VICTRELIS Drug Patent Profile

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

Victrelis is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and ten patent family members in thirty-three countries.

The generic ingredient in VICTRELIS is boceprevir. Additional details are available on the boceprevir profile page.

DrugPatentWatch^® Generic Entry Outlook for Victrelis

Victrelis was eligible for patent challenges on May 13, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 11, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VICTRELIS

International Patents:	110
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	9
Patent Applications:	1,641
DailyMed Link:	VICTRELIS at DailyMed

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

Constraining patent/regulatory exclusivity:

7,772,178

NDA:

202258

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 VICTRELIS

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

Sponsor	Phase
Hoffmann-La Roche
UMC Utrecht	Phase 2
Radboud University	Phase 2

See all VICTRELIS clinical trials

US Patents and Regulatory Information for VICTRELIS

VICTRELIS is protected by three US patents.

This potential generic entry date is based on patent 7,772,178.

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
Merck Sharp Dohme	VICTRELIS	boceprevir	CAPSULE;ORAL	202258-001	May 13, 2011		DISCN	No	No	7,772,178		Y
Merck Sharp Dohme	VICTRELIS	boceprevir	CAPSULE;ORAL	202258-001	May 13, 2011		DISCN	No	No	8,119,602
Merck Sharp Dohme	VICTRELIS	boceprevir	CAPSULE;ORAL	202258-001	May 13, 2011		DISCN	No	No	RE43298		Y	Y

Expired US Patents for VICTRELIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	VICTRELIS	boceprevir	CAPSULE;ORAL	202258-001	May 13, 2011	7,012,066
Merck Sharp Dohme	VICTRELIS	boceprevir	CAPSULE;ORAL	202258-001	May 13, 2011	RE43298

EU/EMA Drug Approvals for VICTRELIS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp Dohme Ltd	Victrelis	boceprevir	EMEA/H/C/002332 Victrelis is indicated for the treatment of chronic hepatitis-C (CHC) genotype-1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.	Withdrawn	no	no	no	2011-07-18

International Patents for VICTRELIS

When does loss-of-exclusivity occur for VICTRELIS?

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

Argentina

Australia

Brazil

Canada

China

European Patent Office

Japan

Mexico

New Zealand

Norway

Peru

South Africa

South Korea

Spain

Taiwan

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 VICTRELIS around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2404189	НОВЫЕ ПЕПТИДЫ КАК ИНГИБИТОРЫ NS3-СЕРИНПРОТЕАЗЫ ВИРУСА ГЕПАТИТА C (NOVEL PEPTIDES AS INHIBITORS OF HEPATITIS C VIRUS NS3-SERINE PROTEASE)
World Intellectual Property Organization (WIPO)	2006130628
Brazil	0112540
Japan	4298289
Portugal	1481000
Germany	122012000004

Supplementary Protection Certificates for VICTRELIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1385870	C 2011 014	Romania		PRODUCT NAME: BOCEPREVIR(1R,2S,5S)-N-[3-AMINO-1-(CICLOBUTILMETIL)-2,3-DIOXOPROPIL]-3-[(2S)-2[[[(1,1-DIMETILETIL)AMINO]CARBONIL]AMINO]-3,3-DIMETIL-1-OXOBUTIL]-6,6-DIMETIL-3-AZABICICLO[3.1.0]HEXAN-2-CARBOXAMIDA; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/704/001; DATE OF NATIONAL AUTHORISATION: 20110718; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/704/001; DATE OF FIRST AUTHORISATION IN EEA: 20110718
1385870	1190037-0	Sweden		PRODUCT NAME: BOCEPREVIR ELLER EN ENANTIOMER, STEREOISOMER, ROTAMER, TAUTOMER ELLER RACEMAT AV NAEMNDA FOERENING ELLER ETT FARMACEUTISKT GODTAGBART SALT ELLER SOLVAT AV NAEMNDA FOERENING; REG. NO/DATE: EU/1/11/704/001 20110718
1385870	C01385870/01	Switzerland		PRODUCT NAME: BOCEPREVIR; REGISTRATION NO/DATE: SWISSMEDIC 62105 31.10.2011
1385870	300506	Netherlands		PRODUCT NAME: BOCEPREVIR, OF EEN ENANTIOMEER, STEREOISIOMEER, ROTAMEER, TAUTOMEER OF RACEMAAT VAN DIE VERBINDING, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/11/704/001 20110718
1385870	C300506	Netherlands		PRODUCT NAME: BOCEPREVIR, OF EEN ENANTIOMEER, STEREOISIOMEER, ROATMEER, TAUTOMEER OF RACEMAAT VAN DIE VERBINDING, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/11/704/001 20110718
1385870	SPC/GB11/057	United Kingdom		PRODUCT NAME: BOCEPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/704/001 20110720

VICTRELIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VICTRELIS

Introduction

VICTRELIS (boceprevir), developed by Merck, was a significant player in the treatment of chronic hepatitis C (HCV) when it was approved by the U.S. Food and Drug Administration in May 2011. Here, we will delve into the market dynamics and financial trajectory of VICTRELIS, highlighting its launch, market performance, and eventual discontinuation.

Approval and Initial Market Impact

VICTRELIS was approved for the treatment of chronic HCV genotype 1 infection in combination with peginterferon alfa and ribavirin. This approval marked a major advancement in HCV treatment, offering better outcomes for patients compared to previous therapies[1].

Strategic Agreements and Market Expansion

Merck entered into strategic agreements with Roche to improve the diagnosis, awareness, and treatment of HCV. These agreements included the co-promotion of VICTRELIS and educational initiatives for healthcare professionals and patients. This collaboration aimed to extend the reach of VICTRELIS to both developed and emerging markets globally[1].

Clinical Efficacy and Safety Profile

VICTRELIS was shown to be effective in clinical studies, particularly when used in a triple combination therapy regimen. However, it had a specific safety profile that required careful consideration, including potential drug-drug interactions and side effects such as fatigue, anemia, and nausea[1].

Market Performance

VICTRELIS saw significant sales in its initial years. In 2012, its sales peaked at roughly $502 million, making it a notable contributor to Merck's pharmaceutical revenue[4].

Competitive Landscape

The HCV market was highly competitive, with other major players like Gilead, Bristol-Myers Squibb, and Janssen. Despite its initial success, VICTRELIS faced challenges in maintaining market share due to the emergence of more advanced direct-acting antivirals (DAAs) like Sovaldi and Harvoni from Gilead. These newer treatments offered simpler regimens and higher cure rates, making them more attractive to both patients and healthcare providers[3].

Financial Challenges

The financial performance of VICTRELIS was impacted by several factors, including intense competition and pricing pressures. The launch of newer DAAs led to a decline in VICTRELIS sales, as these new treatments were often preferred due to their superior efficacy and convenience. Additionally, the overall HCV market dynamics, such as high treatment rates and low incidence rates, contributed to a declining patient population seeking treatment, further affecting VICTRELIS sales[3].

Discontinuation of US Sales

In January 2015, Merck announced the discontinuation of US sales of VICTRELIS. This decision was likely driven by the declining market share and sales figures, as well as the increasing competition from more effective and convenient DAA regimens[4].

Post-VICTRELIS Strategy

Following the discontinuation of VICTRELIS, Merck focused on developing and launching new HCV treatments. One notable example is Zepatier (grazoprevir/elbasvir), which was launched in 2016 and has been more successful in the market. Zepatier is a pan-genotypic DAA regimen that offers improved efficacy and safety profiles, making it a competitive option in the HCV treatment landscape[3].

Financial Trajectory Overview

• Peak Sales: VICTRELIS sales peaked in 2012 at $502 million.
• Decline: Sales declined significantly due to competition from newer DAAs.
• Discontinuation: US sales were discontinued in January 2015.
• Post-VICTRELIS Performance: Merck's subsequent HCV treatment, Zepatier, has performed better in the market, though it still faces intense competition[3][4].

Key Takeaways

• VICTRELIS was a significant advancement in HCV treatment but faced intense competition from newer DAAs.
• The drug's market performance was strong initially but declined rapidly due to competitive pressures.
• Merck's decision to discontinue US sales of VICTRELIS was a strategic move to focus on more competitive treatments like Zepatier.
• The HCV market continues to evolve, with a focus on pan-genotypic treatments and improved safety and efficacy profiles.

FAQs

What was VICTRELIS used for?

VICTRELIS (boceprevir) was used for the treatment of chronic hepatitis C genotype 1 infection in combination with peginterferon alfa and ribavirin.

Why was VICTRELIS discontinued in the US?

VICTRELIS was discontinued in the US due to declining sales and increasing competition from more effective and convenient direct-acting antivirals (DAAs).

What were the main competitors to VICTRELIS?

The main competitors to VICTRELIS included Sovaldi and Harvoni from Gilead, Daklinza from Bristol-Myers Squibb, and Olysio from Janssen.

What is the current state of Merck's HCV treatment portfolio?

Merck has shifted its focus to newer treatments like Zepatier (grazoprevir/elbasvir), which is a pan-genotypic DAA regimen offering improved efficacy and safety.

How has the HCV treatment market evolved since the launch of VICTRELIS?

The HCV treatment market has evolved significantly with the introduction of more effective and convenient DAAs, leading to higher cure rates and simpler treatment regimens. However, this has also resulted in intense competition and declining patient populations seeking treatment.

Sources

1. Merck and Roche Establish Strategic Agreements in Fight Against Chronic Hepatitis C - Merck News
2. Merck Announces Fourth-Quarter and Full-Year 2013 Financial Results - Merck News
3. Recent Success in HCV Treatment Brings Relief to Patients but Challenges to Companies - Drug Development
4. Out with the old: Merck discontinues US sales of hep C med Victrelis - BioPharma Dive