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. Eighteen 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:	18
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	100
Patent Applications:	7,248
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
Al-Azhar University	Phase 2/Phase 3
Ain Shams 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
Apotex Inc	LEFLUNOMIDE	leflunomide	TABLET;ORAL	077090-001	Sep 13, 2005	AB	RX	No	No
Alembic Pharms Ltd	LEFLUNOMIDE	leflunomide	TABLET;ORAL	091369-002	Nov 21, 2011	AB	RX	No	No
Aet Pharma	LEFLUNOMIDE	leflunomide	TABLET;ORAL	213497-001	May 10, 2021	AB	RX	No	No
Alembic Pharms Ltd	LEFLUNOMIDE	leflunomide	TABLET;ORAL	091369-001	Nov 21, 2011	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	020905-001	Sep 10, 1998
Sanofi Aventis Us	ARAVA	leflunomide	TABLET;ORAL	020905-002	Sep 10, 1998
Sanofi Aventis Us	ARAVA	leflunomide	TABLET;ORAL	020905-002	Sep 10, 1998
Sanofi Aventis Us	ARAVA	leflunomide	TABLET;ORAL	020905-003	Sep 10, 1998

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
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