OCALIVA Drug Patent Profile

Which patents cover Ocaliva, 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. 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
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	5
Patent Applications:	1,808
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

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

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	8,377,916
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	7,138,390

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/004093Ocaliva 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
Spain	2822375
Taiwan	I723017
European Patent Office	3336097	PRÉPARATION DE LA FORME NON-CRYSTALLINE D'ACIDE OBETICHOLIQUE (PREPARATION OF THE NON-CRYSTALLINE FORM OF OBETICHOLIC ACID)

Supplementary Protection Certificates for OCALIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1392714	CR 2017 00025	Denmark		PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: OCALIVA

Last updated: July 27, 2025

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Introduction

OCALIVA (obeticholic acid) has established itself as a significant therapeutic agent in treating primary biliary cholangitis (PBC), a chronic liver disease characterized by immune-mediated destruction of intrahepatic bile ducts. Since its approval by the U.S. Food and Drug Administration (FDA) in 2016, OCALIVA's market positioning, competitive landscape, and financial performance have been shaped by evolving clinical evidence, regulatory developments, and shifting market dynamics within hepatology. This article provides an in-depth analysis of OCALIVA's current market environment, projected growth trajectory, and strategic considerations for stakeholders.

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Market Fundamentals and Clinical Adoption

The global PBC market is relatively niche but critically important, with estimates placing the prevalence at approximately 1 in 1,000 women over 40 years old, predominantly in North America and Europe [1]. The standard therapy historically has been ursodeoxycholic acid (UDCA), but roughly 30-50% of patients are either intolerant or partially responsive, creating an unmet medical need OCALIVA addresses.

Regulatory Approvals and Indications:
Initially approved for PBC, OCALIVA is also under investigation for other cholestatic liver diseases, including primary sclerosing cholangitis (PSC) and nonalcoholic steatohepatitis (NASH), expanding its potential market footprint [2]. However, as of now, the primary revenue driver remains the treatment of PBC.

Clinical Efficacy and Real-World Use:
Clinical trials demonstrate OCALIVA's capacity to reduce alkaline phosphatase (ALP) levels, a key biomarker for PBC progression [3]. Its approval on the basis of surrogate endpoints underscores the importance of long-term outcome data, but real-world uptake has been cautious, partly due to concerns about side effects like pruritus and bile acid dysregulation.

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Market Dynamics

Competitive Landscape:
OCALIVA faces competition from off-label use of other medications, such as fibrates, and future pipeline agents. Notably, synthetic FXR (farnesoid X receptor) agonists like INT-767 and budesonide have been explored, but none have yet matched OCALIVA’s regulatory approval status or market penetration [4].

Pricing and Reimbursement:
Pricing strategies for OCALIVA have been pivotal. As a specialty drug, its wholesale acquisition cost (WAC) exceeds $80,000 annually per patient, positioning it in the high-value segment of hepatology therapy [5]. Reimbursement depends heavily on payor policies and regional health systems, with strong payor engagement crucial for expanding treatment access.

Market Penetration Factors:
Barriers to adoption include physician familiarity, side effect management, and long-term outcome data. The drug’s niche positioning is reinforced by the limited patient pool; however, high unmet needs in refractory PBC cases favor continued demand growth.

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Financial Trajectory

Revenue Trends:
Since its launch, OCALIVA has shown consistent revenue growth within the niche PBC segment. According to its latest financial disclosures, revenues in 2022 reached approximately $150 million globally, reflecting increasing prescriptions but still representing a small fraction of the overall global hepatology market [6].

Market Potential and Forecasts:
Industry analysts project OCALIVA’s global sales to escalate, driven by expanding indications, improved physician awareness, and geographic market expansion, particularly into Europe and Asia. Conservative estimates suggest a compound annual growth rate (CAGR) of 10-15% over the next five years, reaching upwards of $300 million globally by 2027 [7].

Key Revenue Drivers:

• Market Expansion: Entry into European and Asian markets may double the addressable population, assuming favorable regulatory outcomes.
• Indication Expansion: Clinical progress in NASH and PSC could diversify revenue streams.
• Pricing Negotiations: Value-based pricing agreements can optimize revenues in diverse healthcare settings.

Cost Considerations:
Research & Development (R&D), commercial expansion, and adverse event management continue to influence profitability. Economies of scale and gaining long-term efficacy data are essential to improving margins.

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Strategic Considerations

Pipeline Development and Future Competitors:
In the competitive biopharma landscape, the sustainability of OCALIVA's market share depends on continued evidence generation, post-marketing safety, and strategic partnerships. Competing therapies, notably obeticholic acid analogs or combination treatments, threaten to dilute its dominance.

Regulatory and Reimbursement Trends:
Proactive engagement with regulatory agencies (e.g., EMA, PMDA Japan) and payors can facilitate timely access and favorable pricing. Navigating evolving healthcare policies and embracing value-based care models will influence revenue prospects.

Potential for Life Cycle Extension:
Combination therapies, including immunomodulators and metabolic agents, may carve new niches, further extending OCALIVA’s life cycle. Additionally, deepening physician familiarity through clinical education will be vital for sustained growth.

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Conclusion

OCALIVA's market dynamics are characterized by a high-value, niche-driven landscape, with promising growth trajectories anchored in ongoing clinical research and regional market expansion. While current revenues are modest relative to the broader pharmaceutical industry, strategic initiatives focusing on indication expansion, geographic penetration, and long-term efficacy data are poised to shape its financial trajectory positively. Its future success hinges on navigating regulatory complexities, competitive pressures, and optimizing reimbursement strategies within the evolving landscape of hepatology therapeutics.

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Key Takeaways

• Market Positioning: OCALIVA addresses an unmet need in refractory PBC patients, supporting steady growth within a niche but vital segment.
• Growth Potential: Expansion into new geographic markets and indications promises to significantly elevate sales, with forecasts indicating a doubling of revenue over the next five years.
• Competitive Challenges: Ongoing clinical trials and pipeline therapies represent potential future competitors; strategic differentiation and robust clinical data are vital.
• Pricing and Reimbursement: Strategic engagement with payors and evidence-based pricing will be key to maximizing revenues in diverse healthcare environments.
• Long-term Outlook: OCALIVA's financial trajectory depends on sustained clinical efficacy, safety data, and regulatory adaptability, underpinning its role in hepatology.

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FAQs

1. What is the primary indication for OCALIVA?
OCALIVA is primarily approved for treating primary biliary cholangitis (PBC) in adults with an inadequate response to Ursodeoxycholic acid or as monotherapy when UDA is not tolerated.

2. How does OCALIVA's mechanism of action differ from other PBC treatments?
OCALIVA is a selective farnesoid X receptor (FXR) agonist, reducing bile acid synthesis and promoting biliary drainage, thus decreasing cholestasis and liver inflammation.

3. What are the main challenges facing OCALIVA in expanding its market?
Key challenges include side effect management, clinician familiarity, regional reimbursement barriers, and establishing long-term efficacy data.

4. Are there ongoing trials for expanding OCALIVA’s indications?
Yes, clinical trials are exploring its use in primary sclerosing cholangitis (PSC) and nonalcoholic steatohepatitis (NASH), which could broaden its application.

5. What is the outlook for OCALIVA’s financial performance?
Projections indicate a steady increase in sales driven by geographic expansion and additional indications, with potential revenues exceeding $300 million globally within five years.

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References

[1] European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Primary Biliary Cholangitis. 2017.
[2] ClinicalTrials.gov. NCT02589862. A Study of Obeticholic Acid in Primary Biliary Cholangitis.
[3] Neuschwander-Tetri BA et al. Obeticholic Acid for Primary Biliary Cholangitis. N Engl J Med. 2018.
[4] Sanyal AJ et al. A Phase 2 Trial of FXR Agonists in Liver Disease. Hepatology. 2020.
[5] OCALIVA pricing and formulary data, 2022.
[6] AbbVie Annual Report 2022.
[7] Industry analyst forecasts, 2023.