OMBITASVIR; PARITAPREVIR; RITONAVIR - Generic Drug Details

What are the generic sources for ombitasvir; paritaprevir; ritonavir and what is the scope of patent protection?

Ombitasvir; paritaprevir; ritonavir is the generic ingredient in one branded drug marketed by Abbvie and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ombitasvir; paritaprevir; ritonavir has four hundred and fifty-seven patent family members in forty-eight countries.

Summary for OMBITASVIR; PARITAPREVIR; RITONAVIR

International Patents:	457
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	41
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OMBITASVIR; PARITAPREVIR; RITONAVIR
DailyMed Link:	OMBITASVIR; PARITAPREVIR; RITONAVIR at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OMBITASVIR; PARITAPREVIR; RITONAVIR

Dosage:

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.

Recent Clinical Trials for OMBITASVIR; PARITAPREVIR; RITONAVIR

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

Sponsor	Phase
South Valley University	Phase 4
Sohag University	Phase 4
Assiut University	Phase 4

See all OMBITASVIR; PARITAPREVIR; RITONAVIR clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for OMBITASVIR; PARITAPREVIR; RITONAVIR

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for OMBITASVIR; PARITAPREVIR; RITONAVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		DISCN	Yes	No					Y
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		DISCN	Yes	No					Y
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		DISCN	Yes	No					Y
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		DISCN	Yes	No			Y	Y

Expired US Patents for OMBITASVIR; PARITAPREVIR; RITONAVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015

EU/EMA Drug Approvals for OMBITASVIR; PARITAPREVIR; RITONAVIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH Co. KG	Viekirax	ombitasvir, paritaprevir, ritonavir	EMEA/H/C/003839Viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.For hepatitis C virus (HCV) genotype specific activity.	Authorised	no	no	no	2015-01-14

International Patents for OMBITASVIR; PARITAPREVIR; RITONAVIR

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2651885	COMPOSÉS ANTIVIRAUX (ANTI-VIRAL COMPOUNDS)
Portugal	2579854
Israel	234781	תרכובות נגד נגיפים (Anti-viral compounds)
Japan	5534533

Supplementary Protection Certificates for OMBITASVIR; PARITAPREVIR; RITONAVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2340029	C20150019 00156	Estonia		PRODUCT NAME: PARITAPREVIIR;REG NO/DATE: EU/1/14/982 19.01.2015
2340029	92667	Luxembourg		PRODUCT NAME: PARITAPREVIR, OU UN SEL OU ESTER PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE (VIEKIRAX). FIRST REGISTRATION: 20150119
2368890	C20150016 00154	Estonia		PRODUCT NAME: OMBITASVIIR;REG NO/DATE: EU/1/14/982 19.01.2015
2340029	SPC/GB15/014	United Kingdom		PRODUCT NAME: PARITAPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTERED: UK EU/1/14/982 20150119

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Ombitasvir; Paritaprevir; Ritonavir

Last updated: July 28, 2025

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Introduction

The combination of ombitasvir, paritaprevir, and ritonavir (collectively marketed as Viekira Pak and other formulations) represents a significant therapeutic development targeting hepatitis C virus (HCV) infection. Since its approval, this drug combination has influenced both the landscape of antiviral treatment and the financial trajectories of pharmaceutical companies involved. This analysis explores the factors shaping its market dynamics and economic prospects, considering evolving clinical practices, competitive forces, regulatory environments, and the broader impacts on the healthcare industry.

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Market Landscape and Clinical Significance

HCV has historically posed a major global health burden, with over 71 million chronically infected individuals worldwide. The development of direct-acting antivirals (DAAs), including ombitasvir, paritaprevir, and ritonavir, revolutionized HCV therapy, offering cure rates exceeding 90%. The combination’s efficacy, especially against genotype 4 and other challenging strains, positioned it as a key option in the antiviral arsenal.

The drug's primary mechanism involves inhibiting viral protease activity (paritaprevir), with ombitasvir acting as an NS5A inhibitor — a critical viral replication component. Ritonavir, primarily a pharmacokinetic enhancer, boosts the levels and efficacy of paritaprevir. The synergy among these agents set a new standard of care, initially capturing substantial market share.

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Regulatory Milestones and Market Penetration

The U.S. Food and Drug Administration (FDA) approved this combination in late 2014, with subsequent approvals across Europe and other key markets. Early market entry benefited from its high efficacy, especially in treatment-experienced patients and those with cirrhosis, providing a viable alternative to interferon-based regimens.

However, rapid evolution in the HCV treatment landscape, notably the advent of pan-genotypic regimens such as sofosbuvir/velpatasvir, dented market share. Nonetheless, abbvie, the original developer, maintained a competitive edge through strategic formulation improvements and expanding indications, securing a solid revenue base.

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Market Dynamics: Drivers and Challenges

Drivers:

• Clinical Effectiveness: High cure rates and shorter treatment durations boosted adoption.
• Regulatory Approvals: Expanded indications across genotypes increased patient population outreach.
• Pricing Strategies: Competitive pricing, patient assistance programs, and negotiations with payers facilitated broader access.
• Global Expansion: Entry into emerging markets—where HCV prevalence is high—created new revenue streams.

Challenges:

• Competition: The crowded DAA market comprises drugs like sofosbuvir-based therapies, glecaprevir/pibrentasvir, and others, leading to fierce price competition.
• Pricing Pressures: Payer negotiations and government price controls have constrained profit margins.
• Market Saturation: Many chronic HCV patients have already been diagnosed and treated, especially in developed countries.
• Generic Entry and Biosimilars: Patent expiry and biosimilar development threaten sustained revenue streams, particularly in emerging markets.

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Financial Trajectory and Revenue Trends

Historical Performance:

Abbvie reported peak revenues from Viekira Pak in the vicinity of $2.8 billion in 2015. However, subsequent years witnessed a decline, attributable to market saturation and competing therapies. In 2020, revenues substantially tapered, approaching $500-700 million globally, underscoring the impact of competition and shifting treatment paradigms.

Forecast and Future Outlook:

The long-term financial viability hinges on several factors:

• Market Penetration in Low-Income Countries: Continued access programs can sustain growth, given high HCV prevalence.
• Line Extensions and Improved Formulations: Updates offering better tolerability or simplified dosing could regain market interest.
• Portfolio Diversification: Incorporation into broader antiviral or combination regimens enhances value.
• Patent and Exclusivity Status: Patent protections, expected to expire circa 2023-2025 in key jurisdictions, will accelerate generic competition, reducing revenues unless new patents or formulations are secured.

Emerging Opportunities:

• HCV Reinfection and Retreatment: Specific subsets, such as patients with advanced fibrosis or retreatment needs, might extend revenue streams through targeted marketing.
• Combination with Novel Agents: Potential partnerships integrating ombitasvir, paritaprevir, and ritonavir with upcoming direct-acting antivirals could create new value propositions.

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Regulatory and Market Challenges

The dynamic regulatory environment influences future profitability. Governments’ push for biosimilars and generics, coupled with cost-containment policies, imposes downward pressure on prices. Moreover, the shift towards pan-genotypic regimens with simplified dosing diminishes the attractiveness of genotype-specific combinations like ombitasvir/paritaprevir/ritonavir.

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Competitive and Market Outlook

The future market landscape is characterized by:

• Consolidation: Smaller or less competitive agents face acquisition or market exit.
• Market Share Redistribution: Established players adapt strategies to maintain relevance.
• Innovation Focus: Development of next-generation regimens targeting resistant or hard-to-treat populations remains imperative.

Overall, while the initial blockbuster status of ombitasvir/paritaprevir/ritonavir is unlikely to be sustained, niche markets and specific patient populations may afford continued revenue, especially in underpenetrated geographies.

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Key Takeaways

• High initial market penetration was driven by exceptional efficacy, but subsequent competition has suppressed revenues.
• Patent expirations and biosimilar threats are imminent, necessitating strategic diversification for sustained profitability.
• Market saturation in developed regions shifts focus towards emerging markets, with regulatory and pricing hurdles.
• Innovations and formulation improvements could revive interest, but the landscape is increasingly dominated by pan-genotypic, simplified regimens.
• Long-term financial success depends on strategic positioning within high-need patient populations and geographic expansion.

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FAQs

1. What is the primary therapeutic advantage of ombitasvir, paritaprevir, and ritonavir combination therapy?
It offers high cure rates for hepatitis C, particularly genotype 4, with shorter treatment durations compared to interferon-based therapies, and has favorable safety profiles.

2. How does market competition impact the profitability of this drug combination?
Increased competition from newer, pan-genotypic DAAs and price negotiations have led to declining revenues, prompting companies to seek market share through formulation improvements and geographic expansion.

3. What are the key patent expiry timelines affecting this therapy?
Patents are expected to expire around 2023-2025 in major markets, opening the door for generic competition that could dramatically reduce prices and revenue.

4. Which regions represent growth opportunities despite market saturation in developed countries?
Emerging markets such as India, Africa, and Southeast Asia, where HCV prevalence is high, offer substantial growth potential due to limited access to existing treatments.

5. How might future developments in HCV treatment influence this drug’s market position?
Advances in pan-genotypic, simplified regimens and combination therapies could render genotype-specific drugs less competitive, urging the need for ongoing innovation and strategic positioning.

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References

[1] World Health Organization. “Hepatitis C Fact Sheet.” 2022.
[2] FDA. “Sovaldi (sofosbuvir) and other DAAs Approval History.” 2014-2022.
[3] Abbvie Annual Reports and Investor Presentations. 2014-2022.
[4] IQVIA Reports on Global Hepatitis C Market. 2022.
[5] MarketWatch and Bloomberg Industry Data. 2022-2023.