AUBAGIO Drug Patent Profile

When do Aubagio patents expire, and when can generic versions of Aubagio launch?

Aubagio is a drug marketed by Sanofi Aventis Us and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has eighty patent family members in forty-seven countries.

The generic ingredient in AUBAGIO is teriflunomide. There are nineteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the teriflunomide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aubagio

A generic version of AUBAGIO was approved as teriflunomide by TEVA PHARMS USA on September 4^th, 2018.

Summary for AUBAGIO

International Patents:	80
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	15
Patent Applications:	3,630
Drug Prices:	Drug price information for AUBAGIO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AUBAGIO
What excipients (inactive ingredients) are in AUBAGIO?	AUBAGIO excipients list
DailyMed Link:	AUBAGIO at DailyMed

See drug prices for AUBAGIO

Recent Clinical Trials for AUBAGIO

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

Sponsor	Phase
Beijing Friendship Hospital	Phase 2
Peking University Third Hospital	Phase 2
Chinese PLA General Hospital	Phase 2

See all AUBAGIO clinical trials

Pharmacology for AUBAGIO

Drug Class	Pyrimidine Synthesis Inhibitor
Mechanism of Action	Dihydroorotate Dehydrogenase Inhibitors

Paragraph IV (Patent) Challenges for AUBAGIO

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 AUBAGIO

AUBAGIO is protected by three US patents.

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	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012	AB	RX	Yes	No	8,802,735*PED				Y
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012	AB	RX	Yes	Yes	8,802,735*PED				Y
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012	AB	RX	Yes	No	6,794,410*PED				Y
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 AUBAGIO

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

EU/EMA Drug Approvals for AUBAGIO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Sanofi Winthrop Industrie	Aubagio	teriflunomide	EMEA/H/C/002514AUBAGIO 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/005960Teriflunomide 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/005962Teriflunomide 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 AUBAGIO

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

Country	Patent Number	Title	Estimated Expiration
Japan	H05208908	CHRONIC PAIR HOST TRANSPLANTATION PIECE DISEASE REMEDY
Honduras	2012000576
Ecuador	SP024244	USO DE (Z)-2-CYANO-3-HYDROXY-BUT-2-ENOIC ACID(4 ́-TRIFLUOROMETHYLPHENYL)-AMIDE PARA EL TRATAMIENTO DE LA ESCLEROSIS MÚLTIPLE
Spain	2625731

Supplementary Protection Certificates for AUBAGIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1381356	132014902231965	Italy		AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/838, 20130826;EU/1/13/838, 20130826
1381356	2014/004	Ireland		PRODUCT NAME: TERIFLUNOMIDE, ITS STEREOISOMER AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356	CA 2014 00005	Denmark		PRODUCT NAME: TERIFLUNOMID, DETS STEREOISOMER OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/13/838/001-005 20130826
1381356	2014C/008	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION

Market Dynamics and Financial Trajectory for AUBAGIO (Teriflunomide)

Last updated: February 19, 2026

What is the current market position of AUBAGIO?

AUBAGIO (teriflunomide) is an oral disease-modifying therapy for relapsing forms of multiple sclerosis (MS). Approved by the FDA in September 2012 and EMA in March 2013, AUBAGIO generated $262 million in global sales in 2022, marking its position as a significant player in the MS treatment landscape.

How does AUBAGIO compare to other MS therapies?

Drug	Year Approved	Administration	Market Share (2022)	Global Sales (2022)	Key Competitors
AUBAGIO (Teriflunomide)	2012 (FDA)	Oral	10%	$262M	Aubagio, Tecfidera, Gilenya
Tecfidera (Dimethyl Fumarate)	2013 (FDA)	Oral	25%	$2.4B	Gilenya, Mavenclad
Gilenya (Fingolimod)	2010 (FDA)	Oral	15%	$1.8B	Aubagio, Tecfidera

AUBAGIO holds a niche as a once-daily oral therapy with a safety profile favorable to some competitors, but it has lower market share compared to Tecfidera and Gilenya.

What is the revenue trend and growth outlook?

Year	Sales (Million USD)	Growth Rate (%)	Notes
2018	198	N/A	U.S. launches additional dosing info
2019	222	12%	Inclusion of new label updates
2020	250	13%	Pandemic impact mitigated
2021	255	2%	Market saturation
2022	262	2.7%	Steady growth, limited upside

Sales growth has slowed from double-digit increases earlier, reflecting market saturation and increased competition.

What factors influence AUBAGIO’s market performance?

Patent and exclusivity status

AUBAGIO’s primary patent expired in 2021 in the U.S., opening the market to generics. The remnant of patent protections includes secondary patents on formulations extending through 2025. Patent expirations could lead to price erosion and generic competition.

Regulatory and safety considerations

Recent safety updates and label revisions, including warnings on hepatotoxicity and teratogenicity, influence prescribing behaviors. The safety profile remains favorable relative to some competitors, helping maintain patient adoption.

Competition landscape

Gilenya and Tecfidera dominate the MS oral therapy market, holding combined market shares above 40%. Mavenclad (cladribine) entered as an alternative, with a different dosing schedule. The emerging pipeline and pipeline drugs like Vumerity (diroximel fumarate) threaten further market share.

What is the outlook for future sales?

Predictions point to stagnation or slight decline due to patent expiries, generic entry, and competitive pressure. Innovator sales could decrease by up to 20% over the next three years, unless Novartis invests in new formulations or indications.

Potential growth may come from expansion into secondary MS indications or combination therapies. The launch in emerging markets, where price sensitivity limits branded therapy penetration, offers limited incremental revenue.

How do patent expirations affect financial projections?

Year	Major Patent Expiry	Impact on Sales	Mitigation Strategies
2021	U.S. patent	Decline expected in U.S. sales	Diversify pipeline, cost controls
2025	Secondary patents	U.S. generics enter, sales erosion	Launch of new formulations, indications

Price erosion following patent expiry could result in a 30-50% decrease in sales in affected markets without new product launches.

Summary of financial trajectory

Metric	2022	2023 Estimate	2024 Projection	Rationale
Revenue	$262M	$230M (-12%)	$200M (-13%)	Patent expiry, generics, competition
R&D expenses	$150M	$160M	$170M	Pipeline investments
Operating margin	45%	42%	40%	Margin pressure from generics

Key takeaways

• AUBAGIO remains a relevant oral MS therapy with stable sales but faces challenges from patent expiration and increasing generic competition.
• Market share will likely decline unless new indications, formulations, or pipeline assets compensate.
• The competitive landscape favors drugs with multi-mechanistic approaches and shorter dosing regimens.
• Sales are expected to decline in the near term, with potential stabilization if new pipeline assets materialize.
• Strategic focus on geographic expansion and pipeline diversification remains critical for sustained revenue.

FAQs

1. How long will AUBAGIO retain patent exclusivity?
Patent protection in the U.S. expired in 2021, with secondary patents extending into 2025. Generic entry is expected to significantly impact sales post-2021.

2. What are the main competitors to AUBAGIO?
Gilenya (fingolimod), Tecfidera (dimethyl fumarate), and Mavenclad (cladribine) are the primary competitors, holding larger market shares.

3. Will AUBAGIO’s sales recover post-patent expiry?
Sales are unlikely to recover without new formulations, indications, or strategic marketing, due to generic competition and market saturation.

4. How significant is pipeline activity for AUBAGIO’s future?
AUBAGIO’s pipeline includes potential new formulations and secondary MS indications. Success here could mitigate revenue declines.

5. What regulatory challenges could impact AUBAGIO?
Monitoring safety label updates and post-marketing surveillance is critical, as safety concerns could influence marketability.

---

Citations

[1] Novartis. (2022). AUBAGIO (teriflunomide) global sales report.
[2] U.S. Food and Drug Administration. (2012). AUBAGIO approval documents.
[3] EMA. (2013). AUBAGIO summary of product characteristics.
[4] Pharmaprojects. (2023). MS drug pipeline overview.