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 seventy-nine patent family members in forty-six countries.

The generic ingredient in AUBAGIO is teriflunomide. There are nineteen drug master file entries for this compound. Twenty-one 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:	79
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	15
Patent Applications:	2,716
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
Chinese PLA General Hospital	Phase 2
Beijing Luhe Hospital	Phase 2
Peking University First 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 and two FDA Regulatory Exclusivities.

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	6,794,410*PED				Y
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012	AB	RX	Yes	No
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012	AB	RX	Yes	Yes	9,186,346*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	5,459,163
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	5,679,709

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/002514 AUBAGIO 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/005960 Teriflunomide 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/005962 Teriflunomide 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
Russian Federation	2012115459	ТАБЛЕТИРУЮМЫЙ ПРЕПАРАТ (4'-ТРИФТОРМЕТИЛФЕНИЛ)АМИДА (Z)-2-ЦИАНО-3-ГИДРОКСИ-БУТ-2-ЕНОЕВОЙ КИСЛОТЫ С УЛУЧШЕННОЙ УСТОЙЧИВОСТЬЮ
Spain	2001996	PROCEDIMIENTO PARA PREPARAR COMPOSICIONES FARMACEUTICAS CONTRA ENFERMEDADES CRONICAS DE TRASPLANTE FRENTE A HOSPEDANTE Y CONTRA ENFERMEDADES DE AUTOINMUNIDAD. (Medicament against chronic graft-versus-host diseases, as well as against autoimmune diseases, particularly systemic lupus erythematodes.)
European Patent Office	2762135	Procédés permettant de réduire le risque d'une interaction de la rosuvastatine et du tériflunomide indésirable chez des patients atteints de sclérose en plaques (Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients)
Croatia	P20170904
Costa Rica	20170078	FORMULACIONES EN COMPROMIDO DE LA (4-TRIFLUOROMETILFENIL)AMIDA DEL ACIDO (Z)-2-CIANO-3-HIDROXIBUTIL-2-ENOICO CON ESTABILIDAD MEJORADA
Uruguay	27244	USO DEL ACIDO- (4 ́-TRIFLUORMETILFENIL) - AMIDA (Z) -2- CIANO-3- HIDROXI-BUT-2-ENOICO PARA EL TRATAMIENTO DE LA ESCLEROSIS MULTIPLE

Supplementary Protection Certificates for AUBAGIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1381356	8/2014	Austria		PRODUCT NAME: TERIFLUNOMID, SEINE STEREOISOMERE AND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/838 20130826
1381356	C 2014 006	Romania		PRODUCT NAME: TERIFLUNOMIDA, STEREOIZOMERUL SAU SI SARURILE FARMACEUTICACCEPTABILE ALEACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/838/001, EU/1/13/838/002, EU/1/13/838/003, EU/1/13/838/004, EU/1/13/838/005; DATE OF NATIONAL AUTHORISATION: 20130826; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/838/001, EU/1/13/838/002, EU/1/13/838/003, EU/1/13/838/004, EU/1/13/838/005; DATE OF FIRST AUTHORISATION IN EEA: 20130826
1381356	92366	Luxembourg		PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES
1381356	2014C/008	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
1381356	14C0010	France		PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES.; 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

AUBAGIO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aubagio

Introduction

Aubagio, developed by Sanofi, is a multiple sclerosis (MS) drug that has been a significant player in the MS treatment market since its approval in 2012. However, the drug's market dynamics and financial trajectory have undergone substantial changes, particularly with the onset of generic competition.

Market Position and Competition

Initial Market Entry

When Aubagio (teriflunomide) entered the market, it faced stiff competition from existing oral MS therapies such as Novartis' Gilenya and Biogen's Tecfidera. Despite this, Aubagio managed to carve out a niche for itself, particularly due to its unique clinical profile, including the absence of associated reports of progressive multifocal leukoencephalopathy (PML), a rare brain infection linked to other MS drugs[3][4].

Growth and Market Share

In its early years, Aubagio saw significant growth, with sales increasing by 21% in 2017 compared to the previous year, reaching $1.2 billion. This growth was attributed to its real-world profile and data showing significant impacts on disability progression in MS patients[4].

Impact of Generic Competition

Loss of Patent Exclusivity

A critical turning point for Aubagio was the loss of its patent exclusivity in the US in March 2023. This event allowed generic versions of the drug to enter the market, significantly increasing competition. Companies such as Teva, Sandoz, Mylan, Zydus, and Accord Healthcare have received approvals for generic versions of Aubagio, leading to a steep decline in Sanofi's revenue from the drug[1][2].

Revenue Decline

The financial impact of generic competition has been profound. In Q2 2024, Aubagio sales dropped by 49.5% to €107 million, reflecting the loss of exclusivity in both the US and Europe. This decline is part of a broader trend, with Q1 2023 revenues already down 14.6% year-over-year from €491 million to €419 million[1][2].

Global Market Impact

US Market

In the US, the approval of generic versions has led to a rapid decline in Aubagio's sales. Accord Healthcare, for example, announced it was ready to ship its generic version in March 2023, further intensifying the competition[1].

European Market

The loss of exclusivity in Europe, expected in Q4 2023, is anticipated to accelerate the decline in global Aubagio revenue. This dual impact from both US and European markets is expected to continue over the short-to-medium term[1].

Sanofi's Strategic Response

Focus on Dupixent

To offset the revenue losses from Aubagio, Sanofi is increasingly focusing on its blockbuster drug Dupixent (dupilumab). Dupixent has been a strong performer, with global sales of €8.3 billion in 2022 and a 43.8% year-over-year increase. The drug's approvals in new indications, such as chronic obstructive pulmonary disease (COPD), are expected to further boost its sales[1][2].

Diversification of Portfolio

Sanofi is also diversifying its portfolio by advancing other drugs through the pipeline. This includes regulatory submissions for drugs like tolebrutinib in MS, fitusiran in hemophilia, and rilzabrutinib in immune thrombocytopenia. These efforts aim to mitigate the impact of generic competition on Aubagio and ensure sustained revenue growth[5].

Financial Performance

Quarterly and Annual Sales

The financial performance of Aubagio has been significantly impacted by generic competition. In Q4 2023, Aubagio sales dropped by 74% to just over $130 million, contributing to Sanofi's net income loss of approximately $600 million. Despite this, Sanofi's overall net sales in Q4 2023 grew by 9.3% at constant exchange rates, driven largely by the success of Dupixent and other products[5].

Business Operating Income

Sanofi's business operating income (BOI) has also been affected, with a 5.2% drop in the fourth quarter of 2023 compared to the same period the previous year. However, the company's overall BOI increased by 8.3% at constant exchange rates in Q2 2024, reflecting the resilience of its diversified portfolio[2].

Future Outlook

Continued Generic Competition

The decline in Aubagio revenue is expected to continue as more generic versions enter the market. This trend will likely dominate the MS drug market until a new drug with significant benefits is developed[1].

Sanofi's Pipeline and Diversification

Sanofi's focus on growing sales for Dupixent and advancing its pipeline of new medicines will be crucial in offsetting the losses from Aubagio. The company's strong performance in other areas, such as vaccines and new drug approvals, will help maintain its financial stability and growth trajectory[2][5].

Key Takeaways

• Generic Competition: The loss of patent exclusivity has led to a significant decline in Aubagio's revenue due to generic competition.
• Revenue Decline: Aubagio sales have dropped substantially, with a 49.5% decline in Q2 2024.
• Sanofi's Response: The company is focusing on growing sales for Dupixent and diversifying its portfolio to offset losses.
• Financial Impact: Despite the decline in Aubagio sales, Sanofi's overall net sales and business operating income remain strong due to other successful products.
• Future Outlook: The decline in Aubagio revenue is expected to continue, but Sanofi's pipeline and diversification efforts will help maintain its financial stability.

FAQs

What is the primary reason for the decline in Aubagio's revenue?

The primary reason for the decline in Aubagio's revenue is the loss of patent exclusivity, allowing generic versions of the drug to enter the market.

How has Sanofi responded to the decline in Aubagio sales?

Sanofi has responded by focusing on growing sales for its blockbuster drug Dupixent and diversifying its portfolio with new drug approvals and pipeline advancements.

What are the new indications for Dupixent that could boost its sales?

Dupixent has received approvals in new indications, including chronic obstructive pulmonary disease (COPD), and is in Phase III studies for several other conditions such as bullous pemphigoid and chronic spontaneous urticaria.

How has the loss of exclusivity in Europe affected Aubagio's sales?

The loss of exclusivity in Europe, expected in Q4 2023, is anticipated to further accelerate the decline in global Aubagio revenue.

What is Sanofi's overall financial performance despite the decline in Aubagio sales?

Despite the decline in Aubagio sales, Sanofi's overall net sales and business operating income remain strong, driven by the success of other products like Dupixent and its diversified portfolio.

Sources

1. Fitch Solutions: "Sanofi's Aubagio Revenues Will Continue To Decline Amid Rising Generic Competition" - July 14, 2023
2. Sanofi: "Q2: strong performance with 10% sales growth; 2024" - July 25, 2024
3. FiercePharma: "Buoyed by rising tide of Aubagio scripts, Sanofi aims for €2B in MS sales" - November 9, 2015
4. MM+M: "How Aubagio became the most switched-to oral MS drug" - November 1, 2017
5. BioSpace: "Sanofi Hit with $600M Net Loss in Q4 Amid Generic Competition" - February 1, 2024