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-one patent family members in forty-eight 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:	81
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	15
Patent Applications:	3,475
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 Tsinghua Changgeng Hospital	Phase 2
Beijing Friendship Hospital	Phase 2
Peking University Third 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					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

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
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012

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
Austria	122033
Austria	96669
Australia	588629
Australia	6316786
Canada	1275251	MEDICAMENTS POUR COMBATTRE LE REJET DES GREFFES ET LES MALADIES AUTO-IMMUNES, NOTAMMENT LE LUPUS ERYTHEMATEUX SYSTEMIQUE (MEDICAMENTS TO COMBAT CHRONIC GRAFT-VERSUS-HOST DISEASES AND TO COMBAT AUTOIMMUNE DISEASES, IN PARTICULAR SYSTEMIC LUPUS ERYTHEMATOSUS)

Supplementary Protection Certificates for AUBAGIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C300644	Netherlands		PRODUCT NAME: TERIFLUONOMIDE, ITS STEROISOMER AND PHARAMCEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356	PA2014004	Lithuania		PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356	92366	Luxembourg		PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES
1381356	14C0010	France		PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES.; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826

Last updated: July 23, 2026

Aubagio (teriflunomide) market dynamics and financial trajectory: demand drivers, payer pressure, and exclusivity-linked risk

Aubagio (teriflunomide) is a late-cycle multiple-sclerosis (MS) brand with shrinking premium dynamics versus generics. Financial trajectory is dominated by (1) US and ex-US patent and exclusivity expiries, (2) gradual displacement by generic teriflunomide in the US and select markets, (3) payer tightening for “oral MS” categories, and (4) ongoing volume protection via safety and tolerability positioning for chronic therapy rather than high-conversion uptake.

How has Aubagio (teriflunomide) performed financially since launch?

Aubagio is a long-established oral disease-modifying therapy (DMT) for relapsing forms of multiple sclerosis. The financial trajectory since peak is characterized by typical branded oral-DMT patterning: early category growth followed by steady share erosion after generic entry, with revenue stabilizing only when lifecycle moves (switching, contract renewals, and label expansion) offset price decline.

Key business reality: the economic engine shifts from “new prescriber conversion” to “retention and access.” For an MS oral franchise, that typically means:

• formulary access depends on PBM design and prior authorization criteria,
• net price declines persist even when gross price holds,
• contract renewals determine the magnitude of displacement by generics.

When did generic teriflunomide meaningfully hit Aubagio demand in the US?

Featured snippet answer: Aubagio faces generic teriflunomide competitive pressure once FDA-approved ANDA products enter and secure formulary placement, driving lower net prices and volume share loss.

Market impact mechanics:

• Brand-to-generic switching: occurs when plans position generic as preferred with step therapy or restricted coverage for brands.
• Contract pricing: branded manufacturers respond with rebates to preserve “patient share,” but they rarely reverse the direction of net revenue decline.
• Segment effect: neurologists with entrenched patient cohorts may delay switching; new starts trend earlier to generic once coverage is stable.

What exclusivity and patent expirations shaped Aubagio’s US revenue trajectory?

Aubagio is exposed to both patent expirations and regulatory exclusivity windows (notably, US regulatory exclusivity is not the primary barrier once foundational patents expire). The practical outcome is a stepped revenue decline rather than an abrupt collapse.

Timeline logic used in oral MS brands:

• early years: core composition and dosing/regimen coverage supports brand pricing,
• middle years: life-cycle patents and formulation/method claims may delay full substitution,
• late years: once ANDA entries proliferate, branded revenue depends on contracting strategy and patient retention rather than monopoly protection.

What is the Orange Book status of Aubagio (teriflunomide) in the US?

Featured snippet answer: Aubagio’s Orange Book listings cover the approved drug product (teriflunomide tablets) and supporting patent estate for the brand, and it is typically followed by multiple generic approvals once relevant patents expire or are successfully challenged.

How Orange Book status affects business:

• Each listed patent creates a binary trigger: potential 30-month stay for ANDA Paragraph IV challenges or earlier launch if patents expire without successful challenge.
• Even after some patents expire, remaining later-listed patents can deter or delay specific ANDA launches, affecting the rate of price erosion.

What patent estate protects Aubagio formulations and methods of use?

Aubagio’s protection typically clusters around:

• composition of matter for teriflunomide,
• drug product / formulation claims for specific solid-state characteristics, manufacturing parameters, or dosage forms,
• method-of-use claims tied to dosing regimens or patient populations for relapsing MS.

Commercial relevance: method-of-use and formulation patents matter less after generic launches become entrenched, but they can still constrain certain “design-around” strategies and delay follow-on generics if the remaining patents are still being litigated or have not expired.

Which companies compete with Aubagio (teriflunomide) in relapsing MS oral therapy?

Aubagio competes in the “oral MS DMT” sleeve, facing both:

• generic teriflunomide (direct chemical equivalence competition), and
• on-patent branded competitors in oral and other administration classes, which can steal incremental starts even when generic pressure drives substitution.

Competitive dynamics that affect revenue:

• Payer tiering: oral MS plans increasingly force step therapy across branded or require preference ordering.
• Treatment tolerability profiles: dermatologic and hepatic safety monitoring affects adherence and switch patterns.
• Dosing convenience: once-daily regimens have high baseline preference, which supports category share but does not prevent net price erosion after generic entry.

How does Aubagio’s payer position compare versus other MS oral DMTs?

Featured snippet answer: Aubagio’s payer position after generic entry is defined by net price competitiveness and formulary status relative to preferred oral alternatives and generics.

Typical payer behavior in oral MS:

• preferred lists rotate between branded “value” and generic “cost” depending on PBM negotiation,
• prior authorization criteria intensify over time to restrict non-preferred use,
• patient support programs influence persistence but do not stop plan-level steering once generic tiering is locked.

What generic entry risks exist for Aubagio (teriflunomide) after patent challenges?

For late-cycle brands, the key generic risk is no longer “first generic entry.” It is:

• repeat ANDA filings that broaden the number of suppliers,
• accelerated substitution driven by PBM contract renegotiation after a sufficient supply base forms,
• portfolio displacement where generic availability triggers plan-level switching for both new starts and continuing patients.

Even when brand company remains in the market, additional generic approvals increase price competition and reduce rebating room, compressing net revenue.

What Paragraph IV ANDA challenges affected Aubagio (teriflunomide) litigation and market timing?

Featured snippet answer: Aubagio’s generic entry timing is shaped by ANDA filing and patent litigation outcomes associated with Orange Book-listed patents.

Business link to litigation:

• settlements can lock in a “launch runway” for generics and provide the brand a period to maintain formulary positioning,
• failed challenges lead to earlier launch by the first viable ANDA filer,
• the existence of multiple ANDA filers can accelerate supplier diversification, tightening pricing quickly once entry occurs.

What settlement agreements or exclusivity deals governed Aubagio’s generic launches?

For oral MS brands, settlements typically determine:

• the earliest commercial launch date for each ANDA filer,
• the scope of patents waived or still asserted,
• any “carve-outs” affecting design-around and switching.

Without a consolidated list of the specific Aubagio-related settlement documents and their effective dates, the financial effect cannot be mapped to a reliable launch-and-rebate curve.

How does Aubagio’s revenue trajectory look across geographies outside the US?

MS DMT patterns vary by:

• patent term differences and regulatory exclusivity rules,
• local generic approval timing and price regulation,
• reimbursement structures (tendering, reference pricing, negotiated caps).

General commercial effect: where generic teriflunomide is available earlier or reference-priced aggressively, revenue declines faster and net price compression is steeper. Where brand access is protected longer, revenue declines later and more gradually.

How have manufacturing supply and drug availability influenced Aubagio’s financial performance?

For branded oral therapies, supply chain stability affects net revenue through:

• fewer prescription disruptions,
• reduced substitution behavior during shortages,
• improved contract reliability with payers.

Unless there are known and documented supply disruptions for Aubagio, the typical outcome is stable supply and no major revenue shocks compared with the structural headwinds from generic competition.

Key business drivers behind Aubagio demand: adherence, monitoring costs, and switch behavior

Aubagio’s demand is anchored by the day-to-day economics of chronic therapy:

• adherence is influenced by dosing simplicity and side-effect management,
• hepatic monitoring protocols affect continuity and clinic workflow burden,
• switch patterns occur when safety monitoring or lab abnormalities prompt discontinuation or transition to another oral DMT.

These factors influence persistence, which can partially mitigate the share drop from generic and competitor penetration.

What is the financial impact of oral MS category contracting versus patient growth?

Late-cycle Aubagio performance depends on whether category growth offsets price erosion. Oral MS growth slows after:

• saturation of relapsing MS diagnosis treatment selection,
• payer restrictions that delay or cap new starts,
• switching friction to newer agents with better risk profiles or outcomes data.

Net revenue trends in this phase are typically negative even when patient numbers remain stable, because net price declines outweigh modest persistence benefits.

Aubagio vs Tecfidera, Gilenya, Ocrevus, Kesimpta: how does competitive exposure differ?

A high-level differentiation:

• Aubagio is a small-molecule oral DMT facing chemical generic competition.
• Ocrevus, Kesimpta, and similar biologics avoid direct chemical generic substitution but face payer barriers and tender competition rather than ANDA-driven price collapse.
• Tecfidera and Gilenya are also oral or injectable competitors with their own lifecycle dynamics.

Business takeaway: Aubagio’s core financial risk is direct generic substitution, while biologics face different payer mechanisms (tender and contracting), so revenue sensitivity differs even if all are exposed to cost pressure.

Aubagio lifecycle and financial trajectory summary timeline (business lens)

Period	Market structure	Revenue driver	Main downside
Brand ramp	Premium access	New starts and formulary conversion	early competitor entry
Mid-cycle	Mixed branded competition	contract renewals and persistence	pricing pressure
Late-cycle	Generic substitution	retention and rebate management	net price collapse, volume share loss
Post-entry mature stage	Multi-supplier generic	minimal incremental growth	intensified payer steering and price competition

Key Takeaways

• Aubagio’s financial trajectory is best understood as a late-cycle branded oral DMT transitioning from monopoly pricing to generic-led net price compression.
• The dominant market dynamic is generic teriflunomide substitution once FDA/Orange Book constraints no longer prevent ANDA launches and payer tiering shifts.
• Category-level payer contracting and oral MS formulary steering increasingly determine net revenue more than new patient growth.
• Litigation and Orange Book-driven generic launch timing can shift the slope of revenue decline, but once multiple generic suppliers establish, branded economics hinge on retention and contracting.

FAQs

1. How quickly do generic teriflunomide products typically reduce Aubagio market share after FDA approval?
2. Does Aubagio have materially different payer access versus other oral MS DMTs after generic entry?
3. What patient monitoring requirements most influence persistence on Aubagio versus alternative MS therapies?
4. How do PBM step-therapy programs affect continued use of Aubagio in relapsing MS?
5. What litigation outcomes would have the largest effect on future Aubagio revenue versus ongoing generic competition?

References

No sources were cited because no verifiable, detailed market or financial dataset for Aubagio’s revenue, ANDA launch timing, Orange Book patent numbers, or litigation outcomes was provided in the prompt.

DrugChatter Q&A for AUBAGIO

Aubagio patent expiration?
Aubagio loss of exclusivity date?
Aubagio loss of exclusivity?
Aubagio patent protection?
Aubagio teriflunomide availability worldwide widely available?