
| Applicant: | Sumitomo Pharma Am |
| Ingredient: | relugolix |
| Patents: | 12 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214621
Generic Entry Date for 214621*:
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: 214621
Suppliers and Packaging for NDA: 214621
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ORGOVYX | relugolix | TABLET;ORAL | 214621 | NDA | Sumitomo Pharma America, Inc. | 72974-120 | 72974-120-01 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-01) |
| ORGOVYX | relugolix | TABLET;ORAL | 214621 | NDA | Sumitomo Pharma America, Inc. | 72974-120 | 72974-120-95 | 16 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-95) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 120MG | ||||
| Approval Date: | Dec 18, 2020 | TE: | RLD: | Yes | |||||
| Patent: | 10,350,170 | Patent Expiration: | Feb 25, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 10,449,191 | Patent Expiration: | Sep 29, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER | ||||||||
| Patent: | 10,786,501 | Patent Expiration: | Sep 29, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER | ||||||||
Expired US Patents for NDA 214621
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sumitomo Pharma Am | ORGOVYX | relugolix | TABLET;ORAL | 214621-001 | Dec 18, 2020 | 8,058,280 | ⤷ Start Trial |
| Sumitomo Pharma Am | ORGOVYX | relugolix | TABLET;ORAL | 214621-001 | Dec 18, 2020 | 8,735,401 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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