Obeticholic acid - Generic Drug Details

What are the generic sources for obeticholic acid and what is the scope of patent protection?

Obeticholic acid is the generic ingredient in two branded drugs marketed by Apotex, Lupin, MSN, and Intercept, and is included in four NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Obeticholic acid has one hundred and twenty-three patent family members in thirty-seven countries.

There is one drug master file entry for obeticholic acid. There is one tentative approval for this compound.

Summary for obeticholic acid

International Patents:	123
US Patents:	7
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	40
Patent Applications:	2,161
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for obeticholic acid
What excipients (inactive ingredients) are in obeticholic acid?	obeticholic acid excipients list
DailyMed Link:	obeticholic acid at DailyMed

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

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 obeticholic acid

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

Sponsor	Phase
Assiut University	PHASE3
Intercept Pharmaceuticals	PHASE3
Intercept Pharmaceuticals	Phase 2/Phase 3

See all obeticholic acid clinical trials

Generic filers with tentative approvals for OBETICHOLIC ACID

Applicant	Application No.	Strength	Dosage Form
		10mg	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for obeticholic acid

A05AA	Bile acids and derivatives
A05A	BILE THERAPY
A05	BILE AND LIVER THERAPY
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for OBETICHOLIC ACID

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 obeticholic acid

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin	OBETICHOLIC ACID	obeticholic acid	TABLET;ORAL	214980-002	May 30, 2023		DISCN	No	No
Intercept	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016		DISCN	Yes	No
Intercept	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016		DISCN	Yes	No			Y
Intercept	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016		DISCN	Yes	No				Y

Expired US Patents for obeticholic acid

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

EU/EMA Drug Approvals for obeticholic acid

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 obeticholic acid

Country	Patent Number	Title	Estimated Expiration
Australia	2013277429
Australia	2016200832
Australia	2016375566
Australia	2017204057

Supplementary Protection Certificates for obeticholic acid

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	LUC00018	Luxembourg		PRODUCT NAME: ACIDE OBETICHOLIQUE ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (OCALIVA); AUTHORISATION NUMBER AND DATE: EU/1/16/1139 20161215
1392714	132017000061826	Italy		PRODUCT NAME: ACIDO OBETICOLICO(OCALIVA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1139, 20161215
1392714	2017/019	Ireland		PRODUCT NAME: OBETICHOLIC ACID; REGISTRATION NO/DATE: EU/1/16/1139/001 EU/1/16/1139/002 20161212

Market Dynamics and Financial Trajectory for Obeticholic Acid

Last updated: March 4, 2026

Obeticholic acid (OCA) is a bile acid analog developed by Intercept Pharmaceuticals. Approved in the U.S. for primary biliary cholangitis (PBC), its potential in non-alcoholic steatohepatitis (NASH) and other liver diseases influences market projections. The drug’s commercial future hinges on regulatory approvals, clinical trial outcomes, competitive landscape, and evolving disease prevalence.

Regulatory Status and Approvals

Primary Biliary Cholangitis (PBC):

• FDA approval: July 2016, for PBC patients who do not respond to ursodeoxycholic acid (UDCA) or are intolerant.
• EMA approval: June 2017.

Non-Alcoholic Steatohepatitis (NASH):

• Phase 3 trials: REGENERATE trial results announced in June 2022 showed promising liver fibrosis improvements.
• Regulatory pathway: Awaiting submission based on trial outcomes; pivotal for expanding market penetration.

Other Indications:

• Investigated for conditions like primary sclerosing cholangitis and fatty liver disease.

Market Size and Forecasts

Current Market for PBC

• Prevalence: Estimated at 10-16 cases per 100,000 in Western populations.
• Market value (2022): Approximately $500 million globally.
• Treatment rate: UDCA used as first-line; OCA serves as second-line for refractory cases.

NASH Market Potential

• Prevalence: Approximately 3-5% of global population; US NASH population estimates near 30 million.
• Future market size: Enterprise estimates project $20 billion globally by 2030.
• Growth drivers: Rising obesity, diabetes, and metabolic syndrome increase NASH cases.

Competitive Landscape

Drug Candidate	Developer	Indication	Status	Market Share (Projected 2025)
Obeticholic acid	Intercept Pharma	PBC, NASH	Approved for PBC; Phase 3 NASH	~60% (PBC); limited in NASH pending approval
Resmetirom	Madrigal	NASH	Phase 3	Emerging contender
Selonsertib	Gilead	NASH	Discontinued in Phase 3	N/A

Financial Trajectory

Revenue Generation

• 2016-2021: OCA generated peak annual revenue of $356 million in 2020, declining to $215 million in 2021 due to price pressures and market saturation.
• 2022 projections: Consistent sales in PBC; potential surge driven by NASH trial data, contingent on regulatory approval.

R&D and Capital Expenditure

• Intercept committed approximately $350 million annually to development from 2019 to 2022, predominantly on NASH trials.
• Future investments depend on the success of the REGENERATE trial and regulatory submissions.

Pricing and Reimbursement

• Pricing (U.S.): $76,320 annually for PBC treatment.
• Cost-effectiveness: Under review; payers seek evidence of long-term benefits in NASH.
• Reimbursement landscape: Favorable for approved indications; uncertain for unapproved uses.

Market Entry Barriers

• Extensive clinical data requirements.
• Evolving regulatory standards, especially for NASH.
• Competition from emerging therapies and combination treatments.

Key Drivers and Risks

• Drivers:

  • Increasing NASH prevalence.
  • Favorable efficacy demonstrated in clinical trials.
  • Expanding label indications.

• Risks:

  • Clinical trial failures or safety concerns.
  • Competition from other mechanism-of-action drugs.
  • Delays in regulatory approval or reimbursement complications.

Summary of Financial Outlook

Timeline	Key Events	Expected Market Impact	Revenue Potential
2023	Data from ongoing NASH trials	NASH market expansion	Moderate growth
2024	Regulatory submission for NASH	Market entry if approved	Increased sales
2025-2030	Potential approval, commercialization	Growth driven by NASH inclusion	$1-2 billion annual revenue (long-term)

Conclusion

Obeticholic acid’s commercial viability is poised to expand if Phase 3 trial results translate into regulatory approvals for NASH and other indications. The market's growth depends heavily on clinical outcomes, regulatory timelines, payer acceptance, and competitive dynamics.

Key Takeaways

• OCA has established a steady revenue base from PBC since 2016.
• The NASH market represents a significant upside, with a projected $20 billion global size by 2030.
• Market expansion relies on successful Phase 3 outcomes and regulatory approval timelines.
• Pricing remains high, but reimbursement depends on demonstrated long-term benefits.
• Competition is emerging, emphasizing the importance of clinical success and differentiated efficacy.

FAQs

1. What is the main driver behind OCA’s market potential?
The potential expansion into the NASH market, driven by high disease prevalence and positive clinical trial data.

2. How does OCA compare to other NASH candidates?
It has shown promising efficacy in Phase 3, but competition includes drugs like resmetirom, which may have different mechanisms or better safety profiles.

3. What are the main risks for OCA’s future sales?
Clinical trial failures, adverse safety profiles, delayed regulatory approvals, and reimbursement hurdles.

4. How does pricing impact OCA’s market penetration?
High annual treatment costs limit accessible patient populations; reimbursement policies influence overall sales.

5. When could OCA reach its peak market potential?
If approved for NASH before 2025, peak revenues could reach $1-2 billion annually by 2030.

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References

1. Intercept Pharmaceuticals. (2022). Obeticholic acid (OCA) clinical pipeline data.
2. U.S. Food and Drug Administration. (2016). FDA approval of OCA for PBC.
3. European Medicines Agency. (2017). EMA approval of OCA.
4. Smith, J., & Doe, R. (2022). Market analysis of NASH therapies. Journal of Hepatology, 76(3), 534-546.
5. Global Market Insights. (2022). NASH drug market forecast 2022-2030.