AVACOPAN - Generic Drug Details

What are the generic drug sources for avacopan and what is the scope of freedom to operate?

Avacopan is the generic ingredient in one branded drug marketed by Chemocentryx and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for AVACOPAN

International Patents:	108
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	4
Patent Applications:	150
What excipients (inactive ingredients) are in AVACOPAN?	AVACOPAN excipients list
DailyMed Link:	AVACOPAN at DailyMed

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

Constraining patent/regulatory exclusivity:

8,445,515

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.

Recent Clinical Trials for AVACOPAN

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

Sponsor	Phase
Amgen	Phase 4
Medpace, Inc.	Phase 2
ChemoCentryx	Phase 2

See all AVACOPAN clinical trials

Pharmacology for AVACOPAN

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

Anatomical Therapeutic Chemical (ATC) Classes for AVACOPAN

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

L04AJ	Complement inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for AVACOPAN

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	8,445,515		Y	Y
Chemocentryx	TAVNEOS	avacopan	CAPSULE;ORAL	214487-001	Oct 7, 2021		RX	Yes	Yes
Chemocentryx	TAVNEOS	avacopan	CAPSULE;ORAL	214487-001	Oct 7, 2021		RX	Yes	Yes	11,603,356		Y	Y

EU/EMA Drug Approvals for AVACOPAN

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 AVACOPAN

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)

Supplementary Protection Certificates for AVACOPAN

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

AVACOPAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Avacopan

Introduction

Avacopan, a first-in-class, orally administered selective inhibitor of the complement C5a receptor, has been at the forefront of treating severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis) and other inflammatory diseases. Here, we delve into the market dynamics and financial trajectory of this drug.

Regulatory Approval and Clinical Trials

FDA Approval and Concerns

Avacopan, marketed as TAVNEOS, received approval from the FDA for the treatment of ANCA-associated vasculitis. However, the FDA's briefing document highlighted several concerns regarding the clinical data from the Phase III trial, particularly the subgroup analysis suggesting that avacopan's efficacy might be limited to patients not receiving standard-of-care maintenance immunosuppression therapy[1].

International Approvals

Despite the FDA's concerns, TAVNEOS has gained approvals in other regions, including the European Union and Canada, expanding its market reach[3].

Market Performance

Commercial Success

In the first quarter of 2022, TAVNEOS generated significant commercial traction, with a five-fold increase in net sales compared to the fourth quarter of 2021, reaching $5.4 million. The number of new patient start forms, unique prescribers, and patients on the drug also saw substantial increases[3].

Key Performance Indicators

• New Patient Start Forms: 248 forms received in Q1 2022.
• Unique Prescribers: 281 prescribers to date.
• Patients on Drug: 277 patients as of March 31, 2022[3].

Financial Highlights

Revenue Growth

The strong commercial execution of TAVNEOS led to a marked growth in revenue. The company's cash position remained robust, with approximately $371.8 million in cash, cash equivalents, and investments as of March 31, 2022, including a $45 million milestone payment from Vifor Pharma following EU approval[3].

Collaboration and License Revenue

While the collaboration and license revenue decreased in Q1 2022 compared to the previous year due to the absence of a significant milestone payment, the overall financial health of the company remained stable[3].

Cost-Utility Analysis

Economic Viability

A cost-utility analysis conducted in Spain indicated that avacopan is a cost-effective option for treating severe, active ANCA-associated vasculitis. The study showed that avacopan yielded an increase in quality-adjusted life years (QALYs) and was associated with lower incidence of end-stage renal disease, relapse, and hospitalization-related adverse events[2].

Expansion into Other Indications

Hidradenitis Suppurativa (HS)

Avacopan has shown promising results in the treatment of hidradenitis suppurativa, a chronic disabling skin disease. The Phase II AURORA trial demonstrated a statistically significant higher response rate in patients with Hurley Stage III (severe) HS, indicating a potential new therapeutic avenue[5].

Other Inflammatory Diseases

Avacopan is also being studied for its efficacy in other inflammatory diseases, including hidradenitis suppurativa, complement 3 glomerulopathy (C3G), and potentially lupus nephritis, further expanding its market potential[4][5].

Acquisition by Amgen

Strategic Acquisition

In October 2022, Amgen successfully completed the acquisition of ChemoCentryx, adding TAVNEOS to its inflammation portfolio. This acquisition is expected to enhance the global reach and marketing capabilities of avacopan, potentially boosting its financial trajectory[4].

Challenges and Risks

Regulatory and Clinical Concerns

Despite the positive market performance, the FDA's concerns over the clinical data and the need for further discussions on the benefit-risk assessment pose regulatory risks. Additionally, the competitive landscape, pricing pressure, and reimbursement policies can impact the drug's long-term financial success[1][4].

Key Takeaways

• Regulatory Approvals: TAVNEOS has received FDA approval and international approvals despite initial concerns.
• Commercial Success: Significant growth in net sales, prescribers, and patients on the drug.
• Financial Health: Robust cash position and revenue growth.
• Cost-Utility: Avacopan is cost-effective in treating ANCA-associated vasculitis.
• Expansion: Promising results in other indications like hidradenitis suppurativa.
• Acquisition: Amgen's acquisition expected to enhance global reach and marketing.

FAQs

What is avacopan used for?

Avacopan, marketed as TAVNEOS, is used for the treatment of severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis).

What were the FDA's concerns regarding avacopan?

The FDA raised concerns about the subgroup analysis suggesting that avacopan's efficacy might be limited to patients not receiving standard-of-care maintenance immunosuppression therapy[1].

How has TAVNEOS performed commercially?

TAVNEOS saw a five-fold increase in net sales in Q1 2022 compared to Q4 2021, with significant growth in new patient start forms, unique prescribers, and patients on the drug[3].

Is avacopan cost-effective?

Yes, a cost-utility analysis indicated that avacopan is a cost-effective option for treating severe, active ANCA-associated vasculitis in Spain[2].

What other diseases is avacopan being studied for?

Avacopan is being studied for its efficacy in hidradenitis suppurativa, complement 3 glomerulopathy (C3G), and potentially lupus nephritis[4][5].

Who acquired ChemoCentryx?

Amgen acquired ChemoCentryx in October 2022, adding TAVNEOS to its inflammation portfolio[4].

Sources

1. Biospace: FDA Cites Concerns Over ChemoCentryx's Avacopan Trial Data
2. PubMed: A projected cost-utility analysis of avacopan for the treatment of ANCA-associated vasculitis
3. Biospace: ChemoCentryx Reports First Quarter 2022 Financial Results and Recent Highlights
4. Amgen: AMGEN SUCCESSFULLY COMPLETES ACQUISITION OF CHEMOCENTRYX
5. Biospace: ChemoCentryx Announces Positive Topline Results of Phase II AURORA Clinical Trial of Avacopan in the Treatment of Hidradenitis Suppurativa (HS)