OCALIVA Drug Patent Profile

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 seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-three patent family members in thirty-seven 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.

There have been eight 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.

There is one tentative approval for the generic drug (obeticholic acid), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for OCALIVA

International Patents:	123
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	4
Patent Applications:	531
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

See drug prices for OCALIVA

Recent Clinical Trials for OCALIVA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Intercept Pharmaceuticals	N/A
Universitaire Ziekenhuizen KU Leuven	N/A
M.D. Anderson Cancer Center	Phase 1

See all OCALIVA clinical trials

Pharmacology for OCALIVA

Drug Class	Farnesoid X Receptor Agonist
Mechanism of Action	Farnesoid X Receptor Agonists

Paragraph IV (Patent) Challenges for OCALIVA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OCALIVA	Tablets	obeticholic acid	5 mg and 10 mg	207999	5	2020-05-27

US Patents and Regulatory Information for OCALIVA

OCALIVA is protected by seven US patents.

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
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016		RX	Yes	No			Y
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016		RX	Yes	No				Y
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016		RX	Yes	Yes			Y
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016		RX	Yes	Yes

Expired US Patents for OCALIVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016

EU/EMA Drug Approvals for OCALIVA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
ADVANZ PHARMA Limited	Ocaliva	obeticholic acid	EMEA/H/C/004093 Ocaliva is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.	Authorised	no	no	yes	2016-12-12

International Patents for OCALIVA

When does loss-of-exclusivity occur for OCALIVA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

Israel

Japan

Mexico

Morocco

Nicaragua

Peru

Philippines

Singapore

South Africa

South Korea

Taiwan

Tunisia

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering OCALIVA around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	3336097
European Patent Office	1392714	STEROIDES COMME AGONISTES DE FXR (STEROIDS AS AGONISTS FOR FXR)
European Patent Office	3336097	PRÉPARATION DE LA FORME NON-CRYSTALLINE D'ACIDE OBETICHOLIQUE (PREPARATION OF THE NON-CRYSTALLINE FORM OF OBETICHOLIC ACID)
Hong Kong	1211296
Singapore	10201607230S

Supplementary Protection Certificates for OCALIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1392714	17C0003	France		PRODUCT NAME: ACIDE OBETICHOLIQUE; REGISTRATION NO/DATE: EU/1/16/1139 20161212
1392714	2017/019	Ireland		PRODUCT NAME: OBETICHOLIC ACID; REGISTRATION NO/DATE: EU/1/16/1139/001 EU/1/16/1139/002 20161212
1392714	598	Finland
1392714	CA 2017 00025	Denmark		PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215
1392714	CR 2017 00025	Denmark		PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215

Market Dynamics and Financial Trajectory for OCALIVA

Introduction to OCALIVA

OCALIVA, also known as obeticholic acid (OCA), is a farnesoid X receptor agonist developed by Intercept Pharmaceuticals. It is primarily used to treat primary biliary cholangitis (PBC), a chronic liver disease characterized by the progressive destruction of the bile ducts within the liver.

Mechanism of Action and Clinical Use

OCALIVA works by preventing the buildup of bile acid in the liver, thereby reducing liver damage and improving liver function. It was granted accelerated approval by the FDA in 2016 for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) or as monotherapy in patients who cannot tolerate UDCA[4].

Market Size and Forecast

The OCALIVA market has shown significant growth and is expected to continue expanding. As of 2023, the market size was valued at USD 1 billion and is projected to reach USD 8.2 billion by 2031, growing at a CAGR of 2.19% from 2024 to 2031. This growth is driven by the increasing incidence of chronic liver conditions, particularly PBC, and the rising awareness among healthcare professionals and patients about the efficacy of OCALIVA[3].

Geographical Market Analysis

The market for OCALIVA is analyzed across several key regions, including the United States, Germany, France, Italy, Spain, and the United Kingdom. Each of these markets is expected to contribute significantly to the overall growth of the OCALIVA market. For instance, the report provides detailed market size forecasts for OCALIVA in these regions from 2024 to 2032, highlighting the potential for market expansion in each area[1].

Financial Performance of Intercept Pharmaceuticals

Intercept Pharmaceuticals, the developer of OCALIVA, has reported notable financial results related to the drug. In 2017, worldwide net sales of OCALIVA were $129.2 million, with $37.3 million in the fourth quarter alone. Despite these revenues, Intercept reported a net loss of $360.4 million for the full year 2017, largely due to high research and development expenses and other operational costs[2].

In 2020, the company reported worldwide OCALIVA net sales of $312.7 million for the full year, representing a 25% growth from the previous year. This growth was driven by increased commercialization efforts and expanding market penetration[5].

Challenges and Regulatory Concerns

Despite its market growth, OCALIVA faces significant regulatory challenges. The FDA has raised concerns about the drug's efficacy and safety based on post-marketing data. The 747-302 trial failed to demonstrate efficacy on the primary composite endpoint of liver transplantation, death, and other liver-related outcomes. Additionally, the FDA's analysis showed unfavorable trends in liver transplantation and mortality associated with OCALIVA. These concerns have led to substantial changes in the drug's safety labels and have put its accelerated approval at risk[4].

Competitive Landscape

The market for PBC treatments is becoming increasingly competitive. Other emerging therapies are expected to provide tough competition to OCALIVA. The launch of late-stage emerging therapies in the near future will significantly impact the market dynamics, potentially altering the dominance of OCALIVA. Companies are developing novel approaches to treat PBC, which could challenge OCALIVA's market position[1].

SWOT Analysis

A comprehensive SWOT analysis highlights the strengths, weaknesses, opportunities, and threats associated with OCALIVA. Strengths include its unique mechanism of action and established market presence. However, weaknesses such as the recent regulatory concerns and safety issues pose significant risks. Opportunities lie in the growing awareness of PBC and the potential use of OCALIVA in other liver diseases like nonalcoholic steatohepatitis (NASH). Threats include the emergence of new competitors and the potential withdrawal of its accelerated approval[1].

Future Market Assessments

The future market assessments for OCALIVA are complex due to the current regulatory uncertainties. Despite these challenges, the market is expected to expand driven by the increasing incidence of chronic liver conditions and the growing trend of combination therapy in liver disease treatment. The report provides forecasted sales data from 2024 to 2032, which will be crucial for decision-making regarding therapeutic portfolios[1].

Analysts' Views

Analysts' views on OCALIVA are mixed, reflecting the drug's potential and the current regulatory hurdles. While some analysts see the drug as a promising treatment option for PBC, others are cautious due to the safety concerns and the potential impact on its market approval. The ongoing advisory committee meetings and the FDA's deliberations will be pivotal in determining the future trajectory of OCALIVA[1].

Key Takeaways

• OCALIVA is a significant player in the PBC treatment market, with a projected market size of USD 8.2 billion by 2031.
• The drug faces regulatory challenges, including concerns over its efficacy and safety.
• Market growth is driven by increasing awareness and the incidence of chronic liver conditions.
• Competitive landscape is evolving with new emerging therapies.
• SWOT analysis highlights both opportunities and threats for OCALIVA.

FAQs

What is OCALIVA used for?

OCALIVA (obeticholic acid) is used to treat primary biliary cholangitis (PBC), a chronic liver disease, often in combination with ursodeoxycholic acid (UDCA) or as monotherapy in patients who cannot tolerate UDCA.

What are the regulatory concerns surrounding OCALIVA?

The FDA has raised concerns about OCALIVA's efficacy and safety based on post-marketing data, including unfavorable trends in liver transplantation and mortality, which could lead to the withdrawal of its accelerated approval.

How is the market for OCALIVA expected to grow?

The OCALIVA market is expected to grow from USD 1 billion in 2023 to USD 8.2 billion by 2031, driven by the increasing incidence of chronic liver conditions and growing awareness among healthcare professionals and patients.

What are the potential threats to OCALIVA's market position?

Emerging therapies for PBC and potential regulatory actions, including the withdrawal of its accelerated approval, pose significant threats to OCALIVA's market dominance.

What other liver diseases could OCALIVA potentially be used for?

OCALIVA is being explored for its potential use in other liver diseases, such as nonalcoholic steatohepatitis (NASH), although these efforts have faced setbacks, including the abandonment of the MASH program.

Cited Sources:

1. GlobeNewswire, "OCALIVA for Primary Biliary Cirrhosis (PBC) Drug Landscape Report 2024: Market Size, Analysis, and Forecasts 2019-2023 and 2024-2032 Focus on United States, Germany, France, Italy, Spain, and UK" - March 1, 2024.
2. Business Insider, "Intercept Pharmaceuticals Reports Full Year and Fourth Quarter 2017 Financial Results and Provides Business Update" - February 14, 2018.
3. Market Research Intellect, "Global Ocaliva Market Size, Share, Outlook, Trend And Forecast" - November 2024.
4. BioSpace, "Intercept's Ocaliva in Jeopardy as FDA Questions Efficacy, Safety Ahead of AdComm" - September 12, 2024.
5. BioSpace, "Intercept Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results, Issues 2021 Financial Guidance and Provides Business Update" - February 25, 2021.