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MAVYRET Drug Patent Profile

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

Mavyret is a drug marketed by Abbvie and is included in two NDAs. There are ten patents protecting this drug.

This drug has five hundred and thirty-four patent family members in forty-six countries.

The generic ingredient in MAVYRET is glecaprevir; pibrentasvir. One supplier is listed for this compound. Additional details are available on the glecaprevir; pibrentasvir profile page.

DrugPatentWatch^® Generic Entry Outlook for Mavyret

Mavyret was eligible for patent challenges on August 3, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 5, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for MAVYRET

International Patents:	534
US Patents:	10
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	29
Drug Prices:	Drug price information for MAVYRET
What excipients (inactive ingredients) are in MAVYRET?	MAVYRET excipients list
DailyMed Link:	MAVYRET at DailyMed

See drug prices for MAVYRET

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

Constraining patent/regulatory exclusivity:

11,246,866*PED

NDA:

209394

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

9,321,807*PED

NDA:

215110

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 MAVYRET

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

Sponsor	Phase
White River Junction Veterans Affairs Medical Center	Phase 2
White River Junction Veterans Affairs Medical Center	Phase 2/Phase 3
Duke University	Phase 4

See all MAVYRET clinical trials

Pharmacology for MAVYRET

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

US Patents and Regulatory Information for MAVYRET

MAVYRET is protected by ten US patents and five FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,321,807.

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
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	RE48923*PED				Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes	10,286,029*PED				Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	8,937,150*PED				Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	9,586,978*PED				Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes	8,648,037*PED				Y
Abbvie	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes	RE48923*PED				Y

EU/EMA Drug Approvals for MAVYRET

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 MAVYRET

When does loss-of-exclusivity occur for MAVYRET?

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

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

Peru

Philippines

Russian Federation

Singapore

South Africa

South Korea

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 MAVYRET around the world.

Country	Patent Number	Title	Estimated Expiration
Costa Rica	20130135	INHIBIDORES DE LAS PROTEASAS DE SERINA DEL VHC DERIVADOS DE PROLINAS MACROCÌCLICAS
Dominican Republic	P2013000078	COMPUESTO DERIVADO DE HETEROCICLOS NITROGENADOS SUSTITUIDOS, EFICAZ COMO INHIBIDOR DE LA REPLICACIÓN DEL VIRUS DE LA HEPATITIS C, COMPOSICIÓN QUE LO COMPRENDE Y SU USO
Lithuania	C2692346
Hong Kong	1170739	作為丙型肝炎病毒 抑制劑的雜環化合物 (HETEROCYCLIC COMPOUNDS AS INHIBITORS OF HEPATITIS C VIRUS (HCV) (HCV))
Taiwan	201347759	Anti-viral compounds
European Patent Office	2678334	COMPOSÉS ANTIVIRAUX (ANTI-VIRAL COMPOUNDS)
Malaysia	164754	MACROCYCLIC PROLINE DERIVED HCV SERINE PROTEASE INHIBITORS

Supplementary Protection Certificates for MAVYRET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2368890	2015/010	Ireland		PRODUCT NAME: OMBITASVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/982 20150115
2618831	1791051-4/1790051-5	Sweden		PRODUCT NAME: GLECAPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF
2692346	51/2017	Austria		PRODUCT NAME: PIBRENTASVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1213 (MITTEILUNG) 20170728
2368890	2015012	Norway		PRODUCT NAME: OMBITASVIR, ELLER ET; REG. NO/DATE: EU/1/14/982 20150120
2692346	SPC/GB17/056	United Kingdom		PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/17/1213 (NI) 20170728; UK PLGB 41042/0030 20170728; UK PLGB 41042/0043 20170728
2692346	CR 2017 00049	Denmark		PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT 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

MAVYRET Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Mavyret

Introduction to Mavyret

Mavyret, a fixed-dose combination of glecaprevir and pibrentasvir, was approved by the FDA in August 2017 for the treatment of all six genotypes of hepatitis C. Developed by AbbVie, Mavyret has significantly impacted the hepatitis C market, challenging the dominance of Gilead Sciences.

Market Entry and Initial Success

Upon its launch, Mavyret surprised investors with its rapid uptake and strong sales performance. In the first six months of 2018, Mavyret generated over $1.8 billion in sales, far exceeding initial predictions[1][3].

Competitive Pricing

A key factor in Mavyret's success was its competitive pricing strategy. AbbVie introduced Mavyret at a significantly lower price point than Gilead's Sovaldi and Harvoni, with a treatment course costing $26,400, compared to $28,000 and $31,500 for Sovaldi and Harvoni, respectively. This pricing, combined with a shorter 8-week treatment duration, made Mavyret an attractive option for patients and payers[3].

Market Share

Mavyret quickly gained a substantial share of the hepatitis C market. By the end of 2018, it had secured about 50% of new prescriptions, outpacing Gilead's Harvoni and Epclusa. This aggressive market entry strategy allowed AbbVie to capture a significant portion of the market, particularly in the U.S., where Mavyret secured access to more than three-quarters of covered lives[1][3].

Financial Performance

Initial Revenue Growth

In its first year, Mavyret contributed nearly $500 million to AbbVie's total hepatitis C sales of $1.3 billion. By 2018, AbbVie raised its guidance for hepatitis C sales to above $3.5 billion, largely driven by Mavyret's success[1][3].

Long-Term Projections

Evaluate analysts predicted that Mavyret could achieve annual sales of $1.25 billion by 2022. However, Leerink analysts later adjusted their revenue forecasts downward by 9% to 16% through 2022, citing the expected decline in the number of patients treated due to the high cure rate of current therapies[1][3].

Impact on the Hepatitis C Market

Market Dynamics

The hepatitis C market has been undergoing significant changes. The high cure rates of current treatments, including Mavyret and Gilead's drugs, have led to a shrinking patient pool. The number of patients beginning treatment has steadily declined since 2015, and this trend is expected to continue[1][5].

Competition and Market Share

Mavyret's entry disrupted Gilead's dominance in the hepatitis C market. Gilead's guidance for 2018 hepatitis C sales was significantly lower than analyst expectations, reflecting the impact of Mavyret's competitive pricing and broader indication covering all six genotypes of hepatitis C[3].

Sustainability of Growth

Patient Pool and Treatment Dynamics

The initial surge in Mavyret sales was partly due to patients who had failed other treatments or were waiting for a new option. However, as these patients have been treated, the growth rate is expected to slow down. Analysts predict a decline in Mavyret sales in the third and fourth quarters due to this factor[1].

AbbVie's Diversification Strategy

Despite the expected slowdown, AbbVie remains confident in Mavyret's long-term potential. The drug is seen as a cornerstone in AbbVie's diversification plans beyond its top-selling drug Humira. Other growth drivers for AbbVie include Imbruvica, Venclexta, and Orilissa, as well as experimental drugs like upadacitinib and risankizumab[1].

Financial Trajectory in Recent Years

Revenue Trends

In recent years, the revenue from Mavyret has shown a mixed trend. For Enanta Pharmaceuticals, which receives royalties from Mavyret sales, the total revenue for the twelve months ended September 30, 2023, was $79.2 million, down from $86.2 million in the previous year. This decline reflects the overall decrease in AbbVie's Mavyret sales[2].

Royalty Income

Enanta's royalty income from Mavyret has been a significant component of its revenue. However, the decline in Mavyret sales has impacted Enanta's financial performance, leading to a decrease in royalty revenue. Despite this, Enanta remains financially stable, with a focus on its RSV pipeline and other non-virology programs[2].

Global Market Outlook

Hepatitis C Drug Market

The global hepatitis C drug market, valued at $7.86 billion in 2018, is projected to reach $9.84 billion by 2032, with a CAGR of 1.8%. North America dominates this market, but there is significant growth potential in developing countries due to a large patient pool, although these markets are more reliant on subsidized drugs[5].

Key Takeaways

• Rapid Market Entry: Mavyret's competitive pricing and broad indication led to a swift capture of market share.
• Financial Performance: Initial sales exceeded expectations, but long-term growth is expected to slow due to a shrinking patient pool.
• Market Impact: Mavyret disrupted Gilead's dominance and contributed to the decline in Gilead's hepatitis C sales.
• Sustainability: AbbVie remains confident in Mavyret's long-term potential as part of its diversification strategy.
• Global Outlook: The hepatitis C market is expected to grow, albeit slowly, with significant potential in developing countries.

FAQs

Q: What is Mavyret, and how does it differ from other hepatitis C treatments?

Mavyret is a fixed-dose combination of glecaprevir and pibrentasvir, approved for the treatment of all six genotypes of hepatitis C. It differs from other treatments with its shorter 8-week treatment duration and lower pricing.

Q: How has Mavyret impacted the hepatitis C market?

Mavyret has significantly impacted the market by capturing a substantial share of new prescriptions, outpacing Gilead's Harvoni and Epclusa, and contributing to the decline in Gilead's hepatitis C sales.

Q: What are the long-term growth prospects for Mavyret?

Despite initial success, Mavyret's growth is expected to slow due to a shrinking patient pool. However, AbbVie remains confident in its long-term potential as part of its diversification strategy.

Q: How does Mavyret's pricing strategy compare to other hepatitis C treatments?

Mavyret was introduced at a significantly lower price point than Gilead's Sovaldi and Harvoni, making it a more affordable option for patients and payers.

Q: What other drugs contribute to AbbVie's growth strategy beyond Mavyret?

AbbVie's growth strategy includes other successful drugs like Imbruvica, Venclexta, and Orilissa, as well as experimental drugs such as upadacitinib and risankizumab.

Sources

1. Biopharma Dive: "AbbVie surprised investors with its hepatitis C success. Will it last?" - August 2, 2018
2. Business Wire: "Enanta Pharmaceuticals Reports Financial Results for its Fiscal Fourth Quarter and Year Ended September 30, 2023" - November 20, 2023
3. Fierce Pharma: "Dogged by AbbVie's new share-stealing Mavyret, Gilead's hep C guidance comes far short of expectations" - February 7, 2018
4. Enanta Pharmaceuticals: "Enanta Pharmaceuticals Reports Financial Results for its Fiscal Third Quarter" - August 5, 2024
5. Fortune Business Insights: "Hepatitis C Drug Market Size, Share - Industry Forecast, 2032"