Orgovyx Patent Expiration

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 will be open to challenges from 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
US8058280 Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof
Jan, 2025

(3 months from now)

Active
US7300935 Thienopyrimidine compounds and use thereof
Jan, 2025

(3 months 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
US12097198 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
US10350170 Solid preparation
Feb, 2036

(11 years from now)

Active
US8735401 Thienopyrimidine compounds and use thereof
Feb, 2024

(8 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.

Given below is the list of recent legal activities going on the following patents of Orgovyx.

Activity Date Patent Number
Patent litigations
Email Notification 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

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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
Patent litigations
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

Orgovyx has patent protection in a total of 34 countries. It's US patent count contributes only to 20.2% of its total global patent coverage. Click below to unlock the full patent family tree for Orgovyx.

Family Patents

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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
Myfembree






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