ARAVA Drug Patent Profile

When do Arava patents expire, and what generic alternatives are available?

Arava is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in ARAVA is leflunomide. There are seven drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the leflunomide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Arava

A generic version of ARAVA was approved as leflunomide by APOTEX INC on September 13^th, 2005.

Summary for ARAVA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	143
Patent Applications:	4,432
Drug Prices:	Drug price information for ARAVA
What excipients (inactive ingredients) are in ARAVA?	ARAVA excipients list
DailyMed Link:	ARAVA at DailyMed

See drug prices for ARAVA

Pharmacology for ARAVA

Drug Class

Antirheumatic Agent

US Patents and Regulatory Information for ARAVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	ARAVA	leflunomide	TABLET;ORAL	020905-001	Sep 10, 1998	AB	RX	Yes	No
Sanofi Aventis Us	ARAVA	leflunomide	TABLET;ORAL	020905-002	Sep 10, 1998	AB	RX	Yes	Yes
Sanofi Aventis Us	ARAVA	leflunomide	TABLET;ORAL	020905-003	Sep 10, 1998		RX	Yes	Yes

Expired US Patents for ARAVA

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
Sanofi Aventis Us	ARAVA	leflunomide	TABLET;ORAL	020905-003	Sep 10, 1998	4,284,786
Sanofi Aventis Us	ARAVA	leflunomide	TABLET;ORAL	020905-002	Sep 10, 1998	5,679,709
Sanofi Aventis Us	ARAVA	leflunomide	TABLET;ORAL	020905-002	Sep 10, 1998	4,284,786
Sanofi Aventis Us	ARAVA	leflunomide	TABLET;ORAL	020905-001	Sep 10, 1998	5,679,709

EU/EMA Drug Approvals for ARAVA

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
Sanofi-aventis Deutschland GmbH	Arava	leflunomide	EMEA/H/C/000235 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	1999-09-02
Teva B.V.	Repso	leflunomide	EMEA/H/C/001222 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.	Withdrawn	yes	no	no	2011-03-14
Teva Pharma B.V.	Leflunomide Teva	leflunomide	EMEA/H/C/002356 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.	Withdrawn	yes	no	no	2011-03-10

International Patents for ARAVA

See the table below for patents covering ARAVA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	588629
Japan	H0729918
European Patent Office	0013376	ISOXAZOLE DERIVATIVE, PROCESS FOR ITS PREPARATION AND COMPOSITION CONTAINING IT
Australia	529341
Finland	793899
Egypt	13926	AN ISOXAZOLE DERIVATIVES PROCESSES FOR ITS PREPARATION COMPOSITIONS CONTAINING IT AND ITS USE FOR COMBATING RHEUMATISM
Philippines	16627	AN ISOXAZOLE DERIVATIVE,COMPOSITION CONTAINING IT,AND ITS METHOD OF USE

ARAVA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ARAVA (Leflunomide)

Overview of ARAVA

ARAVA, or leflunomide, is a disease-modifying antirheumatic drug (DMARD) used in the treatment of rheumatoid arthritis (RA). It is known for its efficacy in reducing signs and symptoms of RA, as well as inhibiting structural damage to the joints[5].

Market Size and Growth of Rheumatoid Arthritis Drugs

The global rheumatoid arthritis drugs market, within which ARAVA operates, is projected to experience significant growth. By 2031, this market is estimated to reach $53.1 billion, growing at a compound annual growth rate (CAGR) of 5.6% from 2024 to 2031[1].

Segment Analysis

DMARDs Segment

ARAVA falls under the category of DMARDs, which are traditional synthetic drugs used to treat RA. While the market is increasingly dominated by biologics and JAK inhibitors, DMARDs like ARAVA continue to play a crucial role due to their established efficacy and lower cost compared to biologic agents.

Geographic Distribution

The North American market, particularly the United States, is a significant segment for RA drugs, including ARAVA. This region is expected to witness the strongest growth rate due to the high prevalence of RA and increasing annual treatment costs[1].

Financial Trajectory

Current Market Value

As of 2023, the global rheumatoid arthritis drugs market was valued at approximately $17.87 billion. This figure includes the contribution of various drug classes, including DMARDs like ARAVA[4].

Projected Growth

The market is expected to grow to around $27.38 billion by 2033, with a CAGR of 4.6% between 2023 and 2033. This growth is driven by an increasing RA population, greater awareness of effective treatments, and increased healthcare spending[4].

Competitive Landscape

Biopharmaceutical Companies

The rheumatoid arthritis drugs market is highly competitive, with biopharmaceutical companies holding a significant share. While ARAVA is an established drug, the market is seeing the introduction of new biologic drugs and JAK inhibitors, which could impact the market share of traditional DMARDs[3].

Generic and Branded Drugs

ARAVA, being a branded drug, faces competition from generic versions of DMARDs. However, its efficacy and long-term safety data help it maintain a position in the market. Biopharmaceutical companies are focusing on creating unique chemical entities and innovative compounds to solidify their market foothold[3].

Challenges and Opportunities

Safety and Efficacy

ARAVA has demonstrated significant efficacy in clinical trials, showing a reduction in signs and symptoms of RA and inhibition of structural damage. However, like other RA drugs, it comes with potential side effects and interactions, such as increased levels when administered with rifampin[5].

Regulatory Environment

The regulatory environment can impact the financial trajectory of ARAVA. For instance, changes in Medicare coverage, such as proposals to move drugs from Part B to Part D, could affect out-of-pocket costs for patients and access to the drug[2].

Access and Affordability

Medicare Coverage

Patients covered under Medicare, particularly those under Part D, often face higher out-of-pocket costs for RA drugs compared to those covered under Part B. This can affect the affordability and access to drugs like ARAVA for seniors[2].

Biosimilars and Generics

The launch of biosimilars for biologic RA drugs and the availability of generic versions of DMARDs can reduce treatment costs and increase access. However, this also poses a competitive challenge to branded drugs like ARAVA[1].

Key Takeaways

• Market Growth: The global rheumatoid arthritis drugs market is expected to grow significantly, reaching $53.1 billion by 2031.
• Segment Contribution: DMARDs like ARAVA continue to be important despite the dominance of biologics and JAK inhibitors.
• Geographic Focus: North America, particularly the U.S., is a key market due to high RA prevalence and increasing treatment costs.
• Competitive Landscape: The market is competitive with biopharmaceutical companies introducing new drugs, and generic versions posing a challenge to branded drugs.
• Regulatory and Access Issues: Changes in Medicare coverage and the launch of biosimilars can impact the financial trajectory and patient access to ARAVA.

FAQs

1. What is the projected growth rate of the global rheumatoid arthritis drugs market?

   • The global rheumatoid arthritis drugs market is expected to grow at a CAGR of 5.6% from 2024 to 2031[1].

2. How does ARAVA fit into the treatment landscape of rheumatoid arthritis?

   • ARAVA is a DMARD that reduces signs and symptoms of RA and inhibits structural damage, playing a crucial role alongside biologics and JAK inhibitors[5].

3. What are the main challenges facing ARAVA in the market?

   • ARAVA faces competition from new biologic drugs, JAK inhibitors, and generic versions, as well as regulatory changes that could affect patient access and affordability[1][3].

4. How does Medicare coverage impact the cost of ARAVA for patients?

   • Patients under Medicare Part D often pay higher out-of-pocket costs for RA drugs, including ARAVA, compared to those under Part B[2].

5. What is the impact of biosimilars on the market for branded RA drugs like ARAVA?

   • The launch of biosimilars can reduce treatment costs and increase access but also poses a competitive challenge to branded drugs like ARAVA[1].

Sources

1. Global Rheumatoid Arthritis Drugs Market $53.1 Billion by 2031 - iHealthcareAnalyst
2. Rheumatoid Arthritis Patients Could Face Access Barriers Under Proposal to Address Drug Prices - Avalere
3. Rheumatoid Arthritis Drugs Market Size to Worth USD 27.38 Bn by 2033 - GlobeNewswire
4. Rheumatoid Arthritis Drugs Market Size and Companies Report (2024) - Towards Healthcare
5. ARAVA® Tablets (leflunomide) 10 mg, 20 mg, 100 mg Rx only - FDA Label[5]