LEFLUNOMIDE - Generic Drug Details

What are the generic drug sources for leflunomide and what is the scope of freedom to operate?

Leflunomide is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Abhai Llc, Aet Pharma, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma, Barr, Heritage, Lupin Ltd, Sandoz, Teva Pharms, Wanbang Biopharms, and Zydus Lifesciences, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for leflunomide. Seventeen suppliers are listed for this compound.

Summary for LEFLUNOMIDE

US Patents:	0
Tradenames:	2
Applicants:	13
NDAs:	13
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	100
Patent Applications:	7,755
Drug Prices:	Drug price trends for LEFLUNOMIDE
Drug Sales Revenues:	Drug sales revenues for LEFLUNOMIDE
What excipients (inactive ingredients) are in LEFLUNOMIDE?	LEFLUNOMIDE excipients list
DailyMed Link:	LEFLUNOMIDE at DailyMed

See drug prices for LEFLUNOMIDE

See drug sales revenues for LEFLUNOMIDE

Recent Clinical Trials for LEFLUNOMIDE

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

Sponsor	Phase
University Hospital, Basel, Switzerland	N/A
Ain Shams University	Phase 2/Phase 3
Misr International University	Phase 2/Phase 3

See all LEFLUNOMIDE clinical trials

Pharmacology for LEFLUNOMIDE

Drug Class

Antirheumatic Agent

Anatomical Therapeutic Chemical (ATC) Classes for LEFLUNOMIDE

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

US Patents and Regulatory Information for LEFLUNOMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Barr	LEFLUNOMIDE	leflunomide	TABLET;ORAL	077083-002	Sep 13, 2005		DISCN	No	No
Barr	LEFLUNOMIDE	leflunomide	TABLET;ORAL	077083-001	Sep 13, 2005		DISCN	No	No
Abhai Llc	LEFLUNOMIDE	leflunomide	TABLET;ORAL	212453-001	Jun 3, 2019	AB	RX	No	No

Expired US Patents for LEFLUNOMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	ARAVA	leflunomide	TABLET;ORAL	020905-002	Sep 10, 1998	4,351,841
Sanofi Aventis Us	ARAVA	leflunomide	TABLET;ORAL	020905-003	Sep 10, 1998	5,679,709
Sanofi Aventis Us	ARAVA	leflunomide	TABLET;ORAL	020905-001	Sep 10, 1998	4,284,786

EU/EMA Drug Approvals for LEFLUNOMIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Zentiva k.s.	Leflunomide Zentiva (previously Leflunomide Winthrop)	leflunomide	EMEA/H/C/001129 Leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD);active psoriatic arthritis.Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.	Authorised	no	no	no	2010-01-08
Ratiopharm GmbH	Leflunomide ratiopharm	leflunomide	EMEA/H/C/002035 Leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD);active psoriatic arthritis.Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.	Authorised	yes	no	no	2010-11-28
medac Gesellschaft für klinische Spezialpräparate mbH	Leflunomide medac	leflunomide	EMEA/H/C/001227 Leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD).Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions, therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.	Authorised	yes	no	no	2010-07-27

LEFLUNOMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Leflunomide

Introduction to Leflunomide

Leflunomide, commonly known by its brand name Arava, is a disease-modifying antirheumatic drug (DMARD) used to treat adult moderate to severe rheumatoid arthritis. It belongs to a class of medications that decrease joint damage and disability caused by rheumatoid arthritis.

Market Growth and Forecast

The global leflunomide market is projected to experience significant growth, with a forecasted market growth rate of 6.20% from 2022 to 2029. This growth is driven by several key factors, including the increasing prevalence of rheumatoid arthritis globally, advancements in research and development by pharmaceutical companies, and the rising demand for the drug due to an aging population[1].

Key Drivers of Market Growth

• Increasing Prevalence of Rheumatoid Arthritis: The global rise in rheumatoid arthritis cases is a major driver for the leflunomide market. As more people are diagnosed with this condition, the demand for effective treatments like leflunomide increases.
• Research and Development: Pharmaceutical companies are continuously enhancing leflunomide and developing new formulations, which accelerates market growth.
• Technological Advancements: The use of advanced technologies in drug development and manufacturing processes further boosts the market.
• Healthcare Expenditure and Government Support: Increased healthcare expenditure and supportive government legislation also contribute positively to the market growth[1].

Market Segmentation

The leflunomide market is segmented based on trade names (such as Arava, Lefumide, Arabloc, and others) and distribution channels (hospital pharmacy, retail pharmacy, online pharmacy). Geographically, the market is dominated by North America due to high awareness and adoption of treatments, while the Asia-Pacific region is expected to witness high growth due to its large target population[1].

Competitive Landscape

The leflunomide market is competitive, with major players including Pfizer Inc., Fresenius Kabi USA, Abbvie Inc., Novartis AG, Amgen Inc., Boehringer Ingelheim International GmbH, and others. These companies are focused on research and development, new market initiatives, and expanding their global presence[1].

Cost and Economic Analysis

Comparison with Methotrexate

Studies have shown that while leflunomide and methotrexate have similar therapeutic outcomes, the costs associated with leflunomide are significantly higher when drug acquisition and monitoring costs are included. For instance, a study found that the annual drug acquisition and monitoring costs for leflunomide were substantially higher than those for methotrexate[2].

Cost-Effectiveness Analysis

A 5-year cost-effectiveness analysis from a public payer's perspective indicated that adding leflunomide to a sequence of DMARDs increases the 5-year management costs but provides reasonable cost-effectiveness and cost utility. The cost-effectiveness ratio was estimated at $13,096 per additional year of response to treatment, and the cost-utility ratios were $54,229 and $71,988 per quality-adjusted life-year gained[3].

Comparison with Biosimilars

Recent studies have compared the cost-effectiveness of leflunomide with biosimilars like infliximab and adalimumab. The analysis suggested that biosimilar sequences are often more cost-effective than leflunomide, with incremental cost-effectiveness ratios below the willingness-to-pay threshold[4].

Factors Affecting Cost

• Treatment Plan and Insurance Coverage: The cost of leflunomide varies based on the treatment plan, insurance coverage, and the pharmacy used[5].
• Dosage and Supply: The quantity prescribed, such as a 90-day supply, can impact the cost. Additionally, using coupons or savings programs can reduce the cost[5].
• Pharmacy and Location: The cost can differ significantly depending on the pharmacy and location[5].

Challenges and Limitations

Despite the positive market outlook, there are challenges that could obstruct the growth of the leflunomide market. These include:

• Long Approval Process: The lengthy approval process for drugs can delay market entry and impact growth.
• Stringent Regulations: Strict regulatory requirements can pose challenges for market players[1].

Regional Market Dynamics

• North America: Dominates the leflunomide market due to high awareness and adoption of treatments.
• Asia-Pacific: Expected to witness high growth due to the large target population in the region[1].

Future Outlook

The leflunomide market is poised for continued growth driven by increasing demand, technological advancements, and supportive government policies. However, the market will need to navigate challenges such as high drug acquisition costs and stringent regulations.

Key Takeaways

• The global leflunomide market is expected to grow at a rate of 6.20% from 2022 to 2029.
• The market is driven by the increasing prevalence of rheumatoid arthritis, R&D advancements, and rising healthcare expenditure.
• Leflunomide is more expensive than methotrexate when drug acquisition and monitoring costs are included.
• Biosimilars may offer more cost-effective alternatives to leflunomide.
• Factors such as treatment plan, insurance coverage, and pharmacy used significantly affect the cost of leflunomide.

FAQs

Q: What is leflunomide used for? A: Leflunomide is used to treat adult moderate to severe rheumatoid arthritis.

Q: What are the key drivers of the leflunomide market growth? A: The key drivers include the increasing prevalence of rheumatoid arthritis, R&D advancements, technological advancements, and rising healthcare expenditure.

Q: How does the cost of leflunomide compare with methotrexate? A: Leflunomide is significantly more expensive than methotrexate when drug acquisition and monitoring costs are included.

Q: Are biosimilars a cost-effective alternative to leflunomide? A: Yes, biosimilars like infliximab and adalimumab can be more cost-effective than leflunomide in certain scenarios.

Q: What factors affect the cost of leflunomide? A: The cost of leflunomide is affected by factors such as treatment plan, insurance coverage, dosage, supply quantity, and the pharmacy used.

Citations

1. Data Bridge Market Research, "Global Leflunomide Market - Industry Trends and Forecast to 2029".
2. PubMed, "Economic comparison of leflunomide and methotrexate in patients with rheumatoid arthritis".
3. PubMed, "Cost effectiveness of adding leflunomide to a 5-year strategy of disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis".
4. JAMA Network Open, "Cost-Effectiveness of Biosimilars vs Leflunomide in Patients With Rheumatoid Arthritis".
5. Medical News Today, "Leflunomide cost 2024: Coupons and more".