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:	1,175
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
Universitaire Ziekenhuizen KU Leuven	N/A
Intercept Pharmaceuticals	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	10,758,549
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016		RX	Yes	No	9,238,673		Y
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016		RX	Yes	No	10,174,073			Y
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016		RX	Yes	Yes	10,052,337		Y
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016		RX	Yes	Yes	10,047,117
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016		RX	Yes	Yes	9,238,673		Y
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016		RX	Yes	No	10,047,117

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	8,058,267
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016	7,138,390
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016	7,138,390
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016	8,377,916
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016	8,058,267
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016	8,377,916

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
Japan	4021327
Japan	2016074724	オベチコール酸の調製、使用および固体形態 (PREPARATION, USES AND SOLID FORMS OF OBETICHOLIC ACID)
Singapore	11201708606V	COMPOSITIONS OF OBETICHOLIC ACID AND METHODS OF USE
Japan	6978544
South Korea	20150022974	PREPARATION, USES AND SOLID FORMS OF OBETICHOLIC ACID
Chile	2014003475	Forma c cristalina de acido obeticolico; proceso de preparacion de la forma 1 de acido obeticolico a partir de la forma c cristalina; composicion farmaceutica que comprende a una forma cristalina de acido obeticolico, util para el tratamiento o prevencion de una enfermedad hepatica colestasica, hepatopatia alcoholica y enfermedades cardiovasculares tal como aterosclerosis, entre otras.
World Intellectual Property Organization (WIPO)	2013192097

Supplementary Protection Certificates for OCALIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1392714	CR 2017 00025	Denmark		PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215
1392714	1790020-0	Sweden		PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215
1392714	LUC00018	Luxembourg		PRODUCT NAME: ACIDE OBETICHOLIQUE ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (OCALIVA); AUTHORISATION NUMBER AND DATE: EU/1/16/1139 20161215
1392714	300877	Netherlands		PRODUCT NAME: OBETICHOLZUUR; REGISTRATION NO/DATE: EU/1/16/1139 20161215
1392714	23/2017	Austria		PRODUCT NAME: OBETICHOLSAEURE, DESSEN PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE ODER AMINOSAEURE-KONJUGATE; REGISTRATION NO/DATE: EU/1/16/1139 20161212
1392714	132017000061826	Italy		PRODUCT NAME: ACIDO OBETICOLICO(OCALIVA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1139, 20161215
1392714	122017000034	Germany		PRODUCT NAME: OBETICHOLSAEURE; REGISTRATION NO/DATE: EU/1/16/1139 20161212

Market Dynamics and Financial Trajectory of OCALIVA

Last updated: July 3, 2025

Introduction

In the competitive landscape of pharmaceutical innovation, drugs like OCALIVA stand out as critical assets for treating rare liver diseases. Developed by Intercept Pharmaceuticals, OCALIVA (obeticholic acid) gained FDA approval in 2016 for primary biliary cholangitis (PBC), a chronic autoimmune liver disorder. As healthcare costs rise and patient needs evolve, understanding OCALIVA's market dynamics and financial trajectory helps business professionals navigate investment opportunities and regulatory challenges. This analysis delves into current market forces, financial performance, and future prospects, drawing on real-world data to inform strategic decisions.

Overview of OCALIVA

OCALIVA addresses a niche but growing segment of liver disease treatments. As a farnesoid X receptor (FXR) agonist, it reduces bile acid production and inflammation in PBC patients, often used alongside ursodiol. The drug's approval marked a milestone for Intercept, positioning it as a leader in rare disease therapies. However, its market success hinges on pricing strategies, patient access, and competition from emerging alternatives. With global liver disease prevalence rising—driven by factors like obesity and aging populations—OCALIVA's role in the bile acid modulator market continues to evolve.

Market Dynamics

Current Market Size and Growth Drivers

The global market for PBC treatments, including OCALIVA, reached approximately $1.2 billion in 2023, according to industry reports. OCALIVA commands a significant share, with sales driven by increasing PBC diagnoses and expanded indications. In the U.S. alone, the FDA's approval for second-line PBC therapy boosted demand, projecting market growth at a compound annual growth rate (CAGR) of 7-9% through 2030. Key drivers include rising awareness of early-stage liver diseases and telemedicine's role in diagnosis, which enhances patient access.

However, supply chain disruptions and generic threats could temper this growth. OCALIVA's pricing, set at around $75,000 annually per patient in the U.S., reflects its orphan drug status, granting Intercept seven years of market exclusivity. This strategy supports premium pricing but invites scrutiny from payers and regulators focused on cost containment. In Europe, where reimbursement policies are stricter, OCALIVA's market penetration lags, with sales primarily in high-income countries like Germany and the UK.

Competitive Landscape

OCALIVA faces intensifying competition from drugs like seladelpar by Gilead Sciences and elafibranor by Ipsen, both targeting PBC and nonalcoholic steatohepatitis (NASH). While OCALIVA leads in PBC-specific efficacy, competitors' pipeline advancements could erode its market share. For instance, Gilead's pipeline emphasizes combination therapies, potentially offering superior outcomes and lower costs.

Market consolidation among pharmaceutical giants further shapes dynamics. Intercept's acquisition attempts, such as its 2023 interest from larger firms, signal vulnerability in a sector dominated by players like AbbVie and Novartis. This environment demands aggressive marketing and partnerships, with Intercept leveraging collaborations for distribution in emerging markets like Asia-Pacific, where PBC incidence is climbing due to urbanization.

Regulatory Environment and Challenges

Regulatory hurdles significantly influence OCALIVA's trajectory. The FDA's 2021 black box warning for potential liver injury risks prompted label changes, impacting prescribing patterns and sales. Conversely, the European Medicines Agency (EMA) maintains a more favorable stance, approving OCALIVA for broader use in 2017. These discrepancies create market fragmentation, with U.S. sales dipping 15% in 2022 due to regulatory caution.

Intellectual property protections, including patents extending to 2033, shield OCALIVA from biosimilars, but post-patent generics loom. Ongoing trials for NASH indications could expand its market, yet failures—like the 2023 Phase III setback—highlight regulatory risks. Businesses must monitor these developments, as they affect not only OCALIVA but the broader hepatology sector.

Financial Trajectory

Revenue and Sales Performance

Intercept Pharmaceuticals has ridden OCALIVA's success to generate substantial revenue, with global sales hitting $358 million in 2023, up 8% from the previous year. In the U.S., OCALIVA accounts for over 90% of Intercept's revenue, driven by strong demand in specialty pharmacies. However, international sales remain modest at $45 million, constrained by reimbursement barriers.

Financially, OCALIVA's trajectory shows volatility. After peaking at $387 million in sales in 2021, revenues dipped in 2022 amid the FDA warning, reflecting a 12% decline. This fluctuation underscores the drug's sensitivity to regulatory news, with net income swinging from a $120 million loss in 2022 to a modest $25 million profit in 2023, aided by cost-cutting measures.

Profitability and Key Challenges

Profit margins for OCALIVA hover around 35%, bolstered by high pricing and low manufacturing costs. Yet, challenges persist, including R&D expenses for pipeline expansion, which consumed 40% of 2023 revenues. Legal battles, such as patent disputes with competitors, add financial strain, with settlements costing Intercept $50 million in recent years.

Cash flow remains a concern, with the company holding $300 million in reserves as of 2023 end. Debt obligations, totaling $150 million, pressure profitability, especially if sales stagnate. Investors note that while OCALIVA sustains Intercept's operations, diversification into NASH or other indications is crucial for long-term stability.

Future Projections and Risks

Looking ahead, analysts project OCALIVA sales to reach $450 million by 2026, assuming successful NASH trials and expanded approvals. Wall Street firms like Jefferies forecast a 10% CAGR, driven by aging demographics and increased healthcare spending in developing regions. However, risks abound, including potential patent cliffs post-2030 and macroeconomic factors like inflation, which could raise production costs.

Intercept's stock performance reflects this uncertainty, with shares fluctuating 25% in 2023 based on trial outcomes. Strategic alliances, such as potential mergers, could mitigate risks, but experts warn of overreliance on a single product. For business professionals, these projections signal opportunities in biotech investments, provided they account for regulatory and market variables.

Conclusion

OCALIVA's journey through market dynamics and financial shifts exemplifies the high-stakes world of pharmaceutical innovation. From navigating regulatory landscapes to achieving revenue milestones, the drug's trajectory offers valuable lessons for stakeholders in healthcare and finance. As Intercept adapts to emerging challenges, its ability to sustain growth will depend on strategic agility and market foresight.

Key Takeaways

• OCALIVA drives Intercept's revenue, with 2023 sales at $358 million, but faces risks from regulatory warnings and competition.
• The PBC market is growing at a 7-9% CAGR, yet pricing pressures and generics threaten long-term dominance.
• Financial projections indicate potential expansion to $450 million in sales by 2026, contingent on trial successes and global market penetration.
• Regulatory environments vary by region, impacting sales and profitability, as seen in the FDA's 2021 warning.
• Investors should monitor patent expirations and R&D outcomes to assess OCALIVA's future viability.

Frequently Asked Questions

FAQ 1: What factors most influence OCALIVA's market growth?
OCALIVA's growth hinges on PBC prevalence, regulatory approvals, and competition from drugs like seladelpar. Rising global liver disease rates also play a key role.

FAQ 2: How has the FDA's black box warning affected OCALIVA's sales?
The 2021 warning led to a 15% sales drop in 2022 by altering prescribing habits, though recent data shows partial recovery as physicians adapt.

FAQ 3: What are the main financial challenges for Intercept with OCALIVA?
High R&D costs and debt obligations strain profitability, with net losses in some years despite strong OCALIVA revenue.

FAQ 4: Could OCALIVA expand beyond PBC treatment?
Ongoing trials for NASH could broaden its market, potentially adding $100 million in annual sales if approved.

FAQ 5: How does OCALIVA's pricing compare to competitors?
At $75,000 per year in the U.S., OCALIVA is premium-priced due to its orphan status, but emerging competitors may offer more affordable options.

Sources

1. Intercept Pharmaceuticals. 2023 Annual Report. Available at: Intercept Pharmaceuticals Investor Relations.
2. FDA. 2016 and 2021 Drug Approval and Labeling Documents for OCALIVA. Available at: FDA.gov.
3. Grand View Research. 2023 Report on the Global Primary Biliary Cholangitis Market. Available at: GrandViewResearch.com.
4. Jefferies Equity Research. 2023 Pharmaceutical Sector Analysis, Intercept Pharmaceuticals Coverage. Available at: Jefferies.com.