Boceprevir - Generic Drug Details

What are the generic drug 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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for boceprevir

International Patents:	110
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	72
Patent Applications:	3,649
DailyMed Link:	boceprevir at DailyMed

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

Constraining patent/regulatory exclusivity:

7,772,178

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

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	7,012,066
Merck Sharp Dohme	VICTRELIS	boceprevir	CAPSULE;ORAL	202258-001	May 13, 2011	RE43298

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/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 boceprevir

Country	Patent Number	Title	Estimated Expiration
Japan	2013032389	NOVEL PEPTIDES AS NS3-SERINE PROTEASE INHIBITORS OF HEPATITIS C VIRUS
Spain	2572980
China	101792483
New Zealand	571073	Novel peptides as NS3-serine protease inhibitors of hepatitis C virus
Canada	2610167	ADMINISTRATION D'INHIBITEURS DE PROTEASE DU VHC EN COMBINAISON AVEC DES ALIMENTS POUR AMELIORER LA BIODISPONIBILITE (HCV PROTEASE INHIBITORS IN COMBINATION WITH FOOD)
Japan	2005524628
World Intellectual Property Organization (WIPO)	2006130628

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	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
1385870	12C0002	France		PRODUCT NAME: BOCEPREVIR OU UN ENANTIOMERE, STEREOISOMERE, ROTAMERE, TAUTOMERE OU RACEMATE DUDIT COMPOSE, OU UN DE SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/704/001 20110718

Boceprevir Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Boceprevir

Introduction

Boceprevir, marketed under the brand name Victrelis, is a hepatitis C virus (HCV) protease inhibitor that has played a significant role in the treatment of chronic HCV infection. Here, we delve into the market dynamics and financial trajectory of boceprevir, highlighting its impact, challenges, and the evolving landscape of HCV treatment.

Mechanism and Clinical Use

Boceprevir is a peptidomimetic ketoamide that inhibits the HCV NS3/4A protease, a crucial enzyme for the replication of the virus. It is administered orally every 8 hours with food to enhance exposure[4].

Clinical Efficacy

Boceprevir, when used in combination with peginterferon alfa and ribavirin, significantly improves the chances of achieving a sustained virologic response (SVR) in patients with chronic HCV. Clinical trials such as SPRINT-2 and RESPOND-2 have demonstrated its efficacy in both treatment-naive and treatment-experienced patients, particularly those with genotype 1 HCV[5].

Market Entry and Initial Impact

Boceprevir was approved by the FDA in 2011, marking a significant advancement in HCV treatment. Initially, it was used in combination with peginterferon alfa and ribavirin, offering a more effective treatment regimen compared to the previous standard of care.

Competition and Market Share

The HCV treatment market has been highly competitive, with several other direct-acting antivirals (DAAs) entering the market. Despite its initial success, boceprevir faced significant competition from other DAAs such as sofosbuvir (Sovaldi) and simeprevir (Olysio). Gilead's Sovaldi, in particular, dominated the market due to its higher efficacy and simpler treatment regimen, which did not require the use of interferon and ribavirin[3].

Financial Performance

The financial performance of boceprevir was impacted by its relatively short market dominance. While it generated significant revenue upon its launch, its market share was quickly eroded by newer, more effective treatments. Merck, the manufacturer of boceprevir, saw a decline in sales as other DAAs became more popular. For instance, in 2015, Gilead's Sovaldi and Harvoni captured the majority of the market, leaving competitors like Merck with a much smaller share[3].

Pricing and Access

One of the critical factors affecting the financial trajectory of boceprevir was its pricing strategy. The high cost of HCV treatments, including boceprevir, led to significant scrutiny from public health programs and insurers. While the list prices of these treatments were high, insurers often negotiated substantial discounts. However, the overall revenue per treatment remained substantial, with Gilead's average revenue per treatment for Sovaldi and Harvoni being around $54,000 in 2015[3].

Regulatory and Safety Considerations

The FDA has issued several safety communications regarding boceprevir, particularly concerning drug interactions with certain HIV protease inhibitors. These interactions have required careful management and monitoring, which could affect the drug's market appeal and usage[1].

Global Outlook and Market Dynamics

The global HCV treatment market has undergone significant changes in recent years. The introduction of pan-genotypic treatments and the elimination of ribavirin for certain patient groups have further complicated the market landscape. Despite these advancements, the overall patient population seeking HCV treatment is decreasing due to high treatment rates and low incidence rates, which threatens the sustainability of future HCV drug revenues[3].

Future Prospects

The future prospects for boceprevir are limited due to the dominance of newer DAAs. Merck has since shifted its focus to other treatments, such as Zepatier (grazoprevir/elbasvir), which has shown promise in treating patients with genotype 1 and 4 HCV. The competitive landscape, combined with the decreasing patient population, suggests that boceprevir will not regain its former market share[3].

Financial Burden and Accessibility

The financial burden of HCV treatments, including boceprevir, has been a significant issue. The high prices of these treatments have led to access restrictions, with many public payers and traditional insurance plans adopting measures to limit the number of patients who can benefit from these therapies. This has resulted in a situation where the financial returns of pharmaceutical companies are prioritized over accessibility and affordability[2].

Key Takeaways

• Clinical Efficacy: Boceprevir significantly improved SVR rates when used in combination with peginterferon alfa and ribavirin.
• Market Competition: Boceprevir faced intense competition from newer DAAs, leading to a decline in its market share.
• Financial Performance: Despite initial success, boceprevir's financial performance was impacted by the dominance of other DAAs.
• Pricing and Access: High treatment costs and access restrictions have been major challenges.
• Regulatory Considerations: Safety communications and drug interactions have affected its usage.
• Future Prospects: The market is now dominated by newer, more effective treatments, limiting boceprevir's future prospects.

FAQs

What is boceprevir used for?

Boceprevir is used to treat chronic hepatitis C virus (HCV) infection in adults, particularly those with genotype 1 HCV, in combination with peginterferon alfa and ribavirin.

How effective is boceprevir in treating HCV?

Boceprevir significantly improves the chances of achieving a sustained virologic response (SVR) when used in combination with peginterferon alfa and ribavirin, with SVR rates ranging from 63% to 66% in clinical trials.

Why did boceprevir lose market share?

Boceprevir lost market share due to the introduction of newer, more effective direct-acting antivirals (DAAs) such as sofosbuvir (Sovaldi) and simeprevir (Olysio), which offered simpler treatment regimens and higher efficacy.

What are the pricing challenges associated with boceprevir?

The high cost of boceprevir and other HCV treatments has led to significant scrutiny and access restrictions, with many public payers and insurers adopting measures to limit the number of patients who can benefit from these therapies.

What is the current status of boceprevir in the HCV treatment market?

Boceprevir is no longer a dominant player in the HCV treatment market, having been surpassed by newer DAAs. Merck has shifted its focus to other treatments like Zepatier (grazoprevir/elbasvir).

Sources

1. FDA: Victrelis (boceprevir) Information - FDA
2. HAL: Value, price and profits of hepatitis C antivirals and artemisinin-based
3. Drug Development: Recent Success in HCV Treatment Brings Relief to Patients but Challenges to Companies
4. ScienceDirect: Boceprevir - an overview | ScienceDirect Topics
5. Oxford Academic: Recent Successes and Noteworthy Future Prospects in the ...