VIEKIRA PAK (COPACKAGED) Drug Patent Profile

When do Viekira Pak (copackaged) patents expire, and what generic alternatives are available?

Viekira Pak (copackaged) is a drug marketed by Abbvie and is included in one NDA. There are fifteen patents protecting this drug.

This drug has five hundred and sixty-five patent family members in fifty-two countries.

The generic ingredient in VIEKIRA PAK (COPACKAGED) is dasabuvir sodium; ombitasvir, paritaprevir, ritonavir. Additional details are available on the dasabuvir sodium; ombitasvir, paritaprevir, ritonavir profile page.

DrugPatentWatch^® Generic Entry Outlook for Viekira Pak (copackaged)

Viekira Pak (copackaged) was eligible for patent challenges on December 19, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 18, 2033. This may change due to patent challenges or generic licensing.

There have been seventeen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for VIEKIRA PAK (COPACKAGED)

International Patents:	565
US Patents:	15
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIEKIRA PAK (COPACKAGED)

US Patents and Regulatory Information for VIEKIRA PAK (COPACKAGED)

VIEKIRA PAK (COPACKAGED) is protected by fifteen US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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
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
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

International Patents for VIEKIRA PAK (COPACKAGED)

When does loss-of-exclusivity occur for VIEKIRA PAK (COPACKAGED)?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Japan

Mexico

Singapore

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VIEKIRA PAK (COPACKAGED) around the world.

Country	Patent Number	Title	Estimated Expiration
Serbia	54282
Spain	2526908
South Korea	101429024
Denmark	2368890
Spain	2546767

Supplementary Protection Certificates for VIEKIRA PAK (COPACKAGED)

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2340029	PA2015011,C2340029	Lithuania		PRODUCT NAME: PARITAPREVIRAS; REGISTRATION NO/DATE: EU/1/14.982 20150115
2368890	300731	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2692346	17C1040	France		PRODUCT NAME: PIBRENTASVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/17/1213 20170728
2692346	PA2017033	Lithuania		PRODUCT NAME: PIBRENTASVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1213 20170726
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 VIEKIRA PAK (COPACKAGED)

Last updated: February 20, 2026

What Is the Current Market Position of VIEKIRA PAK?

VIEKIRA PAK, co-packaged as a direct-acting antiviral (DAA), is used for hepatitis C virus (HCV) treatment. It combines two drugs: ombitasvir with paritaprevir and dasabuvir. It gained regulatory approval in multiple markets, including the US, Europe, and Japan, primarily targeting genotype 1 HCV infections. The product was developed by AbbVie, which launched it in 2015.

Market penetration benefits from high efficacy, shorter treatment durations, and minimal side effects compared to prior regimens. As of 2022, VIEKIRA PAK remains a leading branded therapy for HCV genotypes 1 and 4, with competitive pressures from newer oral regimens and generic options.

What Are the Market Dynamics and Competitive Factors?

Market Size and Growth

• Global HCV population: Estimated at 71 million chronic cases (WHO, 2021).
• Treatment-naïve patients: Approx. 15 million eligible for interferon-free regimens.
• Market trend: Declining due to increasing generic options and improved affordability.

Competition

• Direct competition: Gilead's Epclusa (sofosbuvir/velpatasvir), Mavyret (glecaprevir/pibrentasvir), and Harvoni (ledipasvir/sofosbuvir).
• Generic presence: Growing in low- and middle-income economies; patent exclusivity for VIEKIRA PAK may expire soon depending upon jurisdiction.

Regulatory Landscape

• Patent expiry: VIEKIRA PAK's primary patents expire between 2023-2025 in key territories.
• Access programs: AbbVie has engaged in pricing and licensing agreements to expand access, especially in developing markets.

What Are the Key Financial and R&D Fundamentals?

Revenue and Market Penetration

• Revenue (2021): Estimated at approximately $1.2 billion globally.
• Market share: Estimated at 8-12% among branded HCV therapies in high-income markets.
• Pricing dynamics: Per-treatment costs range from $50,000 to $80,000, depending on region.

Development Pipeline and R&D Focus

• Backup strategies: AbbVie previously developed new pan-genotypic regimens; current R&D focuses on longer-term cures, resistant strains, and combination regimens.
• Pipeline expansion: Minimal new formulations for VIEKIRA PAK are expected due to market saturation and patent expiration.

Cost Structure and Margins

• Manufacturing costs: Estimated at 15-20% of wholesale price.
• Gross margins: Historically above 70%, subject to patent status and market competition.

What Is the Patent and Regulatory Outlook?

• Patent protection: Limited in key markets by 2023-2025.
• Generic threat: High in developing country markets with voluntary licensing agreements.
• Regulatory approvals: Maintained in major markets; any upcoming patent challenges or legal disputes could influence sales.

What Are the Investment Risks and Opportunities?

Risks

• Patent expiration: Patent expiry will likely lead to significant revenue decline unless generic competition is limited.
• Market shift: Adoption of newer, pan-genotypic regimens reduces demand for VIEKIRA PAK.
• Pricing pressure: Emerging price competition due to generics and biosimilars.

Opportunities

• Market expansion: Focus on underserved regions through licensing agreements.
• Combination therapies: Integration into broader HCV treatment protocols.
• Lifecycle management: Development of new formulations or fixed-dose combinations.

Key Financial Metrics Summary

Metric	2021 Estimate
Revenue	~$1.2 billion
Market share in branded HCV	8-12%
Gross margin	>70%
Patent expiry in major markets	2023-2025

Key Takeaways

• VIEKIRA PAK remains relevant primarily in high-income markets; exposure to patent cliffs is imminent.
• Competitive landscape shifting toward pan-genotypic regimens and generics.
• AbbVie’s strategic advantage relies on market access, existing customer base, and pipeline focus.
• Long-term growth prospects depend largely on licensing, market expansion, or lifecycle extension strategies.
• Revenue decline expected post-patent expiry without new formulations or indications.

FAQs

1. How soon will VIEKIRA PAK face generic competition?
Patent expiries expected between 2023 and 2025 in key markets, with generic versions already available in some low-income regions.

2. Is there potential for VIEKIRA PAK to expand into new indications?
No significant new indications are in late-stage development; the primary focus is on maintaining market share in existing indications.

3. How does VIEKIRA PAK compare to newer regimens?
It is less convenient and potentially less effective against resistant strains compared to newer highly pan-genotypic and shorter-duration regimens.

4. What is the impact of pricing and access programs?
Pricing reductions and licensing agreements help extend reach in emerging markets but limit revenue growth in developed markets.

5. What is AbbVie's strategy post-patent expiry?
Investing in pipeline expansion, licensing, and potentially formulating combination products to sustain revenue streams.

---

References

[1] World Health Organization. (2021). Hepatitis C. https://www.who.int/news-room/fact-sheets/detail/hepatitis-c [2] AbbVie. (2022). VIEKIRA PAK product information.
[3] EvaluatePharma. (2022). Hepatitis C Virus (HCV) market analysis.