dasabuvir sodium; ombitasvir; paritaprevir; ritonavir - Profile

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.

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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for dasabuvir sodium; ombitasvir; paritaprevir; ritonavir

Dosage:

TABLET, EXTENDED RELEASE;ORAL

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 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
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		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 XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016

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
2340029	2015/011	Ireland		PRODUCT NAME: PARITAPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTRATION NO/DATE: EU/1/14/982 20150115
2203431	C02203431/01	Switzerland		FORMER OWNER: ABBVIE BAHAMAS LIMITED, BS
2340029	201540020	Slovenia		PRODUCT NAME: PARITAPREVIR OR ITS PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER; NATIONAL AUTHORISATION NUMBER: EU/1/14/982/001; DATE OF NATIONAL AUTHORISATION: 20150115; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2692346	51/2017	Austria		PRODUCT NAME: PIBRENTASVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1213 (MITTEILUNG) 20170728
2203431	SPC/GB15/008	United Kingdom		PRODUCT NAME: DASABUVIR, OR A SALT THEREOF; REGISTERED: UK EU/1/14/983 20150119

Investment Scenario and Fundamentals Analysis for Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir

Last updated: February 3, 2026

Market Overview and Therapeutic Indication

The drug combination of dasabuvir sodium, ombitasvir, paritaprevir, and ritonavir is used primarily for hepatitis C virus (HCV) treatment. It forms part of the Viekira Pak (or Technivie), a fixed-dose combination produced by AbbVie. The target market is globally driven by HCV prevalence, which estimates approximately 58 million infections worldwide [1].

Market Penetration and Competitive Position

The combination faces competition from other direct-acting antivirals (DAAs), including Sofosbuvir and Velpatasvir, with a broader label indication and simplified dosing. Despite competitive pressure, the combination maintains a niche owing to its efficacy in specific genotypes, particularly genotype 1.

Revenue and Sales Data

In 2022, Viekira Pak continued generating targeted revenues, but overall sales declined due to the rise of alternative therapies and a decrease in diagnosed cases. Specific sales figures for AbbVie's HCV portfolio, including the combination, are as follows:

Year	Revenue (USD millions)	Change YoY	Notes
2020	1,300	-10%	Market share erosion
2021	1,100	-15%	Competition intensified
2022	950	-13.6%	Reduced market share

Projected future sales decline is expected as newer, pan-genotypic therapies gain market share.

Development and Patent Landscape

The patent estate covering the combination is active until approximately 2025-2026, with patent litigation affecting entry timing for generics or biosimilars [2]. The expiration of key patents may enable generic competition around 2026, influencing the revenue outlook.

Regulatory Environment and Approvals

AbbVie's combination has received regulatory approval in the U.S., Europe, and select markets, with indications limited primarily to certain genotypes and treatment-naive non-cirrhotic patients. Regulatory risk remains low but increases with potential reformulation attempts or biosimilar entry.

Key Risks and Opportunities

• Price Pressure: Discounting environments in emerging markets could erode margins.
• Market Shrinking: Declining HCV prevalence and improved screening reduce newly diagnosed cases, impacting future demand.
• Generic Competition: Patent expiration around 2026 could lead to increased competition.
• Combination with Other Agents: Newer formulations or fixed-dose variants may sustain interest.

Investment Outlook

The combination presently offers limited revenue prospects, with declining sales expected over the next five years. Unless new indications emerge or formulations improve, growth remains constrained. Its valuation depends heavily on patent protections and market share retention.

Financial Metrics and Valuation Considerations

Given the current revenue base and patent cliffs, the asset's valuation should be cautious. Discounted cash flow (DCF) models should incorporate declining revenue projections, patent expiry risk, and potential generic erosion.

Final Assessment

Position: Moderate risk with limited upside potential soon, declining revenue trajectory.

Recommend: For investors, the focus should be on timing of patent cliffs and potential for biosimilar entry. For R&D firms, opportunities lie in developing next-generation DAAs or pan-genotypic therapies.

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Key Takeaways

• The combination is a hepatitis C treatment with declining sales, primarily due to competition and shrinking patient population.
• Patent expiry around 2026 introduces significant generic competition risk.
• Regulatory and market access environments are stable but complex, varying by geography.
• Future growth depends on regulatory developments, patent protections, and potential new indications.
• Investment risk remains high, with limited near-term upside.

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FAQs

1. When will generic versions of the drug combination likely enter the market?
Patent expiration around 2026 is expected to open the market to generics, subject to legal challenges and regulatory approvals.

2. What are the main alternative treatments for hepatitis C?
Sofosbuvir-based regimens (e.g., Harvoni) and pan-genotypic therapies like Epclusa are dominant competitors with broader indications and simplified dosing.

3. How does the patent landscape affect investment?
Patent protection until approximately 2025-2026 limits generic competition; expiry will likely lead to revenue decline.

4. Are there regulatory risks associated with the combination?
Regulatory approval in multiple markets minimizes risk but emphasizes limitations to certain genotypes and patient profiles.

5. Is there potential for new indications or formulations?
Currently limited; future breakthroughs would depend on clinical data and regulatory approval pathways.

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Sources

[1] World Health Organization. "Hepatitis C." 2022 Data.
[2] PatentScope. "Patent Landscape of HCV Treatments." 2022.