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:	1,162
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
Universitaire Ziekenhuizen KU Leuven	N/A
Intercept Pharmaceuticals	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	10,758,549
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016		RX	Yes	Yes	10,047,117
Lupin Ltd	OBETICHOLIC ACID	obeticholic acid	TABLET;ORAL	214980-002	May 30, 2023		DISCN	No	No
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016		RX	Yes	No	9,238,673		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	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
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016	8,058,267

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
Japan	2018184443	オベチコール酸の調製、使用および固体形態 (PREPARATION, USE AND SOLID FORM OF OBETICHOLIC ACID)
Canada	3009149	FORMES CRISTALLINES POLYMORPHES DE L'ACIDE OBETICHOLIQUE (POLYMORPHIC CRYSTALLINE FORMS OF OBETICHOLIC ACID)
Norway	2017022
China	107531742

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	23/2017	Austria		PRODUCT NAME: OBETICHOLSAEURE, DESSEN PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE ODER AMINOSAEURE-KONJUGATE; REGISTRATION NO/DATE: EU/1/16/1139 20161212
1392714	300877	Netherlands		PRODUCT NAME: OBETICHOLZUUR; REGISTRATION 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

Obeticholic acid Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Obeticholic Acid

Introduction

Obeticholic acid (OCA) is a promising therapeutic agent primarily used in the treatment of various liver diseases, including primary biliary cholangitis (PBC) and non-alcoholic steatohepatitis (NASH). The market for OCA is experiencing significant growth, driven by several key factors.

Market Size and Growth Projections

The global obeticholic acid market was valued at USD 1.1 billion in 2023 and is projected to reach USD 2.7 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 11.8% from 2024 to 2031[1].

Key Drivers of Market Growth

Increasing Prevalence of Liver Diseases

The rising prevalence of liver-related disorders, such as NASH and PBC, is a major driver of the OCA market. These conditions are becoming more common, leading to an increased demand for effective treatments[1].

Efficacy in Managing Chronic Liver Conditions

OCA has demonstrated significant efficacy in managing chronic liver conditions, particularly in patients who do not respond adequately to first-line treatments like ursodeoxycholic acid (UDCA). This efficacy is a crucial factor in driving market growth[1][5].

Regulatory Approvals and Clinical Achievements

Positive clinical trial outcomes and regulatory approvals have bolstered consumer trust and further propelled the market forward. The FDA approval of OCA for PBC treatment is a notable example of such regulatory support[1][5].

Research and Development

Continuous research into the wider medicinal applications of OCA and increasing R&D spending are also contributing to the market's expansion. New therapeutic uses and improved formulations are expected to enhance market dynamics[1].

Market Segmentation

The OCA market is segmented based on several criteria:

Application

• Liver Diseases: OCA is used to treat various liver diseases, including PBC and NASH.
• Cholestasis: It is also effective in managing cholestasis, a condition where bile flow is reduced or blocked.
• Combination Products: OCA is often used in combination with other drugs, such as UDCA, to enhance treatment outcomes[1].

Product Forms

• Tablets: The most common form of OCA administration.
• Oral Solutions: Used for patients who have difficulty swallowing tablets.
• Extended-Release Tablets: Designed to release the drug slowly over a longer period[1].

Geographical Regions

The market is analyzed across various geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each region has its own growth trajectory based on local healthcare infrastructure, regulatory environments, and disease prevalence[1][3].

Cost-Effectiveness and Financial Considerations

Cost-Effectiveness Analysis

Studies have shown that while OCA significantly improves long-term outcomes for PBC patients, its current pricing makes it less cost-effective. For instance, a study indicated that the lifetime cost of PBC treatment with OCA plus UDCA could increase to $902,000, resulting in an incremental cost-effectiveness ratio of $473,400 per quality-adjusted life year (QALY) gained. To be cost-effective, the annual price of OCA would need to be below $18,450[5].

Pricing and Reimbursement

The high cost of OCA is a significant factor in its financial trajectory. The annual price of $69,350 per patient makes it a costly treatment option. However, patient access schemes and negotiations with healthcare providers can help mitigate these costs[2][5].

Competitive Landscape

The OCA market features several key players, including Intercept Pharmaceuticals Inc., GlaxoSmithKline plc, and Teva Pharmaceutical Industries Ltd. These companies are involved in various stages of the market, from manufacturing to distribution, and play a crucial role in shaping market dynamics[3][4].

API Market

The active pharmaceutical ingredient (API) market for OCA is also growing, with major players such as Solara Active Pharma Sciences Ltd, Biophore India Pharmaceuticals Pvt Ltd, and Alembic Pharmaceuticals Ltd. The API market was valued at USD 350 million in 2023 and is forecast to reach USD 503.2 million by 2030, growing at a CAGR of 5.4%[4].

Challenges and Opportunities

Challenges

• High Cost: The high cost of OCA is a significant barrier to widespread adoption.
• Regulatory Hurdles: Regulatory approvals and pricing negotiations can be complex and time-consuming.
• Competition: The presence of other treatments, such as UDCA, can pose competition to OCA[2][5].

Opportunities

• Expanding Therapeutic Applications: Continuous research into new therapeutic uses of OCA can expand its market.
• Increasing Awareness: Rising awareness about liver diseases and the availability of effective treatments can drive demand.
• Emerging Markets: Growth in healthcare infrastructure in emerging markets presents new opportunities for OCA[1][3].

Conclusion

The market for obeticholic acid is poised for significant growth driven by its efficacy in treating chronic liver conditions, increasing prevalence of liver diseases, and ongoing research into new therapeutic applications. While the high cost of OCA presents a challenge, its long-term benefits and potential for cost-effectiveness with adjusted pricing make it a valuable treatment option.

Key Takeaways

• The global obeticholic acid market is projected to reach USD 2.7 billion by 2031.
• OCA is highly effective in managing chronic liver conditions like NASH and PBC.
• The market is driven by increasing disease prevalence, regulatory approvals, and ongoing R&D.
• High cost is a significant barrier, but adjusted pricing could improve cost-effectiveness.
• The API market for OCA is also growing, with a forecasted value of USD 503.2 million by 2030.

FAQs

What is the current market size of the obeticholic acid market?

The obeticholic acid market was valued at USD 1.1 billion in 2023[1].

What is the projected growth rate of the obeticholic acid market?

The market is expected to grow at a CAGR of 11.8% from 2024 to 2031[1].

What are the primary applications of obeticholic acid?

OCA is primarily used to treat liver diseases such as PBC and NASH, as well as cholestasis[1].

How cost-effective is obeticholic acid?

OCA is not currently cost-effective at its annual price of $69,350, but pricing below $18,450 per year could make it cost-effective[5].

Who are the key players in the obeticholic acid market?

Key players include Intercept Pharmaceuticals Inc., GlaxoSmithKline plc, and Teva Pharmaceutical Industries Ltd[3][4].

Sources

1. Market Research Intellect - Obeticholic Acid Market Size, Share & Global Report [2031]
2. NICE - Obeticholic acid for treating primary biliary cholangitis
3. Market Research Intellect - Primary Biliary Cirrhosis Drug Sales Market Size, Scope And ...
4. Valuates Reports - Obeticholic Acid API - Market Size
5. PubMed - Long-term clinical impact and cost-effectiveness of obeticholic acid ...