Orgovyx is a drug owned by Sumitomo Pharma Switzerland Gmbh. It is protected by 9 US drug patents filed from 2021 to 2024. Out of these, 8 drug patents are active and 1 has expired. Orgovyx's patents have been open to challenges since 18 December, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 29, 2037. Details of Orgovyx's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US11795178 | Compositions of thienopyrimidine derivatives |
Sep, 2033
(8 years from now) | Active |
| US7300935 | Thienopyrimidine compounds and use thereof |
Jan, 2025
(a month from now) | Active |
| US8058280 | Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof |
Jan, 2025
(a month from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11583526 | Treatment of prostate cancer |
Sep, 2037
(12 years from now) | Active |
| US10449191 | Treatment of prostate cancer |
Sep, 2037
(12 years from now) | Active |
| US10786501 | Treatment of prostate cancer |
Sep, 2037
(12 years from now) | Active |
| US12097198 | Treatment of prostate cancer |
Sep, 2037
(12 years from now) | Active |
| US10350170 | Solid preparation |
Feb, 2036
(11 years from now) | Active |
| US8735401 | Thienopyrimidine compounds and use thereof |
Feb, 2024
(10 months ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Orgovyx's patents.
Latest Legal Activities on Orgovyx's Patents
Given below is the list of recent legal activities going on the following patents of Orgovyx.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification Critical | 09 Jul, 2024 | US10786501 |
| Patent eCofC Notification | 09 Jul, 2024 | US10786501 |
| Mail Patent eCofC Notification | 09 Jul, 2024 | US10786501 |
| Recordation of Patent eCertificate of Correction | 09 Jul, 2024 | US10786501 |
| Mail Certificate of Correction Memo | 02 Jul, 2024 | US10449191 |
| Mail Certificate of Correction Memo | 02 Jul, 2024 | US11583526 |
| Post Issue Communication - Certificate of Correction | 01 Jul, 2024 | US10449191 |
| Post Issue Communication - Certificate of Correction | 01 Jul, 2024 | US11583526 |
| Certificate of Correction Memo | 30 Jun, 2024 | US10449191 |
| Certificate of Correction Memo | 30 Jun, 2024 | US11583526 |
FDA has granted several exclusivities to Orgovyx. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Orgovyx, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Orgovyx.
Exclusivity Information
Orgovyx holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Orgovyx's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 18, 2025 |
Several oppositions have been filed on Orgovyx's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Orgovyx's generic, the next section provides detailed information on ongoing and past EP oppositions related to Orgovyx patents.
Orgovyx's Oppositions Filed in EPO
Orgovyx has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 15, 2022, by Sandoz Ag. This opposition was filed on patent number EP17823018A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP17823018A | Dec, 2022 | SANDOZ AG | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Orgovyx is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Orgovyx's family patents as well as insights into ongoing legal events on those patents.
Orgovyx's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Orgovyx's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 29, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Orgovyx Generics:
There are no approved generic versions for Orgovyx as of now.
Alternative Brands for Orgovyx
Orgovyx which is used for the treatment of advanced prostate cancer in adult patients, specifically when the cancer is sex-hormone-dependent., has several other brand drugs using the same active ingredient (Relugolix). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Sumitomo Pharma |
|
About Orgovyx
Orgovyx is a drug owned by Sumitomo Pharma Switzerland Gmbh. It is used for the treatment of advanced prostate cancer in adult patients, specifically when the cancer is sex-hormone-dependent. Orgovyx uses Relugolix as an active ingredient. Orgovyx was launched by Sumitomo Pharma in 2020.
Approval Date:
Orgovyx was approved by FDA for market use on 18 December, 2020.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Orgovyx is 18 December, 2020, its NCE-1 date is estimated to be 18 December, 2024.
Active Ingredient:
Orgovyx uses Relugolix as the active ingredient. Check out other Drugs and Companies using Relugolix ingredient
Treatment:
Orgovyx is used for the treatment of advanced prostate cancer in adult patients, specifically when the cancer is sex-hormone-dependent.
Dosage:
Orgovyx is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 120MG | TABLET | Prescription | ORAL |