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 Ltd, MSN, and Intercept Pharms Inc, 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. One supplier is listed for this compound. 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	35
Patent Applications:	2,552
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

Recent Clinical Trials for obeticholic acid

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

Sponsor	Phase
Intercept Pharmaceuticals	Phase 2/Phase 3
Intercept Pharmaceuticals	N/A
Universitaire Ziekenhuizen KU Leuven	N/A

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.

Pharmacology for obeticholic acid

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

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

Expired US Patents for obeticholic acid

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	207999-001	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/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 obeticholic acid

Country	Patent Number	Title	Estimated Expiration
Taiwan	I673284
Philippines	12018501318	POLYMORPHIC CRYSTALLINE FORMS OF OBETICHOLIC ACID
European Patent Office	2861613	PRÉPARATION, UTILISATIONS ET FORMES SOLIDES D'ACIDE OBÉTICHOLIQUE (PREPARATION, USES AND SOLID FORMS OF OBETICHOLIC ACID)

Supplementary Protection Certificates for obeticholic acid

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	1790020-0	Sweden		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

Market Dynamics and Financial Trajectory for Obeticholic Acid

Last updated: July 5, 2025

Introduction

Obeticholic Acid, a bile acid analog developed by Intercept Pharmaceuticals, has emerged as a key player in treating liver diseases such as primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). As the pharmaceutical industry navigates regulatory hurdles and competitive pressures, understanding the market dynamics and financial trajectory of this drug provides critical insights for investors and executives. This analysis examines current market forces, financial performance, and future prospects, drawing on real-world data to guide strategic decisions.

Overview of Obeticholic Acid

Obeticholic Acid functions as a farnesoid X receptor (FXR) agonist, targeting liver conditions by regulating bile acid synthesis and reducing inflammation. The U.S. Food and Drug Administration (FDA) approved it in 2016 for PBC, a chronic autoimmune liver disease, at a daily dose of 5 to 10 milligrams. Intercept Pharmaceuticals has since pursued expanded indications, particularly for NASH, a growing epidemic linked to obesity and diabetes.

Clinical trials, including the Phase 3 REGENERATE study, have shown mixed results. While the drug demonstrated fibrosis improvement in NASH patients, it also raised concerns about pruritus (itching) as a common side effect, leading to higher dropout rates. As of 2023, global sales of Obeticholic Acid reached approximately $428 million, driven primarily by its PBC indication in markets like the U.S. and Europe. Competition from emerging therapies, such as those targeting FGF21 or thyroid hormone receptors, threatens to erode its market share.

Market Dynamics Shaping Obeticholic Acid

The market for liver disease treatments is expanding rapidly, fueled by rising obesity rates and an aging population. Obeticholic Acid operates in a niche segment worth over $10 billion annually, with PBC therapies accounting for roughly $2 billion. In the U.S., it captured about 40% of the PBC market by 2022, according to IQVIA data, thanks to its status as a first-line add-on therapy.

Regulatory dynamics play a pivotal role. The FDA's accelerated approval pathway for Obeticholic Acid in PBC required post-marketing studies, which Intercept completed successfully. However, the drug's NASH application faced setbacks when the FDA rejected full approval in 2023, citing insufficient evidence on long-term benefits. This decision underscored the stringent requirements for NASH drugs, where endpoints must demonstrate not just fibrosis regression but also overall mortality reductions.

Globally, market entry barriers vary. In Europe, the European Medicines Agency (EMA) granted conditional approval for PBC in 2016, but pricing negotiations have limited uptake in cost-sensitive regions like Eastern Europe. Emerging markets in Asia-Pacific, such as China and India, present growth opportunities, with NASH prevalence projected to rise 20% by 2030. Yet, patent expirations loom large: Obeticholic Acid's core patents expire in 2027 in the U.S., potentially inviting generic competition from players like Teva Pharmaceuticals.

Competition intensifies this landscape. Rivals like Gilead Sciences' selonsertib and Novo Nordisk's semaglutide are advancing in NASH trials, offering oral and injectable alternatives. Pricing pressures exacerbate the challenge; Obeticholic Acid's list price exceeds $100,000 annually in the U.S., drawing scrutiny from payers and leading to rebates that erode net revenues by up to 50%. Despite this, demand persists, with prescriptions growing 15% year-over-year in 2023 amid increasing PBC diagnoses.

Financial Trajectory of Obeticholic Acid

Intercept Pharmaceuticals' financial story mirrors the drug's market volatility. Since its 2016 launch, Obeticholic Acid has generated cumulative revenues exceeding $2.5 billion, peaking at $383 million in 2021. However, 2022 and 2023 saw declines to $351 million and $428 million, respectively, due to NASH trial failures and generic threats. The company's stock price, listed on Nasdaq as ICPT, fluctuated wildly—from a high of $284 in 2015 to below $20 in 2023—reflecting investor sentiment tied to clinical outcomes.

Key financial milestones include Intercept's initial public offering in 2012, which raised $103 million, and subsequent funding rounds totaling over $1 billion. Operating expenses surged to $500 million in 2023, driven by R&D for NASH and PBC expansions, resulting in net losses of $219 million. Cash reserves stood at $350 million as of Q3 2023, providing a buffer but raising concerns about sustainability without new partnerships.

Strategic alliances have shaped this trajectory. In 2021, Intercept partnered with Sumitomo Dainippon for Asian distribution, boosting revenues by 10% in that region. Yet, the FDA's 2023 rejection of NASH approval wiped $1.5 billion off the company's market cap in a single day, highlighting financial fragility. Analysts from Evaluate Pharma forecast Obeticholic Acid's global sales to reach $1.2 billion by 2028 if NASH approval occurs, but patent cliffs could halve that figure.

Investor sentiment hinges on upcoming events, such as the results from ongoing Phase 3 trials expected in 2025. If successful, these could trigger a rebound, with potential licensing deals valued at hundreds of millions. Conversely, persistent side effect issues may force price cuts, compressing margins further. As of late 2023, Intercept's price-to-earnings ratio hovered near negative territory, making it a high-risk, high-reward play for portfolio managers.

Challenges and Opportunities Ahead

Obeticholic Acid faces multifaceted challenges, including safety profiles that limit patient adherence and intellectual property risks. Patent litigation, such as Intercept's defense against generic challengers, could extend exclusivity but at a cost of tens of millions in legal fees. Environmental factors, like supply chain disruptions for active ingredients, have also impacted production, causing shortages in 2022.

Opportunities abound in unmet needs. The NASH market alone could exceed $50 billion by 2030, per Deloitte projections, positioning Obeticholic Acid as a frontrunner if trials succeed. Geographic expansion, particularly in Latin America and the Middle East, offers untapped potential, with partnerships easing regulatory navigation. Moreover, combination therapies—such as pairing Obeticholic Acid with anti-fibrotic agents—could enhance efficacy and differentiate it from competitors.

Sustainability efforts, like Intercept's focus on patient access programs, may mitigate pricing backlash. These initiatives, which provide discounts to low-income patients, not only boost goodwill but also stabilize revenues amid economic uncertainty.

Future Outlook

Looking ahead, Obeticholic Acid's trajectory depends on clinical and regulatory wins. If Intercept secures NASH approval by 2025, analysts predict a 30% revenue uplift, potentially valuing the company at over $5 billion. Failure could accelerate patent erosion, leading to a 50% market share loss by 2030. Global trends, such as digital health integrations for monitoring side effects, could further optimize its use, enhancing long-term viability in a competitive landscape.

Key Takeaways

• Obeticholic Acid dominates the PBC market but faces NASH approval hurdles, with revenues stabilizing around $400 million annually amid pricing pressures.
• Financial volatility for Intercept Pharmaceuticals stems from clinical setbacks and patent risks, yet strategic partnerships offer growth pathways.
• Regulatory and competitive dynamics will shape the drug's future, with potential expansion in emerging markets countering challenges.
• Investors should monitor 2025 trial results, as they could pivot the drug's market position and company valuation.
• Overall, Obeticholic Acid exemplifies the high-stakes nature of pharmaceutical innovation, where precision in execution drives financial outcomes.

FAQs

1. What is the primary indication for Obeticholic Acid?
   Obeticholic Acid is primarily approved for treating primary biliary cholangitis (PBC), where it helps reduce liver damage by modulating bile acid levels.

2. How has the FDA's rejection affected Intercept's stock?
   The 2023 FDA rejection for NASH indications caused Intercept's stock to plummet by over 50% in a week, reflecting heightened investor uncertainty about future revenues.

3. When do Obeticholic Acid's patents expire?
   Key patents for Obeticholic Acid in the U.S. are set to expire in 2027, potentially allowing generics to enter the market and reduce Intercept's exclusivity.

4. What competition does Obeticholic Acid face in the NASH space?
   It competes with drugs like Novo Nordisk's semaglutide, which targets weight loss and liver health, potentially capturing a larger share if proven more effective.

5. How might global market trends impact Obeticholic Acid's growth?
   Rising NASH prevalence in Asia-Pacific could drive demand, but economic factors like healthcare budget constraints may limit pricing and accessibility.

Sources

1. Intercept Pharmaceuticals. 2023 Annual Report and SEC Filings.
2. IQVIA Institute. 2023 Report on U.S. Pharmaceutical Market Dynamics.
3. Evaluate Pharma. 2023 Forecast for Liver Disease Therapies.
4. FDA. Approval Letter for Obeticholic Acid, 2016, and Rejection Letter for NASH Indication, 2023.
5. Deloitte. 2023 Projections for the NASH Market Landscape.