VIEKIRA PAK (COPACKAGED) Drug Patent Profile

Which patents cover Viekira Pak (copackaged), and when can generic versions of Viekira Pak (copackaged) launch?

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 April 13, 2032. 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
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	72
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIEKIRA PAK (COPACKAGED)
DailyMed Link:	VIEKIRA PAK (COPACKAGED) at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VIEKIRA PAK (COPACKAGED)

NDA:

206619

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 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

Expired US Patents for VIEKIRA PAK (COPACKAGED)

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

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:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

France

Guatemala

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Netherlands

New Zealand

Norway

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Turkey

Ukraine

Uruguay

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
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)

Supplementary Protection Certificates for VIEKIRA PAK (COPACKAGED)

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203431	15C0013	France		PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
2340029	CA 2015 00013	Denmark		PRODUCT NAME: PARITAPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEROF; REG. NO/DATE: EU/1/14/982 20150115
2203431	CA 2015 00014	Denmark		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115
2203431	C20150015 00143	Estonia		PRODUCT NAME: DASABUVIIR;REG NO/DATE: EU/1/14/983 19.01.2015

Viekira Pak Market Dynamics, Financial Trajectory, Patents, and Generic Entry Risk

Last updated: August 9, 2026

Viekira Pak was AbbVie’s first major hepatitis C virus (HCV) product and generated roughly $1.6 billion in global net revenue in 2015, its first full commercial year. Revenue fell rapidly as HCV treatment shifted toward simpler pan-genotypic regimens, pricing pressure intensified, and AbbVie redirected demand toward Mavyret. AbbVie discontinued U.S. commercial sales of Viekira Pak and Viekira XR effective January 1, 2019. The product no longer has meaningful U.S. commercial relevance, although its market history remains important for assessing AbbVie’s HCV strategy, combination-drug patenting, and the speed of therapeutic substitution in specialty pharmaceuticals.

What is Viekira Pak and how did it work?

Viekira Pak is a copackaged oral regimen for chronic HCV infection. It contains four direct-acting antiviral agents:

Component	Pharmacologic role
Ombitasvir	NS5A inhibitor
Paritaprevir	NS3/4A protease inhibitor
Ritonavir	Pharmacokinetic enhancer
Dasabuvir	Non-nucleoside NS5B polymerase inhibitor

The regimen was approved by the U.S. Food and Drug Administration on December 19, 2014, for patients with genotype 1 chronic HCV infection, including patients with compensated cirrhosis in specified treatment settings. It was administered with or without ribavirin depending on the patient population and genotype 1 subtype.

Viekira Pak’s clinical value was based on high sustained virologic response rates without interferon. Its commercial limitations were the number of tablets, genotype restrictions, drug-interaction burden, ribavirin requirements for some patients, and a complex dosing schedule compared with later fixed-dose products.

When did Viekira Pak lose exclusivity?

Viekira Pak lost commercial exclusivity through a combination of patent expiry, regulatory competition, and product withdrawal rather than through a single generic-launch event.

The principal milestones were:

Date	Event
December 2014	FDA approved Viekira Pak
December 2014	U.S. launch began
2015	First full year of commercial sales
2015	FDA approved Technivie, another AbbVie HCV regimen containing ombitasvir, paritaprevir, and ritonavir
2016	FDA approved Zepatier and expanded competition in genotype-specific HCV treatment
May 2017	FDA approved Mavyret, AbbVie’s pan-genotypic HCV product
2017-2018	Mavyret increasingly replaced Viekira Pak within AbbVie’s HCV portfolio
January 1, 2019	AbbVie discontinued U.S. sales of Viekira Pak and Viekira XR
2020	AbbVie reported the end of Viekira Pak and Viekira XR sales in its financial disclosures

Viekira Pak did not receive five-year new chemical entity exclusivity because its active ingredients had been separately developed or previously approved in the relevant regulatory context. Its regulatory protection depended on combination-product exclusivity, patents, labeling restrictions, and commercial positioning.

What was the financial trajectory of Viekira Pak?

Viekira Pak reached peak sales quickly and then declined as the HCV market matured. AbbVie’s reported figures changed by reporting period and product classification, but the company’s annual reports show the following approximate trajectory:

Fiscal year	Approximate reported net revenue	Market interpretation
2014	About $0.2 billion	Partial launch year
2015	About $1.6 billion	Peak commercial year
2016	About $1.1 billion	Decline from competitive pricing and treatment mix
2017	About $0.9 billion	Continued substitution by Mavyret and newer regimens
2018	About $0.6 billion	Final full year before U.S. discontinuation
2019 onward	Minimal or no material U.S. revenue	Product discontinued in the U.S.

AbbVie described the 2016 decline as primarily driven by lower net pricing and reduced volume in the U.S. HCV market. By 2017 and 2018, the company’s HCV revenue was increasingly associated with Mavyret rather than Viekira Pak. The exact revenue amount attributable to the copackaged Viekira Pak product can vary because AbbVie’s reporting sometimes grouped Viekira Pak, Viekira XR, and related HCV products in regional or product-category disclosures.

Viekira Pak revenue versus AbbVie’s HCV franchise

The relevant commercial shift was not simply loss of demand for HCV treatment. Patients continued to receive curative therapy, but the value moved from Viekira Pak to newer products.

Mavyret had several commercial advantages:

• Pan-genotypic labeling across major HCV genotypes.
• Eight-week treatment for many treatment-naive patients without cirrhosis.
• Lower treatment cost than several incumbent regimens.
• Simpler administration than Viekira Pak.
• Broader use across patient populations.
• A launch strategy designed for large payer and public-program contracts.

This created internal cannibalization. AbbVie accepted lower unit pricing for Mavyret in exchange for broader access and greater share of the remaining untreated HCV population.

What market forces caused Viekira Pak sales to decline?

HCV treatment became a short-duration, curative market

Direct-acting antivirals sharply reduced the duration and complexity of HCV treatment. This created an unusual commercial pattern: successful products rapidly reduced the pool of untreated patients. Once high-risk and highly motivated patients were treated, growth depended on diagnosis, screening, treatment of historically underserved populations, and payer access.

The market therefore shifted from premium pricing based on clinical transformation to competition based on treatment duration, genotype coverage, contracting, and budget impact.

Harvoni and Epclusa changed prescribing behavior

Gilead Sciences’ Harvoni and Epclusa established strong competitive benchmarks. Harvoni initially dominated genotype 1 treatment, while Epclusa offered broad genotype coverage. These products had strong physician familiarity, once-daily administration, and extensive clinical experience.

Viekira Pak’s regimen complexity made it less attractive as competitors offered simpler fixed-dose or once-daily alternatives.

Mavyret displaced Viekira Pak inside AbbVie

Mavyret was the most important direct commercial successor. Its approval in 2017 gave AbbVie a product that was more suitable for the mature HCV market. Mavyret competed not only against Gilead but also against Viekira Pak.

AbbVie’s product transition reduced the strategic value of maintaining a separate commercial infrastructure for Viekira Pak. The company’s 2018 decision to discontinue Viekira Pak and Viekira XR in the U.S. reflected portfolio rationalization rather than a failure of the underlying antiviral class.

Pricing pressure accelerated the decline

HCV payers increasingly used preferred formularies, rebate contracting, and treatment restrictions. State Medicaid programs and large insurers negotiated aggressively because several drugs offered comparable cure rates.

Viekira Pak’s price positioning became less defensible as Mavyret entered the market with a lower list price and a broad treatment label. The product’s revenue decline reflected both lower volume and reduced net price after rebates and discounts.

What was the FDA and Orange Book status of Viekira Pak?

The FDA approved Viekira Pak under the new drug application pathway for a specific HCV population. Its labeling included warnings involving hepatic decompensation, drug interactions, and interactions associated with ritonavir.

Viekira Pak was an FDA-approved branded product, not a biologic. Biosimilar regulation therefore does not apply. Any follow-on competition would proceed through the generic-drug framework, including an abbreviated new drug application where the applicant could establish pharmaceutical equivalence and bioequivalence.

The product’s historical Orange Book protection consisted of patents covering aspects of the antiviral agents, combinations, formulations, and treatment methods. Those listings did not create a durable barrier after commercial discontinuation. Since the product is no longer marketed in the U.S., the practical Orange Book question is less important than whether a generic applicant could establish a commercially viable market.

What patents protected Viekira Pak?

Viekira Pak was protected by a layered estate rather than by one patent directed to the package alone. The relevant categories included:

Patent category	Protected subject matter
Active-agent patents	Ombitasvir, paritaprevir, and dasabuvir compounds or compound classes
Combination patents	Use of multiple direct-acting antivirals in a coordinated regimen
Formulation patents	Solid dosage forms, excipients, particle properties, and tablet formulations
Manufacturing patents	Processes for producing active ingredients and intermediates
Method-of-use patents	Treatment of genotype 1 HCV and specific patient populations
Dosing patents	Regimens involving ribavirin, cirrhosis status, or treatment history

Patent protection was commercially stronger during the product’s launch period than it is today. The main barrier was the cumulative estate and the high technical burden of manufacturing multiple antiviral ingredients, not a single enduring formulation patent.

The patent estate also had limited long-term leverage because the therapeutic market moved quickly toward competing products with better convenience and broader labeling. A patent can delay substitution, but it cannot preserve market share when prescribers and payers have already shifted to another regimen.

Were there Paragraph IV challenges to Viekira Pak?

Publicly visible generic litigation did not become a major commercial event for Viekira Pak comparable to litigation surrounding high-revenue small-molecule medicines with long post-launch markets.

A Paragraph IV certification would require a generic applicant to assert that an Orange Book-listed patent is invalid, unenforceable, or not infringed. For a complex copackaged regimen, the applicant would face several issues:

1. Demonstrating equivalence for all relevant active ingredients.
2. Addressing multiple patents and patent families.
3. Matching the labeled combination and dosing requirements.
4. Resolving manufacturing and supply-chain complexity.
5. Entering a market in which the branded product was already being withdrawn.

The last point materially reduced the incentive to pursue a Viekira Pak generic. By the time commercial entry could have occurred, Mavyret and other pan-genotypic products had weakened the economic case for replicating the older regimen.

What generic entry risks exist for Viekira Pak?

Current U.S. generic-entry risk is commercially limited because Viekira Pak has been discontinued and the HCV market has moved to newer regimens.

Risk category	Assessment
U.S. Paragraph IV litigation	Low practical significance
Conventional generic substitution	Limited by product discontinuation and regimen complexity
Authorized generic risk	No material current commercial signal
International generic risk	Higher in countries with weaker or expired patent barriers
Therapeutic substitution	High; Mavyret and other pan-genotypic products already replaced the regimen
Manufacturing replication	Moderate to high technical complexity
Revenue exposure	Negligible for current AbbVie earnings

The principal competitive threat was therapeutic substitution, not a successful generic launch. A generic Viekira Pak could be legally possible in some jurisdictions while remaining commercially irrelevant in the U.S.

Which companies challenged or displaced Viekira Pak?

The principal competitive companies were:

Company	Product	Competitive effect
Gilead Sciences	Harvoni	Established a leading genotype 1 alternative
Gilead Sciences	Epclusa	Expanded pan-genotypic competition
Merck	Zepatier	Added another genotype-specific option
AbbVie	Mavyret	Replaced Viekira Pak within AbbVie’s own portfolio
Generic manufacturers	Potential follow-on products	Limited practical impact because of market withdrawal

The strongest displacement came from branded products with broader labels and simpler dosing, not from generic manufacturers.

How strong was the Viekira Pak patent estate?

The estate was commercially strong at launch but strategically short-lived.

Its strengths included:

• Multiple active pharmaceutical ingredients.
• Combination and treatment-method claims.
• Formulation and manufacturing layers.
• High development and regulatory complexity.
• Strong early market demand for interferon-free HCV treatment.

Its weaknesses included:

• Narrower genotype coverage than later products.
• Complex dosing.
• Rapid therapeutic innovation.
• High payer sensitivity.
• Internal substitution by Mavyret.
• A declining untreated-patient pool.
• Limited value in enforcing patents after discontinuation.

The estate protected an important commercial window, but it did not support a long product life cycle.

What licensing deals affected Viekira Pak?

Viekira Pak was developed through AbbVie’s internal HCV program and included antiviral assets associated with AbbVie’s research and external licensing or collaboration history. The commercial product was not principally defined by a high-profile third-party co-commercialization agreement comparable to some other HCV products.

AbbVie’s more important strategic transaction was its acquisition of Pharmacyclics in 2015, which was unrelated to Viekira Pak and did not drive the product’s HCV economics. For Viekira Pak, the core commercial issue was portfolio management: AbbVie moved investment and contracting support toward Mavyret as the more competitive product.

What litigation affected Viekira Pak?

Viekira Pak did not face a widely recognized U.S. patent-litigation campaign that materially prolonged its commercial life after the launch period. The product’s decline was driven primarily by market competition, pricing, prescribing convenience, and AbbVie’s own product transition.

The more important legal and regulatory issues were product labeling, safety warnings, patent-family management, and market-access contracting. Those issues did not generate a durable litigation-based extension of revenue.

How does Viekira Pak compare with Mavyret?

Attribute	Viekira Pak	Mavyret
Launch	2014	2017
HCV coverage	Primarily genotype 1	Pan-genotypic major HCV coverage
Dosing	Multiple tablets and scheduled doses	Three tablets once daily
Treatment duration	Often 12 or 24 weeks, depending on use	Often eight weeks for treatment-naive, noncirrhotic patients
Ribavirin use	Required in some populations	Generally avoided in many labeled populations
Market position	Early interferon-free regimen	AbbVie’s successor and primary HCV product
Commercial trajectory	Rapid peak followed by decline	Captured share as the market matured
U.S. status	Discontinued in 2019	Active commercial successor during the relevant period

Mavyret was better aligned with payer and prescriber requirements in the late-stage HCV market. Its lower treatment cost and broader label helped AbbVie preserve a presence in HCV after Viekira Pak’s decline.

What is the revenue exposure and investment significance?

Viekira Pak’s revenue exposure is now historical. At peak, the product represented a material contributor to AbbVie’s growth, but its decline had limited long-term impact because Mavyret replaced much of the company’s HCV commercial platform.

The financial lesson is that HCV products can produce rapid revenue concentration followed by equally rapid erosion. Key variables were:

• Speed of diagnosis and treatment uptake.
• Competitive cure rates.
• Net pricing after payer rebates.
• Treatment duration.
• Genotype coverage.
• Internal cannibalization.
• Remaining untreated population.
• Manufacturing complexity.

For investors and licensing teams, Viekira Pak is a case study in high initial demand without durable franchise economics. Its patent estate reduced early competitive risk, but it could not prevent displacement by a superior successor product.

Key Takeaways

• Viekira Pak was FDA approved in December 2014 for chronic genotype 1 HCV infection.
• It generated approximately $1.6 billion in 2015 revenue, its peak commercial year.
• Revenue declined to roughly $1.1 billion in 2016, about $0.9 billion in 2017, and about $0.6 billion in 2018.
• AbbVie discontinued U.S. sales of Viekira Pak and Viekira XR on January 1, 2019.
• Mavyret was the principal successor and displaced Viekira Pak within AbbVie’s portfolio.
• Generic entry was not the main cause of erosion; therapeutic substitution and pricing pressure were.
• Viekira Pak’s patent estate covered active ingredients, combinations, formulations, manufacturing, and treatment methods.
• The product has no meaningful current U.S. revenue exposure or biosimilar risk.
• Its commercial history shows how quickly a curative specialty-drug market can transition from premium pricing to payer-driven competition.

FAQs About Viekira Pak

Is Viekira Pak still available in the United States?

No. AbbVie discontinued U.S. commercial sales of Viekira Pak and Viekira XR effective January 1, 2019.

Is Viekira Pak the same as Mavyret?

No. Viekira Pak contains ombitasvir, paritaprevir, ritonavir, and dasabuvir. Mavyret contains glecaprevir and pibrentasvir and replaced Viekira Pak as AbbVie’s primary HCV product.

Does Viekira Pak have biosimilars?

No. Viekira Pak is a small-molecule antiviral regimen, so biosimilar regulation does not apply.

Why did AbbVie stop selling Viekira Pak?

AbbVie stopped selling the product because demand had shifted to newer, simpler, broader-coverage HCV regimens, particularly Mavyret. Pricing pressure and market maturation also reduced its commercial value.

Was Viekira Pak a commercial failure?

No. It was commercially successful at launch and generated peak annual revenue of approximately $1.6 billion. Its rapid decline reflected the normal evolution of the HCV market and replacement by a more competitive AbbVie product.

References

1. AbbVie Inc. (2015). 2015 annual report. AbbVie Inc.

2. AbbVie Inc. (2016). 2016 annual report. AbbVie Inc.

3. AbbVie Inc. (2017). 2017 annual report. AbbVie Inc.

4. AbbVie Inc. (2018). 2018 annual report. AbbVie Inc.

5. AbbVie Inc. (2019). 2019 annual report. AbbVie Inc.

6. U.S. Food and Drug Administration. (2014, December 19). FDA approves Viekira Pak to treat hepatitis C. U.S. Department of Health and Human Services.

7. U.S. Food and Drug Administration. (2017, August 3). FDA approves new drug to treat hepatitis C. U.S. Department of Health and Human Services.

8. U.S. Food and Drug Administration. (2020). Viekira Pak prescribing information. U.S. Department of Health and Human Services.