ARAVA Drug Patent Profile

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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. Eighteen 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.

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Summary for ARAVA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	143
Patent Applications:	4,457
Drug Prices:	Drug price information for ARAVA
What excipients (inactive ingredients) are in ARAVA?	ARAVA excipients list
DailyMed Link:	ARAVA at DailyMed

Drug patent expirations by year for ARAVA

Pharmacology for ARAVA

Drug Class	Antirheumatic Agent

US Patents and Regulatory Information for ARAVA

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Glossary

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

Expired US Patents for ARAVA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	ARAVA	leflunomide	TABLET;ORAL	020905-001	Sep 10, 1998	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	ARAVA	leflunomide	TABLET;ORAL	020905-002	Sep 10, 1998	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	ARAVA	leflunomide	TABLET;ORAL	020905-002	Sep 10, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for ARAVA

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for ARAVA

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

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Country	Patent Number	Title	Estimated Expiration
Denmark	149886		⤷ Sign Up
Portugal	70596		⤷ Sign Up
Austria	96669		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Summary for ARAVA

Pharmacology for ARAVA

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