Dasabuvir sodium; ombitasvir; paritaprevir; ritonavir - Generic Drug Details

What are the generic sources for dasabuvir sodium; ombitasvir; paritaprevir; ritonavir and what is the scope of freedom to operate?

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:

8,691,938

Dosage:

TABLET, EXTENDED RELEASE;ORAL

Constraining patent/regulatory exclusivity:

8,691,938

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	9,044,480
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No	10,105,365		Y
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No	8,685,984
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No	9,744,170		Y
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No	9,006,387

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	8,399,015
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	8,268,349
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
European Patent Office	3089757	FORMES GALÉNIQUES ANTIVIRALES SOLIDES (SOLID ANTIVIRAL DOSAGE FORMS)
Taiwan	201609195	Solid antiviral dosage forms
World Intellectual Property Organization (WIPO)	2015103490
Austria	E519746
Canada	2699986

Supplementary Protection Certificates for dasabuvir sodium; ombitasvir; paritaprevir; ritonavir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2692346	CR 2017 00049	Denmark		PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/17/1213 20170728
2368890	639	Finland
2692346	17C1040	France		PRODUCT NAME: PIBRENTASVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/17/1213 20170728
2692346	1790050-7	Sweden		PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/17/1213, 2017-07-28; SKYDDSTIDEN FOER FOELJANDE TILLAEGGSSKYDD HAR RAETTATS OCH FOERLAENGTS MED EN DAG, GENOM BESLUT AV PRV DEN 3 APRIL 2025. 2290023-7 2090010-6 1790051-5 2290023-7 2090010-6 1790051-5 1790050-7 1690006-0 1690045-8 1590072-3; SKYDDSTIDEN AER UTRAEKNAD I ENLIGHET ME 1690006-0 1690045-8 1590072-3; SKYDDSTIDEN AER UTRAEKNAD I ENLIGHET MED PATENT- OCH MARKNADSDOMSTOLENS BESLUT I PMAE 7804-24 OCH FRAMGAR AV SVENSK PATENTDATABAS.
2692346	LUC00038	Luxembourg		PRODUCT NAME: PIBRENTASVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1213 20170728

Last updated: February 14, 2026

Market Dynamics and Financial Trajectory for Dasabuvir Sodium, Ombitasvir, Paritaprevir, and Ritonavir

Current Market Overview

The combination of dasabuvir sodium, ombitasvir, paritaprevir, and ritonavir constitutes a multi-drug regimen primarily used to treat hepatitis C virus (HCV) infections. These drugs form the core of the fixed-dose combination marketed as Technivie and Viekira Pak, developed by AbbVie.

Market Size and Growth

As of 2022, the global hepatitis C treatment market is valued at approximately $11.5 billion. The market experienced rapid growth from 2014 onwards, driven by the introduction of direct-acting antivirals (DAAs). The market CAGR from 2019 to 2022 stands at around 8%.

The segment involving dasabuvir and associated drugs accounts for an estimated 15-20% of this market, equivalent to $1.7-$2.3 billion. Growth is expected to slow as the market approaches saturation in high-income countries and as newer therapies, including pangenotypic regimens, gain approval.

Competitive Dynamics

Key Players:

• AbbVie continues as the dominant manufacturer, with its Viekira Pak and Technivie offering.
• Gilead Sciences promotes alternatives like Harvoni and Epclusa, with broader pangenotypic efficacy.
• Merck and BMS are developing competing regimens, but none match the market penetration of Abbvie's combination.

Patent Status and Exclusivity:

• AbbVie's patents for Viekira Pak expire between 2025 and 2030, depending on jurisdiction.
• Patent expiry influences generic entry, which is expected to increase competitive pressures and lower prices.

Regulatory and Patent Landscape

• AbbVie's most recent patents extend into 2028-2030 in multiple jurisdictions.
• Patent litigations and challenges are active, aimed at invalidating patents or shortening exclusivity periods.
• The USFDA approved the specific regimen containing these drugs in 2014, with the European Medicines Agency (EMA) following suit in 2014-2015.

Pricing and Reimbursement Trends

Prices for these regimens ranged from $83,000 to $94,000 per treatment course in the US during 2014-2016. Reimbursement policies have since tightened:

• In the US, approvals are largely covered by Medicare and private insurers but involve strict inclusion criteria.
• Emerging markets see lower prices, often between $10,000 and $30,000, driven by generic competition.

Forecast and Potential Developments

New Approvals and Market Entry:

• Pangenotypic regimens such as Epclusa (sofosbuvir/velpatasvir) and Mavyret (glecaprevir/pibrentasvir) challenge the positioning of drugs based on dasabuvir and similar agents.
• No new formulations of dasabuvir-based combinations have gained approval since 2018, indicating market stagnation.

Pipeline and R&D:

• AbbVie is exploring next-generation HCV drugs with better efficacy and fewer side effects, but none specifically involve dasabuvir and the other existing combination drugs.
• Biosimilar development is limited due to complex patent landscapes and high development costs.

Market Trends:

• Shift toward pangenotypic regimens reduces dependence on genotype-specific drugs like the dasabuvir-based combinations.
• Price erosion due to patent expirations and generic entry emphasizes cost containment in treatment strategies.

Financial Trajectory

Revenue from dasabuvir and associated drugs is expected to decline gradually from its peak of over $600 million annually in the late 2010s to a projected $300–$400 million by 2025, as competition intensifies. Profit margins are forecasted to narrow as cheaper generics enter the market.

AbbVie's strategic response involves expanding into broader hepatitis C treatments and investing in R&D for next-generation antivirals. However, the core revenue stream from dasabuvir-based regimens appears to plateau or decline post-2025.

Key Takeaways

• The hepatitis C drug market is mature, with limited growth prospects for dasabuvir-based therapies.
• Patent expiry and competition from pangenotypic regimens will drive prices downward and erode market share.
• Abbott's current regimen faces increasing competition, pressure on pricing, and a shifting landscape favoring newer therapies.
• R&D focus is on novel antivirals, while existing regimens are increasingly regarded as legacy products.
• The global expansion into emerging markets faces challenges related to affordability and patent enforcement.

FAQs

1. When do patents for dasabuvir and related drugs expire?
Patents are expected to expire between 2025 and 2030, varying by jurisdiction and patent litigations.

2. What are the main competitors to dasabuvir-based regimens?
Pangenotypic regimens such as Epclusa (sofosbuvir/velpatasvir) and Mavyret (glecaprevir/pibrentasvir) dominate market share.

3. How has pricing changed since the initial launch?
Prices for these drugs peaked around $90,000 per treatment course during 2014-2016 but have decreased significantly due to generic competition and pricing pressures.

4. What is the outlook for revenue from dasabuvir-based therapies?
Revenue is projected to decline by roughly 50% over the next three years from its peak, influenced by patent expiry, competition, and market shift toward pangenotypic options.

5. Are there approved new formulations involving dasabuvir?
No new formulations or approvals involving dasabuvir have emerged after 2018, reflecting market obsolescence potential.

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Sources:

[1] MarketWatch. (2022). Hepatitis C treatment market size and forecast.
[2] FDA. (2014). Drug approval announcements.
[3] IQVIA. (2022). Global pharmaceutical pricing and reimbursement report.
[4] Abbott Laboratories. (2014). Viekira Pak product information.
[5] Statista. (2022). Global hepatitis C drug market data.