DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR - Generic Drug Details

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

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

Dasabuvir sodium; ombitasvir; paritaprevir; ritonavir has five hundred and fifty-two patent family members in fifty-two countries.

Summary for DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

International Patents:	552
US Patents:	18
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR
DailyMed Link:	DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR at DailyMed

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

Constraining patent/regulatory exclusivity:

9,333,204

Dosage:

TABLET, EXTENDED RELEASE;ORAL

Constraining patent/regulatory exclusivity:

9,629,841

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.

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

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

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 DASABUVIR SODIUM; 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	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No	8,420,596		Y	Y
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No	8,680,106
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No	8,466,159
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No	9,006,387
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No	8,686,026		Y

Expired US Patents for DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016	7,148,359
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016	8,399,015
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016	8,268,349
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016	7,364,752

International Patents for DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

Country	Patent Number	Title	Estimated Expiration
Taiwan	201102063	Anti-viral compounds
Hong Kong	1148273
Lithuania	C2203431
Guatemala	201100056B
Japan	2010539187

Supplementary Protection Certificates for DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2692346	PA2017033	Lithuania		PRODUCT NAME: PIBRENTASVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1213 20170726
2340029	122015000042	Germany		PRODUCT NAME: PARITAPREVIR; REGISTRATION NO/DATE: EU/1/14/982 20150115
2340029	15C0021	France		PRODUCT NAME: PARITAPREVIR DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/14/982 20150119
2340029	32/2015	Austria		PRODUCT NAME: PARITAPREVIR, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER ANNEHMBARER ESTER DAVON; REGISTRATION NO/DATE: (MITTEILUNG VOM 19.1.2015) EU/1/14/982 20150115
2692346	132017000122534	Italy		PRODUCT NAME: PIBRENTASVIR, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(MAVIRET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1213, 20170728

Market Dynamics and Financial Trajectory for the Combination Hepatitis C Therapy of Dasabuvir Sodium, Ombitasvir, Paritaprevir, and Ritonavir

Last updated: July 28, 2025

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Introduction

The pharmaceutical landscape for hepatitis C virus (HCV) treatments has undergone transformative shifts driven by advances in antiviral therapeutics. The drug combination comprising dasabuvir sodium, ombitasvir, paritaprevir, and ritonavir represents a pivotal development tailored to address persistent unmet medical needs. Understanding the market dynamics and financial trajectory of this combination therapy is vital for stakeholders seeking strategic positioning amid evolving competitive pressures, regulatory environments, and technological innovations.

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Pharmacological Profile and Therapeutic Significance

This quadruple regimen, marketed under the brand name Viekira Pak and other formulations, targets HCV genotype 1, one of the most prevalent and treatment-resistant strains globally. The combination leverages:

• Dasabuvir sodium: non-nucleoside NS5B polymerase inhibitor.
• Ombitasvir: NS5A replication complex inhibitor.
• Paritaprevir: NS3/4A protease inhibitor.
• Ritonavir: pharmacokinetic enhancer, boosting paritaprevir levels.

Together, they enable a high sustained virologic response (SVR) rate, effectively curing HCV in most cases with shorter treatment durations and fewer side effects than earlier regimens.

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Market Dynamics Influencing the Therapeutic Landscape

1. Evolving Patent and Regulatory Environment

Initially approved by the FDA in 2014, the combination's patent exclusivity is nearing its lifecycle peak, with patent protections and data exclusivity dictating pricing and market share ([1]). Patent expirations open avenues for generic competitors, compelling brand-name manufacturers to innovate or risk erosion of market dominance.

Regulatory pathways, including EMA and FDA approvals, influence market access. Recent approvals of second-generation pangenotypic regimens such as sofosbuvir/velpatasvir have broadened treatment options, often at reduced costs, intensifying competitive pressures on dasabuvir-based therapies.

2. Competitive Therapeutic Alternatives

The rise of pangenotypic regimens—such as Gilead Sciences' Epclusa and GSK's Mavyret—has shifted prescribing preferences toward broader-spectrum, cost-effective options. These competitors often have simplified dosing regimens, shorter durations, and better safety profiles.

Additionally, innovations in nucleotide analogs, long-acting injectables, and combination pills are reshaping treatment algorithms, possibly limiting the window for dasabuvir-based therapy to sustain market share.

3. Cost and Reimbursement Dynamics

Pricing strategies directly influence market adoption. Initially, dasabuvir-containing regimens commanded premium prices, justified by high cure rates and minimized side effects. However, payer pressure and cost-containment measures—including formulary restrictions and negotiated discounts—have reduced reimbursement margins.

Third-party payers favor therapies with demonstrated cost-effectiveness; thus, value-based pricing becomes essential for ongoing market access ([2]).

4. Geographic Market Penetration

The global hepatitis C market exhibits significant disparities. North America and Europe present high reimbursement levels, fostering robust sales for established drugs. Emerging markets, however, face challenges due to pricing constraints, regulatory hurdles, and distribution infrastructure limitations, curbing widespread adoption.

Efforts by manufacturers to localize manufacturing and reduce costs are key to expanding market presence in low- and middle-income countries (LMICs).

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Financial Trajectory: Revenue Opportunities and Challenges

1. Revenue Generation Post-Launch

Upon initial approval, dasabuvir-based regimens experienced rapid revenue growth, driven by their superior cure rates and shorter treatment durations. The global hepatitis C market peaked around $20 billion in 2018, with a significant share attributable to therapies like Viekira Pak ([3]).

However, patent expirations, subsequent generics, and competitive drugs have resulted in revenue plateaus or declines in mature markets, prompting companies to explore life-cycle management strategies.

2. Impact of Generic Competition

As patents expire, generic manufacturers enter markets, exerting downward pressure on prices and revenues. Such competition, coupled with increasing biosimilar and generic options, has notably impacted profits.

Manufacturers responding with alternative formulations, combination devices, and investment in R&D aim to mitigate revenue erosion.

3. Market Penetration in Developing Countries

In LMICs, pricing flexibility and the deployment of volunteer licensing agreements have facilitated access, fostering volume-based revenue growth despite lower per-unit prices. These markets present substantial potential for growth, provided regulatory and infrastructural barriers are addressed.

4. R&D and Pipeline Developments

Investments in next-generation antivirals, longer-acting formulations, and diagnostics influence long-term financial trajectories. Pertinent pipeline candidates aim to enhance patient adherence, ease of administration, and cost reductions, shaping future revenue streams.

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Regulatory and Market Access Strategies

Sustaining financial viability relies on effective regulatory navigation and market access strategies. These include:

• Accelerated approval pathways for breakthrough therapies.
• Partnerships with governments and NGOs for large-scale hepatitis C elimination programs.
• Pricing models aligned with healthcare budgets and epidemiological needs.

Engagement in real-world evidence generation enhances value propositions, promoting favorable reimbursement decisions.

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Future Market Outlook and Trends

1. Transition to Pangenotypic Regimens

The global shift toward pangenotypic therapies is expected to diminish demand for genotype-specific regimens. Companies are accelerating product development pipelines to introduce more versatile treatments.

2. Technological Innovations

Advances in diagnostic technologies and remote monitoring can improve treatment outcomes and streamline therapy delivery, impacting the market's structure.

3. Market Consolidation and Strategic Alliances

Mergers, acquisitions, and licensing agreements are prevalent as firms seek to consolidate market share, leverage technological synergies, and expand into new geographies.

4. Impact of Pricing and Access Initiatives

Global health initiatives aim to reduce hepatitis C prevalence through drug affordability and public health programs, influencing revenue potentials for proprietary therapies.

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Key Takeaways

• Market saturation and competition: Entry of generic and pangenotypic therapies threaten dasabuvir-based regimen revenues.

• Patent expiries and lifecycle management: Patents nearing expiry require strategic innovation to sustain revenues.

• Global health dynamics: Expanding access in LMICs offers growth opportunities but necessitate cost-optimization and strategic partnerships.

• Innovation-driven growth: Next-generation therapies and delivery systems are pivotal for future financial success.

• Regulatory and policy influences: Reimbursement policies and health initiatives significantly shape market trajectories.

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Conclusion

The long-term financial prospects for the dasabuvir sodium, ombitasvir, paritaprevir, and ritonavir combination are intricately tied to the broader evolution of hepatitis C therapeutics. While current revenues face headwinds from patent expiries and competitive innovations, targeted strategic positioning—such as pipeline diversification, expansion into underserved markets, and pricing strategies—can sustain profitability. Stakeholders must continually monitor technological advances, regulatory shifts, and market access landscapes to adapt effectively to this dynamic environment.

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FAQs

Q1. What are the main factors influencing the decline in revenue for dasabuvir-based hepatitis C therapies?
Patents nearing expiration, the advent of more effective pangenotypic drugs, generic competition, and evolving treatment guidelines favoring simpler regimens have collectively diminished the revenue potential of dasabuvir-based therapies.

Q2. How do patent protections impact the market trajectory of this combination?
Patent exclusivity grants temporary market dominance and pricing power. Once patents expire, biosimilar and generic options proliferate, leading to price erosion and reduced market share for the originator drug.

Q3. What strategies can pharmaceutical companies employ to prolong the commercial life of dasabuvir-based regimens?
Developing next-generation formulations, obtaining new patents for novel uses, expanding indications, and forging strategic partnerships for global distribution can extend commercial viability.

Q4. In which geographic markets do dasabuvir-based therapies see the highest growth potential?
While high-income countries maintain significant sales, emerging markets with developing healthcare infrastructure, especially in regions with high HCV prevalence, present growing opportunities through tailored access programs.

Q5. How might future technological innovations influence the market for hepatitis C treatments?
Advances like long-acting injectables, remote diagnostic tools, and improved adherence monitoring can enhance treatment outcomes, potentially shifting market dynamics toward more patient-friendly and cost-effective options.

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References

[1] U.S. Food and Drug Administration. Viekira Pak (paritaprevir, ombitasvir, and dasabuvir). 2014.

[2] World Health Organization. Hepatitis C elimination: a position paper. 2016.

[3] IQVIA. Global Hepatitis C Market Report; 2018.