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TAVNEOS Drug Patent Profile

Which patents cover Tavneos, and when can generic versions of Tavneos launch?

Tavneos is a drug marketed by Chemocentryx and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and eight patent family members in thirty-seven countries.

The generic ingredient in TAVNEOS is avacopan. One supplier is listed for this compound. Additional details are available on the avacopan profile page.

DrugPatentWatch^® Generic Entry Outlook for Tavneos

Tavneos will be eligible for patent challenges on October 7, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 3, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TAVNEOS

International Patents:	108
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Patent Applications:	90
Drug Prices:	Drug price information for TAVNEOS
What excipients (inactive ingredients) are in TAVNEOS?	TAVNEOS excipients list
DailyMed Link:	TAVNEOS at DailyMed

See drug prices for TAVNEOS

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TAVNEOS

NDA:

214487

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for TAVNEOS

Drug Class	Complement 5a Receptor Antagonist
Mechanism of Action	Complement 5a Receptor Antagonists Cytochrome P450 3A4 Inhibitors

US Patents and Regulatory Information for TAVNEOS

TAVNEOS is protected by four US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chemocentryx	TAVNEOS	avacopan	CAPSULE;ORAL	214487-001	Oct 7, 2021		RX	Yes	Yes			Y	Y
Chemocentryx	TAVNEOS	avacopan	CAPSULE;ORAL	214487-001	Oct 7, 2021		RX	Yes	Yes			Y	Y
Chemocentryx	TAVNEOS	avacopan	CAPSULE;ORAL	214487-001	Oct 7, 2021		RX	Yes	Yes			Y
Chemocentryx	TAVNEOS	avacopan	CAPSULE;ORAL	214487-001	Oct 7, 2021		RX	Yes	Yes			Y	Y

EU/EMA Drug Approvals for TAVNEOS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Vifor Fresenius Medical Care Renal Pharma France	Tavneos	avacopan	EMEA/H/C/005523 Tavneos, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).	Authorised	no	no	yes	2022-01-11

International Patents for TAVNEOS

When does loss-of-exclusivity occur for TAVNEOS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Colombia

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

France

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Mexico

Morocco

Netherlands

New Zealand

Norway

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TAVNEOS around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	201028380	C5aR antagonists
Argentina	117219	FORMULACIONES EN CÁPSULAS, MÉTODO DE PREPARACIÓN
Japan	2017193586	Ｃ５ａＲアンタゴニスト (C5AR ANTAGONISTS)
Hong Kong	1164639	拮抗劑 (C5AR ANTAGONISTS C5AR)

Supplementary Protection Certificates for TAVNEOS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2381778	LUC00258	Luxembourg		PRODUCT NAME: AVACOPAN ET LES SELS PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT; AUTHORISATION NUMBER AND DATE: EU/1/21/1605 20220119
2381778	CA 2022 00022	Denmark		PRODUCT NAME: AVACOPAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/21/1605 20220119
2381778	301166	Netherlands		PRODUCT NAME: AVACOPAN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1605 20220119
2381778	17/2022	Austria		PRODUCT NAME: AVACOPAN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/21/1605 (MITTEILUNG) 20220119

TAVNEOS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TAVNEOS

Introduction to TAVNEOS

TAVNEOS, developed by ChemoCentryx, is a groundbreaking drug approved by the FDA for the treatment of anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis), specifically for granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)[1][3][4].

FDA Approval and Regulatory Milestones

The FDA approved TAVNEOS (avacopan) in October 2021 as an adjunctive treatment for adults with severe active ANCA-associated vasculitis. This approval marked a significant milestone, as TAVNEOS is the first FDA-approved orally administered inhibitor of the complement C5a receptor[1][3].

Global Approvals

In addition to the FDA approval, TAVNEOS has been approved in other regions. It was approved in Japan in September 2021 and later in the European Union in January 2022, followed by approval in Canada in April 2022. These approvals have expanded the drug's reach and potential market[1][2][4].

Market Need and Impact

ANCA-associated vasculitis is a systemic autoimmune disease with significant unmet medical needs. Current therapies often lead to serious side effects and a diminished quality of life. The approval of TAVNEOS brings a much-needed new treatment option, offering a brighter future for patients. The vasculitis community has welcomed this drug as it addresses the limitations of existing treatments[1][3].

Clinical Trial Success

The approval of TAVNEOS was supported by the results of the pivotal Phase III ADVOCATE trial, which demonstrated the drug's efficacy in achieving disease remission at 26 weeks and sustained remission at 52 weeks. The trial showed superiority over a prednisone-based standard of care in terms of sustained remission[3].

Commercial Performance

Since its approval, TAVNEOS has shown promising commercial performance. In the first quarter of 2022, the drug generated $5.4 million in US net product sales, representing a five-fold increase from the previous quarter. Key performance indicators such as new patient start forms, unique prescribers, and patients on the drug have also seen significant growth[2].

Financial Highlights

• Revenue Growth: TAVNEOS US net product sales were $5.4 million for the first quarter of 2022, with a notable increase in key performance indicators such as new patient start forms (195% increase), unique prescribers (275% increase), and patients on the drug (308% increase)[2].
• Milestone Payments: The EU approval of TAVNEOS triggered a non-refundable $45 million milestone payment from Vifor Pharma, which was received in full and included in ChemoCentryx's reported cash balance[2].
• Royalties: Vifor Pharma, ChemoCentryx's partner, will pay royalties in the teens to the mid-20s percent on aggregate net sales from territories outside the US[2].

Expanding Market Presence

ChemoCentryx’s partner, Vifor Pharma, has initiated marketing activities for TAVNEOS in several European markets, including Germany and Austria, with plans to launch in other markets in 2022. This strategic partnership has helped in expanding the drug's market presence beyond the US[2].

Cash Position and Financial Stability

As of March 31, 2022, ChemoCentryx maintained a strong balance sheet with cash, cash equivalents, and investments totaling approximately $371.8 million. This financial stability is crucial for the continued development and commercialization of TAVNEOS[2].

Research and Development Expenses

Research and development expenses for the first quarter of 2022 were $17.5 million, lower than the same period in 2021 due to the completion of the TAVNEOS AURORA Phase IIb clinical trial and reduced manufacturing costs. However, there was an increase in research and drug discovery expenses for other projects[2].

Selling, General, and Administrative Expenses

Selling, general, and administrative expenses increased to $26.0 million in the first quarter of 2022, primarily due to higher employee-related expenses and professional fees associated with the launch and commercialization of TAVNEOS[2].

Net Loss and Share Performance

Despite the growth in sales, ChemoCentryx reported a net loss of $38.6 million for the first quarter of 2022, compared to a net loss of $29.7 million for the same period in 2021. The total shares outstanding as of March 31, 2022, were approximately 71.1 million shares[2].

Recent Financial Performance

In more recent financial reports, TAVNEOS continues to show strong growth. For example, in the first quarter of 2024, TAVNEOS generated $51 million in sales, a 122% year-over-year increase driven by volume growth[5].

Key Takeaways

• Regulatory Success: TAVNEOS has received approvals in multiple regions, including the US, EU, Japan, and Canada.
• Clinical Efficacy: The drug has demonstrated superiority over traditional treatments in clinical trials.
• Commercial Growth: Significant increases in sales, new patient start forms, unique prescribers, and patients on the drug.
• Financial Stability: Strong cash position and milestone payments supporting continued development and commercialization.
• Expanding Market: Strategic partnerships with Vifor Pharma have expanded the drug's market presence globally.

FAQs

Q: What is TAVNEOS used for?

TAVNEOS (avacopan) is used as an adjunctive treatment for adults with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis), specifically for granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)[1].

Q: How was TAVNEOS approved?

TAVNEOS was approved by the FDA in October 2021 based on the results of the pivotal Phase III ADVOCATE trial, which demonstrated the drug's efficacy in achieving disease remission and sustained remission[3].

Q: What are the common side effects of TAVNEOS?

Common side effects include nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increase, and paresthesia (burning or prickling sensation)[1].

Q: Who are the key partners for TAVNEOS outside the US?

ChemoCentryx has a partnership with Vifor Pharma, which holds exclusive rights to commercialize TAVNEOS in markets outside the US[2].

Q: How has TAVNEOS performed financially since its approval?

TAVNEOS has shown significant financial growth, with a five-fold increase in US net product sales in the first quarter of 2022 compared to the previous quarter, and continued growth in subsequent quarters[2][5].

Cited Sources

1. FDA Finally Approves ChemoCentryx's Tavneos for ANCA Vasculitis - BioSpace
2. ChemoCentryx Reports First Quarter 2022 Financial Results and Recent Highlights - BioSpace
3. ChemoCentryx Announces FDA Approval of TAVNEOS (avacopan) in ANCA-Associated Vasculitis - BioSpace
4. Tavneos, INN-avacopan - European Medicines Agency
5. AMGEN REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS - PR Newswire