Teriflunomide - Generic Drug Details

What are the generic drug sources for teriflunomide and what is the scope of patent protection?

Teriflunomide is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Accord Hlthcare, Alembic, Amneal Pharms Co, Apotex, Aurobindo Pharma, Biocon Pharma, Breckenridge, Concord Biotech Ltd, Glenmark Speclt, Hetero Labs Ltd V, MSN, Mylan, Natco, Sandoz, Sola Pharms, Teva Pharms Usa, Torrent, Watson Labs Teva, and Zydus Pharms, and is included in twenty NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Teriflunomide has seventy-nine patent family members in forty-six countries.

There are nineteen drug master file entries for teriflunomide. Nineteen suppliers are listed for this compound.

Summary for teriflunomide

International Patents:	79
US Patents:	3
Tradenames:	2
Applicants:	20
NDAs:	20
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	55
Patent Applications:	4,449
Drug Prices:	Drug price trends for teriflunomide
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for teriflunomide
What excipients (inactive ingredients) are in teriflunomide?	teriflunomide excipients list
DailyMed Link:	teriflunomide at DailyMed

See drug prices for teriflunomide

Recent Clinical Trials for teriflunomide

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

Sponsor	Phase
Beijing Tsinghua Changgeng Hospital	Phase 2
Beijing Friendship Hospital	Phase 2
Peking University Third Hospital	Phase 2

See all teriflunomide clinical trials

Pharmacology for teriflunomide

Drug Class	Pyrimidine Synthesis Inhibitor
Mechanism of Action	Dihydroorotate Dehydrogenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for teriflunomide

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

L04AK	Dihydroorotate dehydrogenase (DHODH) inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for TERIFLUNOMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AUBAGIO	Tablets	teriflunomide	7 mg and 14 mg	202992	21	2016-09-12

US Patents and Regulatory Information for teriflunomide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms Co	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209613-001	Sep 28, 2018		DISCN	No	No
Sola Pharms	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209677-002	Sep 28, 2023	AB	RX	No	No
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012	AB	RX	Yes	No	9,186,346*PED				Y

Expired US Patents for teriflunomide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012	5,459,163
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012	5,459,163
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012	5,679,709

EU/EMA Drug Approvals for teriflunomide

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Sanofi Winthrop Industrie	Aubagio	teriflunomide	EMEA/H/C/002514 AUBAGIO is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established).	Authorised	no	no	no	2013-08-26
Accord Healthcare S.L.U.	Teriflunomide Accord	teriflunomide	EMEA/H/C/005960 Teriflunomide Accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established).	Authorised	yes	no	no	2022-11-09
Mylan Pharmaceuticals Limited	Teriflunomide Mylan	teriflunomide	EMEA/H/C/005962 Teriflunomide Mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 of the SmPC for important information on the population for which efficacy has been established).	Authorised	yes	no	no	2022-11-09

International Patents for teriflunomide

Country	Patent Number	Title	Estimated Expiration
Honduras	2012000576	FORMULACIONES EN COMPRIMIDO DE LA (4-TRIFLUOROMETILFENIL)AMIDA DEL ACIDO (Z)-2-CIANO-3-HIDROXIBUT-2-ENOICO CON ESTABILIDAD MEJORADA
Hong Kong	1206244	'- 穩定性提高的 -氰基- -羥基-丁- -烯酸- '-三氟甲基苯基 -酰胺片劑製劑 ((Z)-2-CYANO-3-HYDROXY-BUT-2-ENOIC ACID-(4-TRIFLUORMETHYLPHENYL)- AMIDE TABLET FORMULATIONS WITH IMPROVED STABILITY (Z)-2--3---2--(4-)-)
Japan	2013505213

Supplementary Protection Certificates for teriflunomide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1381356	486	Finland
1381356	PA2014004	Lithuania		PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356	C 2014 006	Romania		PRODUCT NAME: TERIFLUNOMIDA, STEREOIZOMERUL SAU SI SARURILE FARMACEUTICACCEPTABILE ALEACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/838/001, EU/1/13/838/002, EU/1/13/838/003, EU/1/13/838/004, EU/1/13/838/005; DATE OF NATIONAL AUTHORISATION: 20130826; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/838/001, EU/1/13/838/002, EU/1/13/838/003, EU/1/13/838/004, EU/1/13/838/005; DATE OF FIRST AUTHORISATION IN EEA: 20130826

Market Dynamics and Financial Trajectory of Teriflunomide

Introduction to Teriflunomide

Teriflunomide, an active metabolite of leflunomide, is a prescription medication primarily used for the treatment of relapsing forms of multiple sclerosis (MS) in adults. It acts by inhibiting pyrimidine de novo synthesis through the blockade of the enzyme dihydroorotate dehydrogenase, thereby exerting its immunomodulatory effects[1][3].

Market Drivers

The teriflunomide market is driven by several key factors:

Rising Incidence of Chronic Disorders

The increasing prevalence of multiple sclerosis and other chronic autoimmune diseases is a significant driver. Approximately 1 million people in the U.S. and 2.3 million globally live with MS, with around 200 new cases diagnosed every week in the U.S.[4].

Growing R&D Investments

Pharmaceutical companies are investing heavily in research and development to fill Abbreviated New Drug Applications (ANDAs) and develop novel therapies, which is expected to fuel market growth[1].

Demand for Immunomodulatory Agents

The growing demand for immunomodulatory agents, particularly in the treatment of MS and other autoimmune diseases, is another key driver[1].

Market Restraints

Despite the positive drivers, there are several restraints that could impact the market:

Stringent Regulations

Stringent regulations by drug regulatory bodies can slow down the approval process and affect market growth. For instance, the Therapeutic Goods Administration (TGA) in Australia emphasizes the need for clear labelling and careful monitoring of side effects[3].

Potential Side Effects

Teriflunomide is associated with side effects such as body aches, fever, tiredness, and vomiting, which can deter some patients and healthcare providers. Neutropenia and skin reactions are also concerns, especially at higher doses[1][3].

Market Segmentation

The teriflunomide market is segmented based on several criteria:

By Type

The market is segmented into tablets and powders, catering to different patient needs and preferences[1][4].

By Application

The primary applications include immunosuppression, cancer treatment, multiple sclerosis, and other indications. Multiple sclerosis remains the most significant application area[1][4].

By End-User

The market is split into hospitals, clinics, and other healthcare settings, reflecting the diverse points of care where teriflunomide is administered[4].

Regional Framework

The global teriflunomide market is analyzed across several key regions:

North America

This region is expected to capture a major share of the global market due to the high prevalence of multiple sclerosis and increasing cases of cancer. The U.S. alone accounts for a significant portion of MS diagnoses and treatments[4].

Europe

Europe is another significant market, driven by the high incidence of autoimmune diseases and the presence of major pharmaceutical companies[1].

Asia-Pacific (APAC)

The APAC region is growing rapidly due to increasing healthcare expenditure and a rising awareness of MS and other autoimmune diseases[1].

Middle East and Africa (MEA) and South & Central America

These regions also present opportunities for growth, although at a slower pace compared to North America and Europe[1].

Financial Trajectory

Market Size and Growth

The teriflunomide market is forecasted to grow at a significant Compound Annual Growth Rate (CAGR) from 2023 to 2031. The market size is expected to increase substantially, driven by the factors mentioned above[1].

Revenue Forecast

The revenue forecast indicates a steady increase, with North America and Europe contributing significantly to the global revenue. The market is expected to reach several hundred million dollars by 2031[1].

Cost-Effectiveness Analysis

A cost-effectiveness analysis comparing teriflunomide with dimethyl fumarate for the treatment of relapsing-remitting multiple sclerosis (RRMS) in Italy showed that dimethyl fumarate is generally more cost-effective. However, this does not diminish the financial viability of teriflunomide, as it remains a crucial treatment option for many patients.

• Quality-Adjusted Life Years (QALYs): Dimethyl fumarate was found to offer more QALYs compared to teriflunomide, but teriflunomide still provides significant health benefits[2].

• Cost Savings: The analysis highlighted that dimethyl fumarate results in cost savings related to relapses, inpatient care, informal care, and long-term absence/early retirement. However, teriflunomide's cost structure remains competitive in the market[2].

Key Players

The global teriflunomide market is highly fragmented with several key players:

• Sanofi Aventis: The primary sponsor and developer of teriflunomide, marketed under the brand name Aubagio[1][3].
• Genzyme Corporation: Another major player involved in the distribution and marketing of teriflunomide[1].
• Amneal Pharmaceuticals, Glenmark Pharmaceuticals, Msn Laboratories Private Limited, Alembic Pharmaceuticals, Natco, Sigma, and Aldrich: These companies also play significant roles in the manufacturing and distribution of teriflunomide[1].

Clinical Efficacy and Safety

Teriflunomide has demonstrated significant clinical efficacy in reducing the frequency of clinical exacerbations and delaying the accumulation of physical disability in patients with relapsing MS. A randomized clinical trial showed a 72% reduction in the risk of clinical MS in patients with radiologically isolated syndrome treated with teriflunomide compared to placebo[5].

Key Takeaways

• The teriflunomide market is driven by the rising incidence of MS and other autoimmune diseases.
• Growing R&D investments and demand for immunomodulatory agents are key drivers.
• Stringent regulations and potential side effects are restraints.
• The market is segmented by type, application, and end-user.
• North America and Europe are major regions contributing to the market growth.
• Teriflunomide remains a financially viable treatment option despite cost-effectiveness comparisons with other drugs.

Frequently Asked Questions (FAQs)

Q: What is teriflunomide primarily used for? A: Teriflunomide is primarily used for the treatment of relapsing forms of multiple sclerosis in adults.

Q: What are the key drivers of the teriflunomide market? A: The key drivers include the rising incidence of chronic disorders, growing R&D investments, and increasing demand for immunomodulatory agents.

Q: Which regions are expected to dominate the teriflunomide market? A: North America and Europe are expected to capture a major share of the global teriflunomide market.

Q: What are the potential side effects of teriflunomide? A: Potential side effects include body aches, fever, tiredness, vomiting, neutropenia, and skin reactions.

Q: How does teriflunomide compare to dimethyl fumarate in terms of cost-effectiveness? A: Dimethyl fumarate is generally more cost-effective than teriflunomide, but teriflunomide remains a crucial treatment option with significant health benefits[2].

Cited Sources

1. The Insight Partners - Teriflunomide Market Key Players Analysis 2031
2. Farmeconomia - Cost-Effectiveness of Dimethyl Fumarate Compared to Teriflunomide for Relapsing Remitting Multiple Sclerosis Patients in Italy
3. Therapeutic Goods Administration - Extract from the Clinical Evaluation Report for Teriflunomide
4. Biospace - Teriflunomide Market: Rising burden of cancer to drive the market
5. JAMA Neurology - Teriflunomide and Time to Clinical Multiple Sclerosis in Patients with Radiologically Isolated Syndrome

Last updated: 2024-12-17