Orilissa is a drug owned by Abbvie Inc. It is protected by 14 US drug patents filed from 2018 to 2024. Out of these, 9 drug patents are active and 5 have expired. Orilissa's patents have been open to challenges since 23 July, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 27, 2040. Details of Orilissa'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. | |||
| US11542239 | Elagolix sodium compositions and processes |
Jul, 2039
(14 years from now) | Active |
| US7419983 | Gonadotropin-releasing hormone receptor antagonists and methods related thereto |
Jul, 2029
(4 years from now) | Active |
| US7056927 | Gonadotropin-releasing hormone receptor antagonists and methods relating thereto |
Sep, 2024
(2 months ago) |
Expired
|
| US7462625 | Gonadotropin-releasing hormone receptor antagonists and methods relating thereto |
Jan, 2021
(3 years ago) |
Expired
|
| US6872728 | Gonadotropin-releasing hormone receptor antagonists and methods relating thereto |
Jan, 2021
(3 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11690845 | Methods of administering elagolix |
Aug, 2040
(15 years from now) | Active |
| US12102637 | Pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis |
Aug, 2038
(13 years from now) | Active |
| US11690854 | Methods of treating heavy menstrual bleeding |
Apr, 2038
(13 years from now) | Active |
| US10682351 | Methods of administering elagolix |
Sep, 2036
(11 years from now) | Active |
| US10537572 | Methods of administering elagolix |
Sep, 2036
(11 years from now) | Active |
| US11344551 | Methods of treating heavy menstrual bleeding |
Mar, 2034
(9 years from now) | Active |
| US11707464 | Methods of treating heavy menstrual bleeding |
Mar, 2034
(9 years from now) | Active |
| US7176211 | Gonadotropin-releasing hormone receptor antagonists and methods relating thereto |
Jul, 2024
(4 months ago) |
Expired
|
| US7179815 | Gonadotropin-releasing hormone receptor antagonists and methods relating thereto |
Mar, 2021
(3 years 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 Orilissa's patents.
Latest Legal Activities on Orilissa's Patents
Given below is the list of recent legal activities going on the following patents of Orilissa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Post Issue Communication - Certificate of Correction | 08 Jul, 2024 | US11542239 |
| Mail Certificate of Correction Memo | 05 Jul, 2024 | US11542239 |
| Certificate of Correction Memo | 02 Jul, 2024 | US11542239 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 Nov, 2023 | US10682351 |
| Mail Certificate of Correction Memo | 14 Sep, 2023 | US11542239 |
| Post Issue Communication - Certificate of Correction | 12 Sep, 2023 | US11542239 |
| Certificate of Correction Memo | 11 Sep, 2023 | US11542239 |
| Electronic Review Critical | 10 Aug, 2023 | US11690845 |
| Post Issue Communication - Certificate of Correction | 09 Aug, 2023 | US11690845 |
| Mail Certificate of Correction Memo | 09 Aug, 2023 | US11690845 |
FDA has granted several exclusivities to Orilissa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Orilissa, 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 Orilissa.
Exclusivity Information
Orilissa holds 1 exclusivities. All of its exclusivities have expired in 2023. Details of Orilissa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 23, 2023 |
US patents provide insights into the exclusivity only within the United States, but Orilissa 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 Orilissa's family patents as well as insights into ongoing legal events on those patents.
Orilissa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Orilissa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 27, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Orilissa Generics:
There are no approved generic versions for Orilissa as of now.
How can I launch a generic of Orilissa before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Orilissa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Orilissa's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Orilissa -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 150 mg and 200 mg | 25 Jul, 2022 | 9 | 01 Sep, 2036 |
Alternative Brands for Orilissa
Orilissa which is used for managing moderate to severe pain associated with endometriosis., has several other brand drugs in the same treatment category and using the same active ingredient (Elagolix Sodium). 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 | Treatment Area | ||
|---|---|---|---|---|
| Sumitomo Pharma |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Elagolix Sodium. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Abbvie |
|
About Orilissa
Orilissa is a drug owned by Abbvie Inc. It is used for managing moderate to severe pain associated with endometriosis. Orilissa uses Elagolix Sodium as an active ingredient. Orilissa was launched by Abbvie in 2018.
Approval Date:
Orilissa was approved by FDA for market use on 23 July, 2018.
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 Orilissa is 23 July, 2018, its NCE-1 date is estimated to be 23 July, 2022.
Active Ingredient:
Orilissa uses Elagolix Sodium as the active ingredient. Check out other Drugs and Companies using Elagolix Sodium ingredient
Treatment:
Orilissa is used for managing moderate to severe pain associated with endometriosis.
Dosage:
Orilissa is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 200MG BASE | TABLET | Prescription | ORAL |
| EQ 150MG BASE | TABLET | Prescription | ORAL |