OCALIVA Drug Patent Profile

When do Ocaliva patents expire, and what generic alternatives are available?

Ocaliva is a drug marketed by Intercept 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.

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 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:	1,493
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OCALIVA

Constraining patent/regulatory exclusivity:

10,751,349

NDA:

207999

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.

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.

This potential generic entry date is based on patent 10,751,349.

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Intercept	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016		DISCN	Yes	No	10,758,549
Intercept	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016		DISCN	Yes	No	9,238,673		Y
Intercept	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016		DISCN	Yes	No	10,174,073			Y
Intercept	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016		DISCN	Yes	No	10,052,337		Y

Expired US Patents for OCALIVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Intercept	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016	7,138,390
Intercept	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016	7,138,390
Intercept	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016	8,377,916
Intercept	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/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
Australia	2013277429
Australia	2016200832
Australia	2016375566
Australia	2017204057

Supplementary Protection Certificates for OCALIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1392714	300877	Netherlands		PRODUCT NAME: OBETICHOLZUUR; REGISTRATION NO/DATE: EU/1/16/1139 20161215
1392714	CA 2017 00025	Denmark		PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: 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

Last updated: June 6, 2026

OCALIVA (obeticholic acid) Market Dynamics and Financial Trajectory (U.S. and Key Ex-US Exposures)

OCALIVA (obeticholic acid, OCA) is a niche, high-visibility bile acid program tied to two liver disease indications that have shaped pricing, payer access, and competition. In the U.S., sales are dominated by retail and specialty pharmacy distribution under strict payer utilization management, with long-term revenue trajectory constrained by (1) a capped segment size for PBC, (2) evolving treatment paradigms, and (3) declining certainty for future label growth outside established populations. Ex-US dynamics are similarly dependent on local guideline adoption and reimbursement, with post-approval safety data and sequencing influencing share more than broad-based market expansion.

No complete, decision-grade financial trajectory (multi-year sales trend with quantified CAGR, region splits, and latest quarterly revenue) can be produced here because the prompt does not provide the underlying commercial dataset and no cited sales record is supplied.

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What drives OCALIVA market dynamics in primary biliary cholangitis (PBC) and PSC?

How does OCALIVA’s payer and utilization structure affect net sales?

OCALIVA is priced at a specialty drug level and historically has faced payer requirements that narrow eligible patients, including:

• Demonstrated PBC diagnosis consistent with label criteria
• Inadequate response to ursodeoxycholic acid (UDCA) or intolerance to UDCA (label-dependent)
• Prior authorization and step edits based on liver function and prior therapy
• Specialty pharmacy dispensing and dose monitoring requirements

These levers reduce addressable volume even when patient incidence is stable.

What safety and tolerability issues have mattered for commercial uptake?

Commercial uptake has been strongly influenced by tolerability and adverse-event management, particularly:

• Pruritus and dose-related adverse effects affecting adherence and switch behavior
• Treatment discontinuation risk in real-world populations when symptom management is inadequate
• Clinical sequencing pressure (patients moved earlier vs later depending on guideline interpretation)

Even small discontinuation differences can materially impact revenue in a niche segment.

How does competitor behavior shape OCALIVA share?

PBC’s competitive set has been shaped by:

• UDCA remain foundational and is widely covered
• Second-line agents and combination strategies affect timing of OCA placement
• Shifts in guideline recommendations and hepatology practice patterns change who gets OCA and when

For PSC, uptake is more constrained by heterogeneous patient subtypes, trial-driven positioning, and reimbursement risk.

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What is OCALIVA’s financial trajectory and revenue exposure by indication?

How are PBC and PSC exposures likely to map to revenue durability?

OCALIVA’s revenue durability depends on the share of patients that remain on therapy long enough to support chronic-revenue retention. In general, the financial pattern for bile-acid pathway drugs is:

• Initial ramp driven by patient identification and specialty prescriber adoption
• A mid-phase shaped by payer tightening and adherence persistence
• Later-phase shaped by label evolution, competitor entries, and safety-driven discontinuation

For decision purposes, the key commercial distinction is that PBC has a defined chronic treated population, while PSC volumes are more volatile and sensitive to subgroup eligibility and regional reimbursement policies.

What financial risks exist from label expansion or contraction?

Financial exposure is tied to whether the label changes expand the treatable pool without worsening coverage:

• Label expansion can increase patient flow but can also trigger payer pushback if evidence standards are interpreted narrowly
• Safety signals can accelerate discontinuations and worsen prior auth outcomes
• Any indication restriction can reduce the top-of-funnel for new starts

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When do exclusivity, generic entry risk, and biosimilar risk affect OCALIVA’s revenue outlook?

Is OCALIVA protected from generic competition for the near term?

OCALIVA is a small-molecule drug. Generic “biosimilar” risk is not the applicable threat; the threat is small-molecule generic entry and authorized generics. The timing is determined by:

• Composition-of-matter patent expiry
• Method-of-use and formulation patent coverage
• Hatch-Waxman Paragraph IV filing activity
• Exclusivity from regulatory milestones and any pediatric-related exclusivity

A complete, accurate exclusivity and patent-expiration timeline cannot be constructed from the information provided in the prompt.

What generic launch scenarios typically impact niche specialty revenue?

For specialty bile-acid drugs, launch dynamics often include:

• Delayed market penetration due to payer preferencing and prior auth inertia
• Dose conversion and persistence effects when generics require different NDC switching
• Patent-driven settlements that delay first ANDA approval date even if an ANDA is filed

Without the patent and Orange Book record for OCALIVA, a launch-scenario timetable cannot be stated.

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What Orange Book status, patent estate strength, and litigation posture affect commercial durability?

How does OCALIVA’s patent estate influence market share protection?

A drug’s patent estate strength is the primary determinant of whether generics can enter quickly after core patent expiry. For specialty hepatology drugs, the practical effect is:

• Strong formulation and method-of-use patents can block “at-label” designs, forcing design-arounds that slow uptake
• Litigation timing can extend exclusivity-like market protection through settlement terms

A decision-grade patent estate assessment for OCALIVA requires the Orange Book patent list and litigation docket references, which are not supplied in the prompt.

What patent litigation affects investor and payer expectations?

Investors typically monitor:

• Paragraph IV filings
• District court schedules (HIT deadlines, Markman, trial, appeal)
• Settlement agreements that specify entry dates and launch carve-outs

A litigation-driven timeline cannot be produced without case identifiers and settlements.

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How does OCALIVA’s FDA regulatory status influence commercial timing and payer confidence?

What FDA label features affect real-world prescribing?

Commercial adoption is driven by label specifics such as:

• Treatment lines (UDCA-refractory vs UDCA-intolerant)
• Use limitations by disease severity proxies
• Any boxed warnings or dose limitations impacting real-world prescribing comfort

How do FDA post-marketing updates shift reimbursement?

Safety communications, label updates, and risk-management changes can:

• Trigger tighter prior authorization criteria
• Slow formulary listing
• Increase prescriber hesitation, especially for symptom-prone populations

A complete regulatory trajectory cannot be built here without the FDA approval history and subsequent safety communications.

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How does OCALIVA compare with alternative PBC/PSC therapies on market positioning?

What treatment-line sequencing reduces OCA addressability?

OCA’s addressability depends on where it sits in sequencing against:

• UDCA continued use and intolerance definitions
• Other second-line agents for PBC
• For PSC, use depends heavily on subpopulation fit and guideline endorsement

What commercial KPIs show competitive displacement?

For specialty liver drugs, the leading indicators are:

• Uptake in new-to-brand prescriptions
• Persistence and discontinuation rates
• Formulary and restriction changes across top plans
• Specialty pharmacy fill rates and switching volumes

Without sales and claims data, competitive displacement cannot be quantified.

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Which companies are most exposed to OCALIVA revenue changes through co-promotion, manufacturing, or distribution?

How do contract manufacturing and distribution relationships create financial contagion?

Revenue can be affected by:

• Contract manufacturing availability and cost changes
• Specialty pharmacy network shifts that change channel efficiency
• Wholesale distribution constraints or NDC-level supply disruptions

A company-level exposure map requires manufacturer and commercial partner disclosures, not provided in the prompt.

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What Key Takeaways apply to OCALIVA’s market and financial outlook?

• OCALIVA’s market dynamics are driven by specialty payer access controls, real-world tolerability, and hepatology treatment sequencing in PBC.
• Financial trajectory is constrained by niche patient volume in the core segment and by volatility in PSC uptake tied to payer and guideline behavior.
• Small-molecule generic entry risk and any litigation-driven delays are the primary structural determinants of long-run revenue, but an accurate timeline cannot be produced without the OCALIVA Orange Book and patent/litigation dataset.

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FAQs

1. How do prior authorization criteria for OCALIVA affect new patient starts in PBC?
2. What tolerability factors drive OCALIVA discontinuation and adherence differences in claims data?
3. Does OCALIVA have higher uptake in specific liver-function strata, and how does that affect forecasting?
4. What Paragraph IV filings exist for OCALIVA-related patents, and what do they imply for generic entry risk?
5. How do payer formulary changes across top commercial insurers typically alter OCALIVA net sales within a year?

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References (APA)

No sources were provided in the prompt, and no cited dataset is included above.