BOCEPREVIR - Generic Drug Details

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

Boceprevir is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Boceprevir has twenty-seven patent family members in seventeen countries.

Summary for BOCEPREVIR

International Patents:	27
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	72
DailyMed Link:	BOCEPREVIR at DailyMed

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

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 BOCEPREVIR

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

Sponsor	Phase
Dayanand Medical College and Hospital
American Research Corporation	Phase 4
Icahn School of Medicine at Mount Sinai	Phase 2/Phase 3

See all BOCEPREVIR clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BOCEPREVIR

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 BOCEPREVIR

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
Merck Sharp Dohme	VICTRELIS	boceprevir	CAPSULE;ORAL	202258-001	May 13, 2011		DISCN	No	No			Y

Expired US Patents for BOCEPREVIR

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

EU/EMA Drug Approvals for BOCEPREVIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp Dohme Ltd	Victrelis	boceprevir	EMEA/H/C/002332Victrelis 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 BOCEPREVIR

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1919478	COMBINAISON D'INHIBITEURS DE PROTEASE DE VHC ET D'UN SURFACTANT (COMBINATION OF HCV PROTEASE INHIBITORS WITH A SURFACTANT)
China	101212970	Combination of HCV protease inhibitors with a surfactant
Spain	2572980
Canada	2611155	FORMULATIONS PHARMACEUTIQUES ET METHODES DE TRAITEMENT UTILISANT CES FORMULATIONS (COMBINATION OF HCV PROTEASE INHIBITORS WITH A SURFACTANT)
European Patent Office	1891089	Inhibiteurs de protease du VHC en combinaison avec des aliments (HCV protease inhibitors in combination with food)
Australia	2006252553	Combination of HCV protease inhibitors with a surfactant
Taiwan	I380814

Supplementary Protection Certificates for BOCEPREVIR

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	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	SPC/GB11/057	United Kingdom		PRODUCT NAME: BOCEPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/704/001 20110720
1385870	C01385870/01	Switzerland		PRODUCT NAME: BOCEPREVIR; REGISTRATION NO/DATE: SWISSMEDIC 62105 31.10.2011
1385870	2011/038	Ireland		PRODUCT NAME: BOCEPREVIR OR AN ENANTIOMER, STEREOISOMER, ROTAMER, TAUTOMER OR RACEMATE OF SAID COMPOUND OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE OF SAID COMPOUND; REGISTRATION NO/DATE: EU/1/11/704/001 20110718
1385870	CA 2011 00036	Denmark		PRODUCT NAME: BOCEPREVIR ELLER EN ENANTIOMER, EN STEREOISOMER, EN ROTAMER, EN TAUTOMER ELLER ET RACEMAT AF DENNE FORBINDELSE, ELLER FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT AF DENNE FORBINDEL
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

Market Dynamics and Financial Trajectory for Boceprevir

Last updated: July 28, 2025

Introduction

Boceprevir, marketed as Victrelis®, is an oral protease inhibitor developed to treat chronic hepatitis C virus (HCV) infection, specifically genotype 1. Launched in 2011, Boceprevir marked a significant advancement in direct-acting antiviral (DAA) therapies but faced a competitive and rapidly evolving market landscape. Its market dynamics and financial trajectory offer valuable insights into the complexities faced by pharma companies in introducing novel antivirals amid shifting treatment paradigms and aggressive competition.

---

Pharmaceutical Profile and Market Entry

Boceprevir was developed by Merck & Co. as part of its effort to expand its antiviral portfolio. Designed as a first-generation HCV protease inhibitor, it was introduced as an add-on to interferon-based regimens and later as part of combination therapies aiming for improved sustained virologic response (SVR) rates. The approval by the FDA in 2011 enabled licensed use for specific patient populations following the failure of prior treatment regimens [1].

---

Market Dynamics

1. Competitive Landscape and Market Adoption

At launch, Boceprevir entered a saturated yet rapidly innovating HCV landscape. Prior to its approval, peginterferon and ribavirin constituted standard care, with limited efficacy and substantial side effects. The advent of Boceprevir promised higher cure rates, spurring initial market adoption. However, its market penetration was constrained by factors including:

• Limited efficacy compared to subsequent agents
  While initially promising, Boceprevir's SVR improvements were modest relative to later-generation DAAs, such as sofosbuvir and ledipasvir, which showcased higher SVR rates (up to 95-99%) [2].

• Complex treatment regimens and side effect profile
  Boceprevir regimens involved complex dosing, longer treatment duration, and significant adverse effects—including anemia and dysgeusia—dampening physician and patient enthusiasm.

• Emergence of superior therapies
  The rapid development and approval of second-generation DAAs radically changed the treatment landscape. These therapies offered interferon-free regimens with shorter durations and improved tolerability, rapidly overshadowing Boceprevir.

2. Pricing, Reimbursement, and Market Penetration

Pricing strategies influenced Boceprevir’s financial performance. Initially priced at approximately $48,000 for a 28-day supply, reimbursement policies varied across markets. The high cost limited affordability, especially in countries with strict price controls. As competitors launched more effective treatments, prices for Boceprevir-based regimens declined further, curbing revenue potential.

3. Patent Life and Market Longevity

Merck’s patent for Boceprevir was expected to provide exclusivity until late 2010s; however, the rapid shift to next-generation DAAs eroded its market longevity. Merck’s strategic focus shifted as the drug’s relevance waned, leading to phased reductions in marketing and distribution.

---

Financial Trajectory

1. Initial Revenue and Market Impact

Boceprevir experienced an optimistic launch, with initial sales contributing modestly to Merck’s antiviral segment. In its peak year (2012), Boceprevir generated approximately $250 million globally, representing a significant but limited slice of the overall HCV market [3]. This was in line with expectations based on the size of the treatment-naïve and treatment-failure patient populations.

2. Rapid Decline Due to Competitive Pressures

Within 2-3 years, sales rapidly declined following the introduction of better-tolerated, more effective regimens. By 2015, sales had plummeted, with Merck withdrawing the drug from several markets. The sector's pivot toward interferon-free, pan-genotypic therapies rendered Boceprevir essentially obsolete outside niche uses.

3. Discontinued Production and Patent Expiry

In 2017, Merck ceased marketing Boceprevir globally, citing market evolution and strategic realignment. The patent expiry had limited new revenue opportunities, and the company shifted resources toward next-generation antivirals and other therapeutic areas.

---

Market Trends and Future Outlook

While Boceprevir’s direct market trajectory was relatively short-lived, its development provided foundational insights for DAA combination strategies. The rapid successes of newer agents have reshaped expectations:

• Market consolidation and competition
  The dominance of products like sofosbuvir (Sovaldi®), ledipasvir/sofosbuvir (Harvoni®), and other pan-genotypic agents have decreased the market share and profitability of earlier agents like Boceprevir.

• Price erosion and affordability initiatives
  Generics and negotiations have driven prices down globally, impacting historical revenue streams.

• Pipeline implications
  The case of Boceprevir emphasizes the importance of early pipeline diversification and the need for continuous innovation in antiviral therapy.

---

Key Takeaways

• Rapid Innovation Necessitates Agile Strategies: The swift emergence of superior DAAs obsoleted Boceprevir within a few years, underscoring the importance of ongoing pipeline development and adaptability.

• Market Competition Drives Patent and Pricing Strategies: Competitive dynamics in HCV treatment significantly impact drug revenue, mandating robust intellectual property and marketing strategies.

• Efficacy and Tolerability Are Critical: Treatments offering higher SVR rates with fewer adverse effects outperform earlier agents, influencing prescribing behaviors and reimbursement decisions.

• Market Evolution Affects Financial Planning: Early investments in first-generation agents can yield limited returns if subsequent innovations rapidly supersede them.

• Strategic Exit and Portfolio Optimization: Pharmaceutical companies should evaluate lifecycle management and focus on high-potential next-generation therapies to sustain long-term profitability.

---

Conclusion

Boceprevir’s market journey epitomizes the volatile nature of antiviral therapeutics, where breakthroughs and competitors can rapidly reshape market structure and financial outcomes. Although its initial impact was notable, the acceleration of innovation and strategic shifts in HCV treatment have relegated Boceprevir to a historical footnote. Future success hinges on continuous innovation, agile commercialization, and anticipatory market analysis.

---

FAQs

1. Why did Boceprevir fail to sustain its market share?
Boceprevir was eclipsed by second-generation DAAs offering better efficacy, shorter treatment durations, and fewer side effects. The rapid advent of these therapies rendered Boceprevir obsolete within a few years.

2. How did pricing influence Boceprevir's financial performance?
Initially high-priced, Boceprevir faced price reductions amid competition and market saturation, limiting profit margins and market penetration.

3. What lessons can pharmaceutical companies learn from Boceprevir’s lifecycle?
Investing in continuous innovation, understanding competitive trends, and maintaining flexible pipeline strategies are critical for sustaining revenue streams beyond initial launches.

4. What role did patent expiry play in Boceprevir’s decline?
While patent expiry typically allows generic entry, the primary driver of decline was the emergence of superior alternatives, making generics less relevant for Boceprevir.

5. Are there any niche markets where Boceprevir still finds use?
Limited niche applications may exist in specific treatment-resistant cases or in regions lacking access to newer therapies, but overall, Boceprevir’s clinical utility has diminished significantly.

---

References

[1] Food and Drug Administration (FDA). "Victrelis (Boceprevir)." FDA, 2011.
[2] Feld, J. J., et al., "Sustained Virologic Response With Direct-Acting Antiviral Regimens for Chronic Hepatitis C," NEJM, 2015.
[3] IMS Health (IQVIA). "Global Sales Data for Hepatitis C Therapies," 2012-2015.