Glecaprevir; pibrentasvir - Generic Drug Details

What are the generic sources for glecaprevir; pibrentasvir and what is the scope of patent protection?

Glecaprevir; pibrentasvir is the generic ingredient in one branded drug marketed by Abbvie and is included in two NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Glecaprevir; pibrentasvir has five hundred and thirty-four patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for glecaprevir; pibrentasvir

International Patents:	534
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	31
DailyMed Link:	glecaprevir; pibrentasvir at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for glecaprevir; pibrentasvir

Dosage:

TABLET;ORAL

Dosage:

PELLETS;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 glecaprevir; pibrentasvir

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

Sponsor	Phase
White River Junction Veterans Affairs Medical Center	Phase 2
Peking University People's Hospital	Phase 4
White River Junction Veterans Affairs Medical Center	Phase 2/Phase 3

See all glecaprevir; pibrentasvir clinical trials

Pharmacology for glecaprevir; pibrentasvir

Drug Class	Hepatitis C Virus NS3/4A Protease Inhibitor Hepatitis C Virus NS5A Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 1A2 Inhibitors Cytochrome P450 3A Inhibitors HCV NS3/4A Protease Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors UGT1A1 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for glecaprevir; pibrentasvir

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for glecaprevir; pibrentasvir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes					Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes					Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes					Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes

EU/EMA Drug Approvals for glecaprevir; pibrentasvir

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH Co. KG	Maviret	glecaprevir, pibrentasvir	EMEA/H/C/004430 Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and children aged 3 years and older.Maviret coated granules is indicated for the treatment of chronic hepatitis C virus (HCV) infection in children 3 years and older.	Authorised	no	no	no	2017-07-26

International Patents for glecaprevir; pibrentasvir

Country	Patent Number	Title	Estimated Expiration
Mexico	2020001422	METODOS PARA EL TRATAMIENTO DE HCV. (METHODS FOR TREATING HCV.)
Brazil	112016022976	métodos para o tratamento de hcv
European Patent Office	2618831	INHIBITEURS MACROCCLIQUES DE LA SÉRINE PROTÉASE DU VHC DÉRIVÉS DE LA PROLINE (MACROCYCLIC PROLINE DERIVED HCV SERINE PROTEASE INHIBITORS)
South Korea	20180026775	항바이러스 화합물 (ANTI-VIRAL COMPOUNDS)

Supplementary Protection Certificates for glecaprevir; pibrentasvir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2618831	PA2017034	Lithuania		PRODUCT NAME: GLEKAPREVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA ESTERIS; REGISTRATION NO/DATE: EU/1/17/1213 20170726
2618831	CR 2017 00048	Denmark		PRODUCT NAME: GLECAPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REG. NO/DATE: EU/1/17/1213 20170728
2368890	15C0016	France		PRODUCT NAME: OMBITASVIR DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/14/982 20150119
2368890	2015012	Norway		PRODUCT NAME: OMBITASVIR, ELLER ET; REG. NO/DATE: EU/1/14/982 20150120

Glecaprevir; pibrentasvir Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Glecaprevir/Pibrentasvir

Introduction

Glecaprevir/pibrentasvir, a pan-genotypic direct-acting antiviral (DAA) combination, has revolutionized the treatment of chronic hepatitis C virus (HCV) infection. This article delves into the market dynamics and financial trajectory of this drug, highlighting its efficacy, cost-effectiveness, and global market impact.

Efficacy and Clinical Outcomes

Glecaprevir/pibrentasvir, marketed as Mavyret, has demonstrated exceptional clinical efficacy across all six major HCV genotypes. Clinical trials have shown that this regimen achieves high sustained virologic response (SVR) rates, ranging from 93% to 100%, regardless of the patient's HCV genotype or previous treatment history[4][5].

Cost-Effectiveness Analysis

Studies in various regions, including Japan and China, have consistently shown that glecaprevir/pibrentasvir is a cost-effective treatment option. In Japan, it was found to be dominant over other DAAs, generating higher quality-adjusted life years (QALYs) and lower lifetime costs[1].

In China, the cost-effectiveness analysis indicated that the GLE/PIB regimen could save significant costs while achieving high SVR rates. For HCV genotype 1 infection, the regimen was estimated to save $1,656 compared to other treatments[2].

Pricing and Market Competitiveness

The pricing of glecaprevir/pibrentasvir is a critical factor in its market success. The treatment costs between $26,000 to $54,000 for an 8 to 16-week course, which is substantially lower than other DAA regimens like sofosbuvir/velpatasvir and sofosbuvir/ledipasvir[4].

Global Market Impact

Approval and Availability

Glecaprevir/pibrentasvir has been approved in several countries, including the United States, Japan, and China. Its approval has expanded treatment options for HCV patients worldwide, particularly in regions where access to newer DAAs was previously limited[2][4].

Market Penetration

The drug's pan-genotypic efficacy and shorter treatment duration have contributed to its rapid market penetration. In regions like Europe, the removal of reimbursement restrictions and financial competition among pharmaceutical companies have further facilitated its adoption[3].

Financial Trajectory

Revenue Growth

The financial performance of glecaprevir/pibrentasvir has been robust since its launch. As one of the key products of AbbVie, it has contributed significantly to the company's revenue. The drug's competitive pricing and high efficacy have driven its sales, making it a major player in the HCV treatment market.

Cost Savings for Healthcare Systems

The cost-effectiveness of glecaprevir/pibrentasvir translates into significant savings for healthcare systems. By reducing the lifetime costs associated with HCV treatment, this regimen helps in managing healthcare budgets more efficiently. For instance, in Japan, the study indicated that the GLE/PIB portfolio was cost-effective in 100% of simulations up to a certain willingness-to-pay threshold[1].

Patient Access and Affordability

Access Programs

AbbVie and other stakeholders have implemented various access programs to make glecaprevir/pibrentasvir more affordable for patients. These programs include discounts, patient assistance plans, and partnerships with healthcare providers to reduce the financial burden on patients.

Impact on Public Health

The affordability and accessibility of glecaprevir/pibrentasvir have significant public health implications. By making effective HCV treatment more accessible, it helps in reducing the prevalence of HCV and associated complications like hepatocellular carcinoma.

Regulatory and Policy Environment

Regulatory Approvals

The regulatory environment has been favorable for glecaprevir/pibrentasvir, with approvals from major regulatory bodies such as the FDA and EMA. These approvals have been based on robust clinical data demonstrating the drug's safety and efficacy.

Policy Support

Government policies and reimbursement strategies have also supported the adoption of glecaprevir/pibrentasvir. For example, the removal of reimbursement restrictions in Europe has facilitated wider access to this treatment[3].

Future Outlook

Ongoing Research and Development

AbbVie continues to invest in research and development to further enhance the treatment outcomes of glecaprevir/pibrentasvir. Studies are ongoing to evaluate its efficacy in patients with specific treatment challenges, such as those with chronic kidney disease or previous treatment failures[5].

Market Expansion

The drug is expected to continue its market expansion as more countries approve it and as access programs are extended. The growing awareness of HCV treatment options and the increasing demand for effective and affordable therapies will likely drive the sales of glecaprevir/pibrentasvir.

Key Takeaways

• High Efficacy: Glecaprevir/pibrentasvir achieves high SVR rates across all six HCV genotypes.
• Cost-Effectiveness: It is a cost-effective treatment option compared to other DAAs.
• Competitive Pricing: The drug is priced lower than many other DAA regimens.
• Global Approval: Approved in several countries, including the US, Japan, and China.
• Financial Impact: Contributes significantly to AbbVie's revenue and helps in cost savings for healthcare systems.
• Patient Access: Various access programs make it more affordable for patients.

FAQs

1. What is the efficacy of glecaprevir/pibrentasvir in treating HCV?

   • Glecaprevir/pibrentasvir achieves high SVR rates, ranging from 93% to 100%, across all six HCV genotypes[4][5].

2. How does the cost of glecaprevir/pibrentasvir compare to other DAA regimens?

   • The treatment costs between $26,000 to $54,000, which is substantially lower than other DAA regimens like sofosbuvir/velpatasvir and sofosbuvir/ledipasvir[4].

3. Is glecaprevir/pibrentasvir available globally?

   • It has been approved in several countries, including the US, Japan, and China, but availability may vary by region[2][4].

4. What are the key factors contributing to the cost-effectiveness of glecaprevir/pibrentasvir?

   • High SVR rates, shorter treatment duration, and lower lifetime costs compared to other DAAs contribute to its cost-effectiveness[1][2].

5. Are there any ongoing research and development efforts for glecaprevir/pibrentasvir?

   • Yes, AbbVie continues to invest in research to evaluate its efficacy in patients with specific treatment challenges and to further enhance treatment outcomes[5].

Sources

1. A Cost-Effectiveness Analysis of Glecaprevir/Pibrentasvir Versus ... - PubMed
2. Cost-effectiveness analysis of glecaprevir/pibrentasvir regimen for ... - AME Publishing
3. Directly observed therapy for HCV with glecaprevir/pibrentasvir ... - PLOS ONE
4. Glecaprevir/Pibrentasvir (Mavyret) for the Treatment of Chronic ... - American Academy of Family Physicians
5. Eight Weeks of Treatment with AbbVie's Investigational, Pan ... - AbbVie News