By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
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ORGOVYX Drug Profile
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When do Orgovyx patents expire, and when can generic versions of Orgovyx launch?
Orgovyx is a drug marketed by Myovant Sciences and is included in one NDA. There are six patents protecting this drug.
This drug has seventy-two patent family members in twenty-five countries.
The generic ingredient in ORGOVYX is relugolix. Additional details are available on the relugolix profile page.
DrugPatentWatch® Generic Entry Outlook for Orgovyx
Orgovyx will be eligible for patent challenges on December 18, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 25, 2036. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for ORGOVYX
| International Patents: | 72 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| What excipients (inactive ingredients) are in ORGOVYX? | ORGOVYX excipients list |
| DailyMed Link: | ORGOVYX at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for ORGOVYX
Generic Entry Date for ORGOVYX*:
Constraining patent/regulatory exclusivity:
NDA:
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.
US Patents and Regulatory Information for ORGOVYX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Myovant Sciences | ORGOVYX | relugolix | TABLET;ORAL | 214621-001 | Dec 18, 2020 | RX | Yes | Yes | Get Started Free | Get Started Free | Get Started Free | ||||
| Myovant Sciences | ORGOVYX | relugolix | TABLET;ORAL | 214621-001 | Dec 18, 2020 | RX | Yes | Yes | Get Started Free | Get Started Free | Get Started Free | ||||
| Myovant Sciences | ORGOVYX | relugolix | TABLET;ORAL | 214621-001 | Dec 18, 2020 | RX | Yes | Yes | Get Started Free | Get Started Free | Y | Get Started Free | |||
| Myovant Sciences | ORGOVYX | relugolix | TABLET;ORAL | 214621-001 | Dec 18, 2020 | RX | Yes | Yes | Get Started Free | Get Started Free | Get Started Free | ||||
| >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 ORGOVYX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Colombia | 5590921 | Get Started Free |
| Argentina | 110636 | Get Started Free |
| Mexico | 2019003733 | Get Started Free |
| Australia | 2017336338 | Get Started Free |
| >Country | >Patent Number | >Estimated Expiration |
