Oriahnn (copackaged) is a drug owned by Abbvie Inc. It is protected by 11 US drug patents filed from 2020 to 2024. Out of these, 7 drug patents are active and 4 have expired. Oriahnn (Copackaged)'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 Oriahnn (copackaged)'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
|
| US6872728 | Gonadotropin-releasing hormone receptor antagonists and methods relating thereto |
Jan, 2021
(3 years ago) |
Expired
|
| US7462625 | 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 |
| US12083227 | Solid pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis |
Aug, 2038
(13 years from now) | Active |
| US10881659 | Methods of treating heavy menstrual bleeding |
Mar, 2034
(9 years from now) | Active |
| US11045470 | Methods of treating heavy menstrual bleeding |
Mar, 2034
(9 years from now) | Active |
| US11459305 | Processes for the preparation of uracil derivatives |
Nov, 2028
(3 years from now) | Active |
| 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 Oriahnn (copackaged)'s patents.
Latest Legal Activities on Oriahnn (copackaged)'s Patents
Given below is the list of recent legal activities going on the following patents of Oriahnn (copackaged).
| 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 |
| Email Notification Critical | 27 Jun, 2024 | US11459305 |
| Mail Pub Notice re 312 amendment | 27 Jun, 2024 | US11459305 |
| Mail Certificate of Correction Memo | 25 Jun, 2024 | US11459305 |
| POST ISSUE OTHER COMMUNICATION TO APPLICANT- CERTIFICATE OF CORRECTION | 24 Jun, 2024 | US11459305 |
| Certificate of Correction Memo | 22 Jun, 2024 | US11459305 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Jun, 2024 | US10881659 |
| Mail Certificate of Correction Memo | 14 Sep, 2023 | US11542239 |
FDA has granted several exclusivities to Oriahnn (copackaged). Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Oriahnn (copackaged), 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 Oriahnn (copackaged).
Exclusivity Information
Oriahnn (copackaged) holds 2 exclusivities. All of its exclusivities have expired in 2023. Details of Oriahnn (copackaged)'s exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 29, 2023 |
| New Chemical Entity Exclusivity(NCE) | Jul 23, 2023 |
US patents provide insights into the exclusivity only within the United States, but Oriahnn (copackaged) 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 Oriahnn (copackaged)'s family patents as well as insights into ongoing legal events on those patents.
Oriahnn (copackaged)'s Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Oriahnn (copackaged)'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)
Oriahnn (copackaged) Generics:
There are no approved generic versions for Oriahnn (copackaged) as of now.
How can I launch a generic of Oriahnn (copackaged) before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Oriahnn (copackaged)'s patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Oriahnn (copackaged)'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 Oriahnn (copackaged) -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 300 mg/1 mg/ 0.5 mg; 300 mg | 03 Nov, 2022 | 1 | 14 Mar, 2034 |
About Oriahnn (copackaged)
Oriahnn (Copackaged) is a drug owned by Abbvie Inc. It is used for managing heavy menstrual bleeding associated with uterine leiomyomas (fibroids) with the use of elagolix and omeprazole. Oriahnn (Copackaged) uses Elagolix Sodium,Estradiol,Norethindrone Acetate; Elagolix Sodium as an active ingredient. Oriahnn (Copackaged) was launched by Abbvie in 2020.
Approval Date:
Oriahnn (copackaged) was approved by FDA for market use on 29 May, 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 Oriahnn (copackaged) is 29 May, 2020, its NCE-1 date is estimated to be 23 July, 2022.
Active Ingredient:
Oriahnn (copackaged) uses Elagolix Sodium,estradiol,norethindrone Acetate; Elagolix Sodium as the active ingredient. Check out other Drugs and Companies using Elagolix Sodium,estradiol,norethindrone Acetate; Elagolix Sodium ingredient
Treatment:
Oriahnn (copackaged) is used for managing heavy menstrual bleeding associated with uterine leiomyomas (fibroids) with the use of elagolix and omeprazole.
Dosage:
Oriahnn (copackaged) is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE | CAPSULE | Prescription | ORAL |