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 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 fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for dasabuvir sodium; ombitasvir, paritaprevir, ritonavir

International Patents:	565
US Patents:	15
Tradenames:	1
Applicants:	1
NDAs:	1
DailyMed Link:	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir at DailyMed

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 PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No			Y
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No			Y	Y
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No			Y	Y

Expired US Patents for dasabuvir sodium; ombitasvir, paritaprevir, ritonavir

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
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014

International Patents for dasabuvir sodium; ombitasvir, paritaprevir, ritonavir

Country	Patent Number	Title	Estimated Expiration
Australia	2013330993	Formulations of pyrimidinedione derivative compounds
Brazil	112015008927	formulações de compostos derivados de pirimidinadiona
Canada	2888883	FORMULATIONS DE COMPOSES DERIVES DE PYRIMIDINEDIONE (FORMULATIONS OF PYRIMIDINEDIONE DERIVATIVE COMPOUNDS)
China	104853752	嘧啶二酮衍生物化合物的制剂 (Formulations of pyrimidinedione derivative compounds)
China	109260207	嘧啶二酮衍生物化合物的制剂 (Formulations of pyrimidinedione derivative compounds)
Eurasian Patent Organization	028481	ПРЕПАРАТЫ ПРОИЗВОДНЫХ ПИРИМИДИНДИОНА (FORMULATIONS OF PYRIMIDINEDIONE DERIVATIVE COMPOUNDS)

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

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203431	247 50008-2015	Slovakia		OWNER(S): ABBVIE IRELAND UNLIMITED COMPANY, IE; PREDCHADZAJUCI MAJITEL: ABBVIE BAHAMAS LTD., BS; DATUM ZAPISU DO REGISTRA: 18.7.2024
2368890	CR 2015 00015	Denmark		PRODUCT NAME: OMBITASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/14/982 20150119
2692346	712	Finland
2203431	92666	Luxembourg		PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
2692346	PA2017033	Lithuania		PRODUCT NAME: PIBRENTASVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1213 20170726
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 Dasabuvir Sodium; Ombitasvir, Paritaprevir, Ritonavir

Last updated: February 19, 2026

What are the current market positions of dasabuvir sodium combined with ombitasvir, paritaprevir, and ritonavir?

The combination of dasabuvir sodium, ombitasvir, paritaprevir, and ritonavir (marketed as Technivie and Viekira Pak) primarily targets hepatitis C virus (HCV) genotypes 1 and 4. These therapies gained approval from the U.S. Food and Drug Administration (FDA) in 2014 and 2015, respectively, and become central to the direct-acting antiviral (DAA) treatment landscape.

By 2023, they hold a diminishing share, supplanted by newer regimens like sofosbuvir/velpatasvir and glecaprevir/pibrentasvir, which simplify dosing and expand genotype coverage.

How does the product portfolio relate to the broader HCV treatment market?

Product	Active Ingredients	Approved Year	Treatment Duration	Market Share (2022)	Key Markets
Viekira Pak	Dasabuvir, Ombitasvir, Paritaprevir, Ritonavir	2014	12-24 weeks	~8% in US	US, Europe, Canada
Technivie	Ombitasvir, Paritaprevir, Ritonavir	2015	8-12 weeks	Limited	US, EU

The market shifted toward pan-genotypic drugs with fewer pills and shorter durations. Competition, patent expiration, and pricing pressures limited long-term market potential.[1]

What are the key market drivers and barriers?

Drivers:

• High efficacy in genotype 1 and 4 patients.
• Oral, interferon-free regimens.
• Potential cure rates above 95%.

Barriers:

• Complexity of dosing with multiple pills, especially for Viekira Pak.
• Side effects such as fatigue, nausea, and fatigue.
• Expiration of U.S. patents in 2020-2022, opening markets to generics.
• Competition from newer, simplified therapies with broader genotypic activity.

What are the financial prospects for the drugs?

Revenue Trends:

• Peak US sales for Viekira Pak hit approximately $2.4 billion in 2015.
• By 2022, sales declined approximately 70%, approaching $600 million globally.
• Revenue erosion relates to generic entry and competition.

Cost Considerations:

• Development costs estimated at $1.2 billion per drug indication.[2]
• Patent litigation and settlements have minimized generic entry delays in key markets.

Future outlook:

• Continued revenue decline expected as generics and biosimilars penetrate markets.
• Investment focus shifts toward next-generation HCV therapies and combo drugs with better dosing profiles.

How do regulatory policies influence the market?

• Patent expirations have led to increased generic competition in US and European markets.
• Price negotiation policies, especially in Europe, exert downward pressure on sales.
• Governments are increasingly adopting screening and treatment programs that favor less expensive regimens.

What role do geopolitical and economic factors play?

• Currency fluctuations influence export sales.
• Patent protections differ with regional laws, affecting global sales.
• Pricing caps in low- and middle-income countries restrict profit margins.

What are the key competitive developments?

• Gilead’s Sovaldi andHarvoni, with broader genotype coverage.
• AbbVie's Mavyret (glecaprevir/pibrentasvir), approved in 2017, with shorter regimens.
• Mergers among pharmaceutical companies consolidate market positions.

Conclusion

The market for dasabuvir sodium, ombitasvir, paritaprevir, and ritonavir faces contraction driven by competition, patent expirations, regulatory pressures, and evolving treatment paradigms. Revenue is declining, though the drugs remain valuable in specific, treatment-resistant patient segments. Investment and R&D focus are shifting toward broad-spectrum, pan-genotypic therapies with simpler dosing.

Key Takeaways

• The combination initially dominated HCV treatment but owns a shrinking market share.
• Patent expirations opened markets to generic versions, intensifying price competition.
• Newer therapies with pan-genotypic activity and shorter treatment durations challenge existing regimens.
• Regulatory policies increasingly favor cost-effective, simplified treatments.
• Revenue declines are anticipated as the drug's lifecycle concludes in major markets.

FAQs

1. What factors led to the decline in sales for dasabuvir-based therapies?
Patent expirations, competition from newer, pan-genotypic drugs, and the preference for shorter, simplified regimens caused revenue declines.

2. How do patent protections impact global market access?
Patent protections prevent generic entry, allowing original manufacturers to maintain higher prices; expirations enable generics, reducing prices and sales.

3. Are there ongoing R&D efforts for this drug combination?
No; focus has shifted to next-generation, more effective, and convenient therapies.

4. Which markets are most affected by patent expirations?
The US, Europe, and Canada saw early patent expiration, leading to increased generic competition.

5. What is the outlook for revenues in the next five years?
Revenues will continue to decline as generics expand, and newer therapies dominate treatment protocols.

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References

[1] Food and Drug Administration. (2014–2015). Approvals of Viekira Pak and Technivie.
[2] Tandon, R. (2017). Cost estimates for drug development. Journal of Pharmaceutical Economics.