By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
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OCALIVA Drug Profile
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When do Ocaliva patents expire, and what generic alternatives are available?
Ocaliva is a drug marketed by Intercept Pharms Inc and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and ten patent family members in thirty-five countries.
The generic ingredient in OCALIVA is obeticholic acid. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the obeticholic acid profile page.
DrugPatentWatch® Generic Entry Outlook for Ocaliva
Ocaliva was eligible for patent challenges on May 27, 2020.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 26, 2036. This may change due to patent challenges or generic licensing.
There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for OCALIVA
| International Patents: | 110 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 49 |
| Patent Applications: | 590 |
| Drug Prices: | Drug price information for OCALIVA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OCALIVA |
| What excipients (inactive ingredients) are in OCALIVA? | OCALIVA excipients list |
| DailyMed Link: | OCALIVA at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for OCALIVA
Generic Entry Date for OCALIVA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for OCALIVA
| Drug Class | Farnesoid X Receptor Agonist |
| Mechanism of Action | Farnesoid X Receptor Agonists |
ATC Classes for OCALIVA
Paragraph IV (Patent) Challenges for OCALIVA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| OCALIVA | TABLET;ORAL | obeticholic acid | 207999 | 2020-05-27 |
US Patents and Regulatory Information for OCALIVA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-001 | May 27, 2016 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-002 | May 27, 2016 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Y | Try Before You Buy | ||
| Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-002 | May 27, 2016 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-001 | May 27, 2016 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Y | Y | Try Before You Buy | ||
| Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-001 | May 27, 2016 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for OCALIVA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | 112014031828 | Try Before You Buy |
| Denmark | 1392714 | Try Before You Buy |
| Eurasian Patent Organization | 032347 | Try Before You Buy |
| Chile | 2014003475 | Try Before You Buy |
| Canada | 3009149 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for OCALIVA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1392714 | LUC00018 | Luxembourg | Try Before You Buy | PRODUCT NAME: ACIDE OBETICHOLIQUE ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (OCALIVA); AUTHORISATION NUMBER AND DATE: EU/1/16/1139 20161215 |
| 1392714 | 598 | Finland | Try Before You Buy | |
| 1392714 | 132017000061826 | Italy | Try Before You Buy | PRODUCT NAME: ACIDO OBETICOLICO(OCALIVA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1139, 20161215 |
| 1392714 | CR 2017 00025 | Denmark | Try Before You Buy | PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215 |
| 1392714 | 122017000034 | Germany | Try Before You Buy | PRODUCT NAME: OBETICHOLSAEURE; REGISTRATION NO/DATE: EU/1/16/1139 20161212 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
