VIEKIRA PAK (COPACKAGED) Drug Patent Profile

Which patents cover Viekira Pak (copackaged), and when can generic versions of Viekira Pak (copackaged) launch?

Viekira Pak (copackaged) is a drug marketed by Abbvie and is included in one NDA. There are fifteen patents protecting this drug.

This drug has five hundred and sixty-five patent family members in fifty-two countries.

The generic ingredient in VIEKIRA PAK (COPACKAGED) is dasabuvir sodium; ombitasvir, paritaprevir, ritonavir. Additional details are available on the dasabuvir sodium; ombitasvir, paritaprevir, ritonavir profile page.

DrugPatentWatch^® Generic Entry Outlook for Viekira Pak (copackaged)

Viekira Pak (copackaged) was eligible for patent challenges on December 19, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 18, 2033. This may change due to patent challenges or generic licensing.

There have been fifteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for VIEKIRA PAK (COPACKAGED)

International Patents:	565
US Patents:	15
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	84
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIEKIRA PAK (COPACKAGED)
DailyMed Link:	VIEKIRA PAK (COPACKAGED) at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VIEKIRA PAK (COPACKAGED)

Constraining patent/regulatory exclusivity:

9,629,841

NDA:

206619

Dosage:

TABLET, TABLET;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.

US Patents and Regulatory Information for VIEKIRA PAK (COPACKAGED)

VIEKIRA PAK (COPACKAGED) is protected by fifteen US patents.

This potential generic entry date is based on patent 9,629,841.

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	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No	9,139,536
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No	9,006,387
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No	9,629,841		Y
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No	10,201,542		Y
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No	8,685,984

Expired US Patents for VIEKIRA PAK (COPACKAGED)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014	8,268,349
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014	6,037,157
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014	8,399,015
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014	7,364,752
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014	7,148,359

International Patents for VIEKIRA PAK (COPACKAGED)

When does loss-of-exclusivity occur for VIEKIRA PAK (COPACKAGED)?

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

Australia

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Japan

Mexico

Singapore

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 VIEKIRA PAK (COPACKAGED) around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	201300112	SOLID COMPOSITIONS
Serbia	57982	ČVRSTI SASTAVI (SOLID COMPOSITIONS)
Taiwan	201321002	Methods for treating HCV
Japan	5087409
Brazil	PI1004894	compostos antivirais

Supplementary Protection Certificates for VIEKIRA PAK (COPACKAGED)

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2340029	PA2015011	Lithuania		PRODUCT NAME: PARITAPREVIRUM; REGISTRATION NO/DATE: EU/1/14.982 20150115
2203431	PA2015013	Lithuania		PRODUCT NAME: DASABUVIRUM; REGISTRATION NO/DATE: EU/1/14/983 20150115
2368890	C02368890/01	Switzerland		FORMER OWNER: ABBVIE BAHAMAS LIMITED, BS
2692346	C20170036 00243	Estonia		PRODUCT NAME: PIBRENTASVIIR;REG NO/DATE: EU/1/17/1213 28.07.2017
2368890	CA 2015 00015	Denmark		PRODUCT NAME: OMBITASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/14/982 20150115

Market Dynamics and Financial Trajectory for VIEKIRA PAK (COPACKAGED)

Last updated: July 27, 2025

Introduction

VIEKIRA PAK, developed and marketed by AbbVie, is a combination antiviral therapy approved for treating chronic hepatitis C virus (HCV) infection. Comprising ombitasvir, paritaprevir (with ritonavir), dasabuvir, and sometimes ribavirin, VIEKIRA PAK marked a significant advancement in HCV treatment paradigms upon its launch. Its unique copackaged formulation simplifies therapy adherence, influencing both market dynamics and financial outcomes.

This report analyzes the factors shaping VIEKIRA PAK’s market trajectory, including its competitive positioning, patent landscape, regulatory developments, and financial performance. It further explores ongoing and potential future impacts driven by evolving treatment guidelines and technological innovations in HCV management.

Market Landscape and Competitive Positioning

The global HCV treatment market is highly competitive, driven by a rise in diagnosed cases and the pursuit of curative therapies. VIEKIRA PAK entered a market dominated by direct-acting antivirals (DAAs), including Gilead’s Harvoni (sofosbuvir/ledipasvir) and Epclusa (sofosbuvir/velpatasvir), as well as Merck's Zepatier (elbasvir/grazoprevir).

Market Differentiation:
VIEKIRA PAK's copackaged formulation offered a streamlined, once-daily, all-oral regimen, enhancing compliance—a critical factor in achieving sustained virologic response (SVR). However, its total treatment cost and complex patent ecosystem posed challenges. The formulation’s convenience increased its adoption among specific patient subsets, notably those with multiple comorbidities requiring a simplified regimen.

Pricing Strategy and Reimbursement:
Pricing variances across regions significantly influenced market penetration. The high cost of VIEKIRA PAK impacted payer acceptance, especially in markets where cheaper generics or alternative regimens emerged. Insurance and reimbursement policies in the US and Europe directly affected access and sales volumes.

Global Market Penetration:
North America remained the dominant market, owing to early approval and extensive diagnosis campaigns. Europe followed, with a growing presence in Asia and Latin America, where generic competition intensified. The shift toward pan-genotypic therapies, with broader efficacy and shorter durations, gradually eroded VIEKIRA PAK’s market share.

Patent Landscape and IPR Strategies

The longevity of VIEKIRA PAK's market exclusivity hinges on its patent estate. Key patents covering formulation, manufacturing processes, and compound combinations provided a protective barrier against generics. However, patent expirations and patent challenges in various jurisdictions threatened to dilute market exclusivity.

Patent Expirations and Challenges:
Notably, in the United States, certain patents began to expire around 2025, opening pathways for generic entrants. Legal disputes and patent challenges from competitors aimed to weaken exclusivity. As patent barriers weaken, revenue decline correlates with increased generic competition.

Patent Strategies:
AbbVie invested in supplementary patent filings covering improved formulations and delivery mechanisms to extend lifecycle. Such tactics delayed market entry of generics and maintained premium pricing windows, crucial for recouping high R&D investments.

Regulatory Developments and Market Impact

Regulatory agencies worldwide have progressively approved VIEKIRA PAK, with indications expanding to cover multiple genotypes and treatment-naive and experienced patients. Recent approvals of pan-genotypic, interferon-free regimens have shifted competitive dynamics.

Regulatory Approvals:
In countries with streamlined approval pathways, VIEKIRA PAK benefited from early registration, capturing initial market share. However, the introduction of more convenient regimens with shorter treatment durations posed a threat to its longstanding market position.

Treatment Guidelines:
Major hepatology associations update guidelines frequently. The inclusion of newer agents with superior tolerability, shorter durations, and broader genotypic efficacy has gradually relegated VIEKIRA PAK primarily to niche or resistant cases.

Financial Trajectory and Revenue Trends

VIEKIRA PAK initially generated blockbuster revenues, with peak sales attributed to its robust adoption in North America during 2015–2018. As newer regimens gained favor, revenues plateaued and subsequently declined.

Revenue Evolution:

• Initial Launch (2014-2016): Breakthrough sales driven by demand for highly effective, interferon-free therapy.
• Peak Period (2017-2019): Revenues exceeded $2 billion annually, reflecting widespread adoption.
• Post-2019 Decline: Revenue downturn observed as competition increased and patent challenges emerged; market share shifted towards pan-genotypic options such as Gilead's Epclusa and newer therapies like Mavyret.

Cost Structures and Margins:
VIEKIRA PAK's high R&D and manufacturing costs impacted profitability, especially as generics entered markets. Price reductions and increased market competition compressed profit margins. Nonetheless, the drug remained profitable during patent-protected periods.

Market Exit and Lifecycle Management:
AbbVie’s strategies entailed lifecycle extension through line extensions, reformulations, and combination therapies to prolong revenue streams. However, as global demand shifts toward newer, more convenient regimens, VIEKIRA PAK's financial trajectory faces inevitable decline absent new indications or formulations.

Emerging Factors Affecting Future Trajectory

Several factors will influence VIEKIRA PAK’s future market and financial prospects:

• Patent Expirations: As key patents lapse, generics will erode market revenues.
• Market Saturation and Competition: Pan-genotypic, shorter-duration regimens with improved tolerability are favored, reducing VIEKIRA PAK's market share.
• Regulatory and Reimbursement Policies: Favoring cost-effective, broad-spectrum therapies will accelerate its obsolescence in certain markets.
• R&D and Lifecycle Extensions: Potential for reformulation or combination drug development to sustain revenues.
• Global Access Initiatives: Extended access programs in developing markets can temporarily bolster sales but also heighten generic competition.

Conclusion

VIEKIRA PAK’s market dynamics reflect the typical lifecycle of high-efficacy, branded HCV therapies—initial rapid adoption driven by clinical advantages, followed by gradual decline amidst patent expiry, pricing pressures, and competition from pan-genotypic regimens. Financially, the drug transitioned from blockbuster status to market maturity stages, with revenues diminishing as the landscape shifts towards newer, more versatile therapies.

Recognizing these trends enables pharmaceutical companies and investors to navigate the evolving HCV treatment market, emphasizing the importance of strategic lifecycle management, patent protections, and innovation focusing on next-generation therapies.

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Key Takeaways

• VIEKIRA PAK initially revolutionized HCV treatment but faced stiff competition from other DAAs, impacting market share.
• Patent expirations and aggressive generic strategies will significantly reduce revenue, emphasizing the importance of patent estate management.
• Evolving treatment guidelines favor pan-genotypic regimens, further diminishing VIEKIRA PAK's long-term viability.
• Lifecycle extension approaches, including formulations and combinations, are critical to maintaining profitability.
• Market success relies heavily on regional reimbursement policies, pricing strategies, and global access initiatives.

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FAQs

1. What are the primary factors that contributed to the initial success of VIEKIRA PAK?
Its drug efficacy across multiple genotypes, simplified all-oral regimen, and favorable safety profile drove rapid adoption, particularly in North America and Europe.

2. How does patent expiry impact VIEKIRA PAK’s market?
Patent expiry opens the door for generic competitors, significantly reducing revenues as price competition intensifies and market share declines.

3. Can VIEKIRA PAK be repositioned or reformulated to extend its lifecycle?
Yes, lifecycle extension strategies include reformulations, combination therapies, or obtaining new indications, although success depends on regulatory approval and market acceptance.

4. What role do regulatory agencies play in shaping VIEKIRA PAK’s market?
Regulatory approvals determine its geographic availability; updates in treatment guidelines influence physician prescribing patterns and market demand.

5. What is the outlook for VIEKIRA PAK’s future revenue?
Expected to decline as competition intensifies and patent protections diminish unless offset by lifecycle extensions or niche applications in resistant or special populations.