Ocaliva is a drug owned by Intercept Pharmaceuticals Inc. It is protected by 10 US drug patents filed from 2016 to 2021. Out of these, 7 drug patents are active and 3 have expired. Ocaliva's patents have been open to challenges since 27 May, 2020. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 26, 2036. Details of Ocaliva'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. | |||
| US10174073 | Preparation and uses of obeticholic acid |
Jun, 2033
(8 years from now) | Active |
| USRE48286 | Steroids as agonists for FXR |
Feb, 2027
(1 year, 9 months from now) | Active |
| US7138390 | Steroids as agonists for FXR |
Nov, 2022
(2 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10758549 | Compositions of obeticholic acid and methods of use |
Apr, 2036
(10 years from now) | Active |
| US10052337 | Compositions of obeticholic acid and methods of use |
Apr, 2036
(10 years from now) | Active |
| US10751349 | Compositions of obeticholic acid and methods of use |
Apr, 2036
(10 years from now) | Active |
| US10047117 | Preparation and uses of obeticholic acid |
Sep, 2033
(8 years from now) | Active |
| US9238673 | Preparation and uses of obeticholic acid |
Jun, 2033
(8 years from now) | Active |
| US8058267 | Steroids as agonists for FXR |
Feb, 2022
(3 years ago) |
Expired
|
| US8377916 | Steroids as agonists for FXR |
Feb, 2022
(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 Ocaliva's patents.
Latest Legal Activities on Ocaliva's Patents
Given below is the list of recent legal activities going on the following patents of Ocaliva.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 01 Mar, 2024 | US10758549 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 Feb, 2024 | US10751349 |
| Expire Patent Critical | 18 Dec, 2023 | US8058267 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 Jul, 2023 | US9238673 |
| Maintenance Fee Reminder Mailed Critical | 03 Jul, 2023 | US8058267 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 08 Jul, 2022 | US10174073 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 Feb, 2022 | US10052337 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 Feb, 2022 | US10047117 |
| Mail-Petition Decision - Granted | 06 Nov, 2020 | US7138390 |
| Petition Decision - Granted Critical | 05 Nov, 2020 | US7138390 |
FDA has granted several exclusivities to Ocaliva. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ocaliva, 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 Ocaliva.
Exclusivity Information
Ocaliva holds 3 exclusivities. All of its exclusivities have expired in 2023. Details of Ocaliva's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 27, 2021 |
| Orphan Drug Exclusivity(ODE) | May 27, 2023 |
| Orphan Drug Exclusivity(ODE-119) | May 27, 2023 |
US patents provide insights into the exclusivity only within the United States, but Ocaliva 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 Ocaliva's family patents as well as insights into ongoing legal events on those patents.
Ocaliva's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ocaliva's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 26, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ocaliva Generic API suppliers:
Obeticholic Acid is the generic name for the brand Ocaliva. 3 different companies have already filed for the generic of Ocaliva, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ocaliva's generic
How can I launch a generic of Ocaliva before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ocaliva's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ocaliva'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 Ocaliva -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg and 10 mg | 27 May, 2020 | 5 | 30 May, 2023 | 26 Apr, 2036 | Eligible |
About Ocaliva
Ocaliva is a drug owned by Intercept Pharmaceuticals Inc. It is used for treating Primary Biliary Cholangitis (PBC) in adults. Ocaliva uses Obeticholic Acid as an active ingredient. Ocaliva was launched by Intercept Pharms Inc in 2016.
Approval Date:
Ocaliva was approved by FDA for market use on 27 May, 2016.
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 Ocaliva is 27 May, 2016, its NCE-1 date is estimated to be 27 May, 2020.
Active Ingredient:
Ocaliva uses Obeticholic Acid as the active ingredient. Check out other Drugs and Companies using Obeticholic Acid ingredient
Treatment:
Ocaliva is used for treating Primary Biliary Cholangitis (PBC) in adults.
Dosage:
Ocaliva is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG | TABLET | Prescription | ORAL |
| 10MG | TABLET | Prescription | ORAL |