Orilissa Patent Expiration

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

(3 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

(5 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.

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

Activity Date Patent Number
Patent litigations
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 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

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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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

Orilissa has patent protection in a total of 24 countries. It's US patent count contributes only to 35.9% of its total global patent coverage. Click below to unlock the full patent family tree for Orilissa.

Family Patents

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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
Myfembree Used for managing heavy menstrual bleeding and pain associated with uterine fibroids in premenopausal women, as well as pain associated with endometriosis.

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
Oriahnn (copackaged)






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