ORGOVYX Drug Patent Profile
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When do Orgovyx patents expire, and when can generic versions of Orgovyx launch?
Orgovyx is a drug marketed by Sumitomo Pharma and is included in one NDA. There are eight patents protecting this drug.
This drug has one hundred and fifty-nine patent family members in thirty-six countries.
The generic ingredient in ORGOVYX is relugolix. One supplier is listed for this compound. 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: | 159 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 54 |
Clinical Trials: | 6 |
Patent Applications: | 121 |
Drug Prices: | Drug price information for ORGOVYX |
What excipients (inactive ingredients) are in ORGOVYX? | ORGOVYX excipients list |
DailyMed Link: | ORGOVYX at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.
Recent Clinical Trials for ORGOVYX
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Pfizer | Phase 2 |
Dana-Farber Cancer Institute | Phase 2 |
Myovant Sciences GmbH | Phase 2 |
Pharmacology for ORGOVYX
Anatomical Therapeutic Chemical (ATC) Classes for ORGOVYX
US Patents and Regulatory Information for ORGOVYX
ORGOVYX is protected by eight US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ORGOVYX is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting ORGOVYX
Solid preparation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Treatment of prostate cancer
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER
Treatment of prostate cancer
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Thienopyrimidine compounds and use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Thienopyrimidine compounds and use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER THAT IS SEX-HORMONE-DEPENDENT
FDA Regulatory Exclusivity protecting ORGOVYX
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sumitomo Pharma | ORGOVYX | relugolix | TABLET;ORAL | 214621-001 | Dec 18, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sumitomo Pharma | ORGOVYX | relugolix | TABLET;ORAL | 214621-001 | Dec 18, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Sumitomo Pharma | ORGOVYX | relugolix | TABLET;ORAL | 214621-001 | Dec 18, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ORGOVYX
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sumitomo Pharma | ORGOVYX | relugolix | TABLET;ORAL | 214621-001 | Dec 18, 2020 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ORGOVYX
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Accord Healthcare S.L.U. | Orgovyx | relugolix | EMEA/H/C/005353 Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer. |
Authorised | no | no | no | 2022-04-29 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ORGOVYX
When does loss-of-exclusivity occur for ORGOVYX?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 16224503
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2017018173
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 78223
Estimated Expiration: ⤷ Try a Trial
China
Patent: 7249590
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0230613
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 26118
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 63110
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 63110
Estimated Expiration: ⤷ Try a Trial
Patent: 33847
Estimated Expiration: ⤷ Try a Trial
Finland
Patent: 63110
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 62269
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 4132
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 2016136849
Estimated Expiration: ⤷ Try a Trial
Patent: 30978
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 63110
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 0680
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 17010945
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 5026
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 63110
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 63110
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 377
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 63110
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 50995
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 44224
Estimated Expiration: ⤷ Try a Trial
Patent: 1639575
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ORGOVYX around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 7043503 | ⤷ Try a Trial | |
China | 107249590 | 固体制剂 (Solid preparation) | ⤷ Try a Trial |
European Patent Office | 2900675 | PROCÉDÉ DE PRODUCTION D'UN DÉRIVÉ DE THIÉNOPYRIMIDINE (PRODUCTION METHOD OF THIENOPYRIMIDINE DERIVATIVE) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ORGOVYX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1591446 | 51/2021 | Austria | ⤷ Try a Trial | PRODUCT NAME: RELUGOLIX ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1565 (MITTEILUNG) 20210720 |
1591446 | 2022C/501 | Belgium | ⤷ Try a Trial | PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1565 20210720 |
1591446 | C 2021 047 | Romania | ⤷ Try a Trial | PRODUCT NAME: RELUGOLIX SAU O SARE A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/21/1565; DATE OF NATIONAL AUTHORISATION: 20210716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1565; DATE OF FIRST AUTHORISATION IN EEA: 20210716 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |