Obeticholic Acid Patent Expiration
Obeticholic Acid is used for treating Primary Biliary Cholangitis (PBC) in adults. It was first introduced by Intercept Pharmaceuticals Inc
Obeticholic Acid Patents
Given below is the list of patents protecting Obeticholic Acid, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Ocaliva | US10052337 | Compositions of obeticholic acid and methods of use | Apr 26, 2036 | Intercept Pharms Inc |
| Ocaliva | US10751349 | Compositions of obeticholic acid and methods of use | Apr 26, 2036 | Intercept Pharms Inc |
| Ocaliva | US10758549 | Compositions of obeticholic acid and methods of use | Apr 26, 2036 | Intercept Pharms Inc |
| Ocaliva | US10047117 | Preparation and uses of obeticholic acid | Sep 06, 2033 | Intercept Pharms Inc |
| Ocaliva | US10174073 | Preparation and uses of obeticholic acid | Jun 17, 2033 | Intercept Pharms Inc |
| Ocaliva | US9238673 | Preparation and uses of obeticholic acid | Jun 17, 2033 | Intercept Pharms Inc |
| Ocaliva | USRE48286 | Steroids as agonists for FXR | Feb 21, 2027 | Intercept Pharms Inc |
| Ocaliva | US7138390 | Steroids as agonists for FXR |
Nov 16, 2022
(Expired) | Intercept Pharms Inc |
| Ocaliva | US8058267 | Steroids as agonists for FXR |
Feb 21, 2022
(Expired) | Intercept Pharms Inc |
| Ocaliva | US8377916 | Steroids as agonists for FXR |
Feb 21, 2022
(Expired) | Intercept Pharms Inc |
Obeticholic Acid's Family Patents
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Obeticholic Acid Generic API Manufacturers
Several generic applications have been filed for Obeticholic Acid. The first generic version for Obeticholic Acid was by Apotex Inc and was approved on May 30, 2023. And the latest generic version is by Msn Laboratories Private Ltd and was approved on May 30, 2023.
Given below is the list of companies who have filed for Obeticholic Acid generic, along with the locations of their manufacturing plants worldwide.
1. APOTEX
Apotex Inc has filed for 2 different strengths of generic version for Obeticholic Acid. Given below are the details of the strengths of this generic introduced by Apotex.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Discontinued | ORAL | N/A | May 30, 2023 |
| 10MG | tablet | Discontinued | ORAL | N/A | May 30, 2023 |
Manufacturing Plant Locations New
Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.
| Country | City | Firm Name | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| Canada |
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| India |
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2. LUPIN LTD
Lupin Ltd has filed for 2 different strengths of generic version for Obeticholic Acid. Given below are the details of the strengths of this generic introduced by Lupin Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Discontinued | ORAL | N/A | May 30, 2023 |
| 10MG | tablet | Discontinued | ORAL | N/A | May 30, 2023 |
Manufacturing Plant Locations New
Lupin Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Lupin Ltd as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
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3. MSN
Msn Laboratories Private Ltd has filed for 2 different strengths of generic version for Obeticholic Acid. Given below are the details of the strengths of this generic introduced by Msn.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Discontinued | ORAL | N/A | May 30, 2023 |
| 10MG | tablet | Discontinued | ORAL | N/A | May 30, 2023 |
Manufacturing Plant Locations New
Msn's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Msn as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
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| United States |
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