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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AUBAGIO

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					Y
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012	AB	RX	Yes	Yes					Y
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012	AB	RX	Yes	No					Y
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012	AB	RX	Yes	No					Y
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012	AB	RX	Yes	Yes					Y
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012	AB	RX	Yes	Yes					Y

International Patents for AUBAGIO

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

Country	Patent Number	Title	Estimated Expiration
Costa Rica	20120116
Morocco	33585
Australia	588629
China	104739821
Russian Federation	2012115459	ТАБЛЕТИРУЮМЫЙ ПРЕПАРАТ (4'-ТРИФТОРМЕТИЛФЕНИЛ)АМИДА (Z)-2-ЦИАНО-3-ГИДРОКСИ-БУТ-2-ЕНОЕВОЙ КИСЛОТЫ С УЛУЧШЕННОЙ УСТОЙЧИВОСТЬЮ
Japan	H05208908	CHRONIC PAIR HOST TRANSPLANTATION PIECE DISEASE REMEDY

Supplementary Protection Certificates for AUBAGIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1381356	PA2014004	Lithuania		PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356	CR 2014 00005	Denmark		PRODUCT NAME: TERIFLUNOMID, DETS STEREOISOMER OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/13/838/001-005 20130826
1381356	122014000009	Germany		PRODUCT NAME: TERIFLUNOMID, SEIN STEREOISOMER ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356	486	Finland
1381356	C300644	Netherlands		PRODUCT NAME: TERIFLUONOMIDE, ITS STEROISOMER AND PHARAMCEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356	14C0010	France		PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES.; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826

AUBAGIO (Teriflunomide): Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Executive Summary

AUBAGIO (teriflunomide) is a prescribed oral disease-modifying therapy (DMT) for relapsing forms of multiple sclerosis (RRMS). Developed by Sanofi, it has established itself as a competitive option within the MS treatment landscape. This report provides a comprehensive examination of the investment prospects, market forces, and financial trajectory for AUBAGIO, considering current market data, regulatory trends, competitor analysis, and future projections. Key insights include its market penetration, revenue streams, growth potential, and risks influencing long-term profitability.

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What Is the Current Market for AUBAGIO?

Market Overview

Parameter	Details
Therapeutic Area	Multiple Sclerosis (MS), specifically RRMS
Market Size (2022)	Estimated at $27.2 billion globally (source: GlobalData)
AUBAGIO's Market Share (2023)	Approximately 8-10% among oral MS therapies (source: IQVIA)
Pricing	Approx. $58,500 per year (U.S. list price)
Pre-approval Sales (2022)	Around $600 million globally (Sanofi Annual Report 2022)

Key Competitors

Brand Name	Market Share (2023)	Mechanism of Action	Administration	Price (approx., annual)
Tecfidera (Biogen)	25%	Dimethyl fumarate	Oral	$84,000 (U.S.)
AUBAGIO	8-10%	Selective immunomodulator, inhibits pyrimidine synthesis	Oral	$58,500 (U.S.)
Gilenya (Novartis)	20%	Sphingosine-1-phosphate receptor modulator	Oral	$89,000
Alicea (Lemtrada)	5%	Monoclonal antibody	IV	$100,000+

Note: Market share varies across geographies, with a stronger presence in Europe and expanding in emerging markets.

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What Are the Investment Drivers and Risks for AUBAGIO?

Market Dynamics Favoring Growth

• Growing MS Population: Estimated to reach 2.8 million globally by 2030, with an average annual growth rate of approximately 3% (source: MS International Federation).
• Shift Toward Oral Therapies: Oral formulations like AUBAGIO are preferred due to convenience and improved adherence.
• Regulatory Approvals: Expanded indications, including pediatric use and prevention of relapse, can open new revenue streams.
• Pricing and Reimbursement Trends: Increasing payer acceptance and tiered pricing strategies enable broader access.

Market Limitations and Risks

• Competitive Landscape: Dominated by Tecfidera and Gilenya, with existing patents and market footholds.
• Patent Expiry: Patent protection in the U.S. extends to 2027, after which generic versions could significantly impact revenue.
• Safety Profile Concerns: Known risks such as hepatotoxicity, teratogenicity, and alopecia necessitate cautious prescribing.
• Pricing Pressures: Payer pushback and biosimilar competition could erode prices.
• Regulatory Challenges: Variability in approval pathways and post-marketing surveillance costs.

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What Is the Financial Trajectory for AUBAGIO?

Historical Revenue & Growth Trends

Year	Estimated Global Revenue	% Growth (YoY)	Notable Events
2018	$420 million	-	Launch in select regions
2019	$490 million	16.7%	Expanded indications
2020	$530 million	8.2%	COVID-19 pandemic impact
2021	$570 million	7.5%	Increased market penetration
2022	$600 million	5.3%	Patent protections intact
2023	$620 million (projected)	3.3%	Rising competition

Note: Growth is expected to plateau as market matures; however, geographic expansion and indication expansion could drive upside.

Forecasted Financials (2024-2028)

Year	Estimated Revenue	CAGR	Drivers	Risks
2024	$640 million	3.2%	Continued market share, geographic expansion	Patent expiry risk
2025	$680 million	3.1%	Entry into emerging markets	Regulatory delays
2026	$720 million	3.0%	New formulations, combination therapies	Competitive patents
2027	$760 million	2.8%	Market consolidation	Biosimilar entry
2028	$790 million	2.0%	Aging MS demographic	Pricing pressures

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How Do Market Trends Impact AUBAGIO’s Investment Outlook?

Global Disease Burden and Demographic Trends

The increasing incidence of MS, especially in women aged 20-40, enhances long-term market potential. Geographic variability indicates high growth potential in emerging markets as healthcare access expands.

Policy and Reimbursement Landscape

Public and private payers are increasingly adopting value-based reimbursement. Demonstrated safety and efficacy will be critical for continued formulary inclusion.

Regulatory Environment

The FDA’s accelerated approval pathways, including Breakthrough Therapy Designation, could expedite market access for new indications. Conversely, tighter safety oversight post-approval can delay or restrict market entry.

Competitive Innovation

Emerging therapies such as oral S1P modulators (e.g., ozanimod) and biotech advances threaten to erode AUBAGIO’s market share, emphasizing the need for ongoing R&D investment and strategic patent management.

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Comparison Table: AUBAGIO vs. Key Competitors

Attribute	AUBAGIO (Teriflunomide)	Tecfidera	Gilenya	Lemtrada	Ocrevus
Mechanism	Pyrimidine synthesis inhibitor	NF-kB pathway modulator	S1P receptor modulator	Monoclonal antibody	Anti-CD20 antibody
Dosing	Once daily oral	Twice daily oral	Once daily oral	IV infusion (every 6-12 months)	IV infusion (every 6 months)
Yearly Cost	~$58,500	~$84,000	~$89,000	>$100,000	~$70,000
Market Share (2023)	8-10%	25%	20%	5%	20%

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FAQs

1. What are the growth prospects for AUBAGIO within the MS market?

The growth is primarily driven by increasing MS incidence, patient preference for oral medications, and geographic expansion, particularly in emerging markets. However, patent expiration around 2027 and competitive pressures could limit long-term growth.

2. How does patent protection influence AUBAGIO's revenue potential?

Patent protection currently extends to 2027 in the U.S., offering exclusivity. Post-expiry, generic competition can cause significant revenue declines unless the company secures new formulations or indications.

3. What are the primary risks associated with investing in AUBAGIO?

Key risks include patent expiration, market competition, safety profile concerns, regulatory delays, and pricing pressures. These factors could diminish profitability and market share.

4. How competitive is AUBAGIO compared to other MS treatments?

AUBAGIO offers an oral, once-daily regimen that is competitive regarding administration convenience. Its market share lags behind Tecfidera and Gilenya but benefits from safety profile and moderate pricing.

5. What strategies could enhance AUBAGIO's market position?

Strategies include expanding indications, entering new markets, combining therapies, optimizing pricing and reimbursement, and investing in R&D to develop next-generation formulations or delivery methods.

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Key Takeaways

• Market Position: AUBAGIO remains a relevant oral MS therapy with moderate market share, bolstered by safety and convenience profiles.
• Growth Drivers: Demographic trends, geographic expansion, and regulatory approvals are critical for future growth.
• Revenue Outlook: Expect gradual revenue increases through 2028, with potential decline post-patent expiry unless mitigated.
• Risks: Patent expiration, pricing pressures, and intense competition pose significant risk factors.
• Investment Horizon: Suitable for investors with a medium to long-term focus, considering the evolving competitive landscape and pipeline initiatives.

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References

1. GlobalData. (2022). Multiple Sclerosis Market Size & Trends.
2. IQVIA. (2023). MS Oral Therapies Market Share Report.
3. Sanofi. (2022). Annual Report.
4. MS International Federation. (2021). Global MS Epidemiology Data.
5. FDA. (2021). Regulatory Pathways for MS Therapies.

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This analysis is constructed to assist business professionals and investors in making informed decisions regarding AUBAGIO's market and financial outlook.