Ombitasvir; paritaprevir; ritonavir - Generic Drug Details

What are the generic drug sources for ombitasvir; paritaprevir; ritonavir and what is the scope of patent protection?

Ombitasvir; paritaprevir; ritonavir is the generic ingredient in one branded drug marketed by Abbvie and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ombitasvir; paritaprevir; ritonavir has three hundred and ninety-three patent family members in forty-six countries.

Summary for ombitasvir; paritaprevir; ritonavir

International Patents:	393
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	41
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ombitasvir; paritaprevir; ritonavir
DailyMed Link:	ombitasvir; paritaprevir; ritonavir at DailyMed

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

Constraining patent/regulatory exclusivity:

8,691,938

Dosage:

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.

Recent Clinical Trials for ombitasvir; paritaprevir; ritonavir

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
South Valley University	Phase 4
Sohag University	Phase 4
Assiut University	Phase 4

See all ombitasvir; paritaprevir; ritonavir clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ombitasvir; paritaprevir; ritonavir

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for 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	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		DISCN	Yes	No	8,686,026		Y
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		DISCN	Yes	No	9,006,387
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		DISCN	Yes	No	8,642,538		Y	Y
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		DISCN	Yes	No	8,420,596*PED				Y
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		DISCN	Yes	No	8,691,938		Y	Y
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		DISCN	Yes	No	9,044,480

Expired US Patents for ombitasvir; paritaprevir; ritonavir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015	6,037,157*PED
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015	8,399,015*PED
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015	6,703,403*PED
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015	8,268,349*PED
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015	7,364,752*PED
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015	7,148,359*PED

EU/EMA Drug Approvals for ombitasvir; paritaprevir; ritonavir

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH Co. KG	Viekirax	ombitasvir, paritaprevir, ritonavir	EMEA/H/C/003839Viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.For hepatitis C virus (HCV) genotype specific activity.	Authorised	no	no	no	2015-01-14

International Patents for ombitasvir; paritaprevir; ritonavir

Country	Patent Number	Title	Estimated Expiration
Slovenia	2455376
Eurasian Patent Organization	024538
New Zealand	605550
Cyprus	2015012
Serbia	53856
Costa Rica	20140021
Croatia	P20140492

Supplementary Protection Certificates for ombitasvir; paritaprevir; ritonavir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2368890	C20150016 00154	Estonia		PRODUCT NAME: OMBITASVIIR;REG NO/DATE: EU/1/14/982 19.01.2015
2340029	599	Finland
2340029	PA2015011,C2340029	Lithuania		PRODUCT NAME: PARITAPREVIRAS; REGISTRATION NO/DATE: EU/1/14.982 20150115
2340029	CR 2015 00013	Denmark		PRODUCT NAME: PARITAPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEROF; REG. NO/DATE: EU/1/14/982 20150119
2692346	1790050-7	Sweden		PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/17/1213 20170728
2692346	122017000074	Germany		PRODUCT NAME: PIBRENTASVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1213 20170726
2340029	2015/011	Ireland		PRODUCT NAME: PARITAPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTRATION NO/DATE: EU/1/14/982 20150115

Ombitasvir; paritaprevir; ritonavir Market Analysis and Financial Projection

Last updated: February 14, 2026

What Are the Market Dynamics for Ombitasvir, Paritaprevir, and Ritonavir?

The combination of ombitasvir, paritaprevir, and ritonavir (often combined with dasabuvir) is primarily marketed under the brand name Viekira Pak and other formulations for hepatitis C virus (HCV) treatment. These drugs face competition from other direct-acting antivirals (DAAs), including sofosbuvir-based regimens.

The global HCV drug market experienced significant growth, driven by high demand for curative therapies, but has recently plateaued due to market saturation, generic entry, and declining HCV prevalence in some regions.

Market size and growth:

• The global hepatitis C treatment market was valued at approximately USD 8.6 billion in 2021, expected to reach USD 12 billion by 2026, growing at a CAGR of around 7%.
• The market is targeted primarily in North America, Europe, and Asia-Pacific, with the US accounting for over 40% of sales due to high prevalence and reimbursement policies.

Competitive landscape:

• Gilead Sciences and AbbVie dominate prominent markets with sofosbuvir-based regimens (Harvoni, Epclusa).
• Novartis’ combination (Vosevi) and Merck’s Zepatier are direct competitors.
• The emergence of generic versions and biosimilars in countries such as India and Egypt exerts pricing pressure.

Regulatory and patent factors:

• The original patents for Viekira Pak expired or are nearing expiry in several markets, leading to increased generic competition.
• Regulatory approvals vary by country; the U.S. FDA approved Viekira Pak in 2014, but its use has declined amid newer options.

How Has the Financial Trajectory Been Shaped?

Revenue Trends:

• Novartis reported peak sales of Viekira Pak at approximately USD 1.4 billion in 2015, with a steep decline thereafter as higher-efficacy, shorter-duration regimens gained popularity and patent expiry loomed.
• Gilead's Harvoni and Epclusa generated sales exceeding USD 20 billion globally during their peak years, overshadowing ombitasvir/paritaprevir/ritonavir formulations.

Profitability:

• High R&D costs and initial market exclusivity supported high margins early on.
• Patent expirations reduced pricing power, leading to revenue decline and lower margins for the drugs.
• Cost reductions through manufacturing efficiencies and generic competition further compressed profit margins.

R&D Investment:

• Novartis shifted R&D focus as market share declined, with resources reallocated to other therapeutic areas like cardiovascular and oncology.

Sales forecasts:

• Sales are expected to decline in mature markets but stabilize in emerging markets where patent protections remain, and generic versions are less prevalent.

Key Market Drivers and Barriers

Drivers	Barriers
High cure rates with short regimens	Patent expiry and patent challenges
Increased screening programs	Competition from newer, pan-genotypic regimens
Expansion in emerging markets	Price sensitivity and cost pressures for payers
Advancements in combination therapies	Regulatory hurdles and approval delays

What Is the Future Financial Outlook?

The outlook for ombitasvir, paritaprevir, and ritonavir is one of decline in developed markets as patent protections lapse and generics gain market share. In emerging markets, where regulatory and patent environments are less restrictive, sales may stabilize or grow slowly.

Key factors include:

• Patent expiration timelines, generally between 2018 and 2022 in many regions.
• Adoption of newer, pan-genotypic therapies that reduce the demand for earlier-generation regimens.
• Price erosion driven by generic entrants.

Key Takeaways

• The market for ombitasvir, paritaprevir, and ritonavir was profitable during patent exclusivity but is now in decline in developed markets.
• Competition from newer therapies and generics reduces pricing power and revenue.
• Emerging markets present opportunities for steady or growing sales due to less aggressive patent enforcement and unmet HCV treatment needs.
• R&D investments have shifted away from this combination due to market saturation and evolving standards of care.

FAQs

1. When do the patents for ombitasvir, paritaprevir, and ritonavir expire?
   Patents are expirying or have expired between 2018 and 2022 in various jurisdictions, depending on the country and specific patent protections.

2. Can generic versions significantly impact the market share of branded formulations?
   Yes. In markets like India and Egypt, generic versions have substantially reduced prices and market share of brand-name drugs.

3. What therapeutic alternatives are replacing this combination?
   Pan-genotypic regimens like sofosbuvir/velpatasvir and glecaprevir/pibrentasvir are preferred due to broader efficacy, shorter treatment durations, and improved side-effect profiles.

4. Are there ongoing research efforts for new formulations involving these compounds?
   Most research has shifted to newer compounds, but existing drugs are occasionally studied in combination with other agents for extended indications or improved outcomes.

5. How do regulatory policies influence the future of these drugs?
   Stringent patent protections and approval processes in certain markets can extend the commercial viability, while patent challenges and patent cliffs accelerate decline in others.

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Citations:

[1] MarketsandMarkets, "Hepatitis C Virus (HCV) Therapeutics Market," 2021.
[2] Gilead Sciences Annual Report 2021.
[3] Novartis Annual Report 2021.
[4] FDA approval documentation for Viekira Pak, 2014.