ombitasvir; paritaprevir; ritonavir - Profile

What are the generic drug sources for ombitasvir; paritaprevir; ritonavir and what is the scope of freedom to operate?

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ombitasvir; paritaprevir; ritonavir

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

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.

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			Y	Y
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		DISCN	Yes	No
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		DISCN	Yes	No
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		DISCN	Yes	No			Y
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		DISCN	Yes	No			Y	Y

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
European Patent Office	2853531	Composés antiviraux (Antiviral compounds)
Ukraine	105434	ТВЕРДА КОМПОЗИЦІЯ ТА СПОСІБ ЛІКУВАННЯ ВІРУСУ ГЕПАТИТУ С (SOLID COMPOSITION AND METHOD FOR TREATMENT OF HEPATITIS C)
Japan	2021035964	抗ウィルス化合物 (ANTI-VIRAL COMPOUNDS)
Uruguay	32699	COMPUESTOS ANTIVIRALES EFICACES PARA INHIBIR LA REPLICACIÓN DEL VIRUS DE LA HEPATITIS C ("HCV"), PROCESOS, COMPOSICIONES, Y MÉTODOS RELACIONADOS
Spain	2459390

Supplementary Protection Certificates for ombitasvir; paritaprevir; ritonavir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2340029	SPC/GB15/014	United Kingdom		PRODUCT NAME: PARITAPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTERED: UK EU/1/14/982 20150119
2368890	15C0016	France		PRODUCT NAME: OMBITASVIR DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/14/982 20150119
2340029	599	Finland
2692346	17C1040	France		PRODUCT NAME: PIBRENTASVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/17/1213 20170728
2692346	51/2017	Austria		PRODUCT NAME: PIBRENTASVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1213 (MITTEILUNG) 20170728

Summary
The fixed-dose combination of ombitasvir, paritaprevir, and ritonavir targets hepatitis C virus (HCV) infections. It received approval primarily for genotype 4 HCV, with extensions into genotype 1. Market valuation hinges on efficacy, resistance profiles, patent status, competition, and regulatory landscape. Investment prospects depend on the drug’s clinical positioning, patent life, and potential for market expansion.

Product Profile and Mechanism of Action
This combination combines three elements:

• Ombitasvir: NS5A inhibitor
• Paritaprevir: NS3/4A protease inhibitor
• Ritonavir: Pharmacokinetic enhancer (boosts paritaprevir levels)

It inhibits multiple stages of HCV replication, with a broad activity spectrum against genotypes 1 and 4. Approved by FDA (2015) and EMA (2016), it offers a shorter, well-tolerated treatment course (12-16 weeks), with sustained virologic response (SVR) rates over 90% in clinical trials.

Market and Competitive Dynamics

Measure	Details
Indication scope	Primarily genotype 4, with use in genotype 1 in combination regimens
Approved countries	US, EU, other major markets
Patent status	Patent expiry expected around 2027-2028; patent extensions possible through new formulations
Competitors	Sofosbuvir-based regimens (Epclusa, Harvoni), glecaprevir/pibrentasvir, voxilaprevir
Pricing	Launch price approximately $60,000-$80,000 for a 12-week course; discounts and negotiations are common

The drug faces competition from once-daily, pangenotypic regimens like glecaprevir/pibrentasvir and sofosbuvir/velpatasvir, which offer broader coverage and potential cost advantages.

Regulatory and Patent Environment

• Patent protections provide market exclusivity until approximately 2027-2028.
• Patent/IP challenges are unlikely to significantly impact existing patent life unless new formulations or delivery methods emerge.
• Regulatory pathways for additional indications would influence market penetration but are already well-established in HCV guidelines.

Financial and R&D Investment Fundamentals

• Development costs for HCV drugs typically range from $800 million to $1.2 billion, including clinical trials and regulatory filings.
• Revenue estimates for the drug depend on market penetration, pricing, and duration of use. Top-line peak sales could reach $500 million-$1 billion annually in targeted markets.
• Generic competition or biosimilar entry post-patent expiry could erode market share.

Clinical Data and Efficacy

• Trials report SVR12 rates exceeding 90% in genotype 4, with fewer side effects compared to earlier interferon-based therapies.
• Resistance profiles demonstrate high barriers, but genotypic resistance testing may influence treatment plans.
• Safety profile includes manageable side effects like fatigue, headache, and nausea; fewer adverse events cause treatment discontinuation.

Investment Risks and Opportunities

Risks:

• Patent expiration reduces exclusivity Prospects.
• Market shifts favor pangenotypic, shorter-course treatments.
• Pricing pressures from healthcare systems and emerging generics.

Opportunities:

• Expansion into additional HCV genotypes or co-infections.
• Development of new formulations with improved delivery (e.g., single-tablet regimens).
• Strategic licensing agreements or new patent filings extending market life.

Key Takeaways
The ombitasvir, paritaprevir, ritonavir combination holds a significant position in HCV treatment with high efficacy and tolerability. Market attractiveness is decreasing due to patent expiration and stiff competition. Biotech firms and pharmaceutical companies should monitor evolving generic landscapes and potential for new indications or formulations. Investment viability depends on structuring around exclusivity periods and pipeline diversification.

FAQs

Last updated: February 11, 2026

1. How long will the patent protection last for this combination?
   Patent expiration is expected around 2027-2028, with possible extensions for new formulations or indications.

2. Is the drug suitable for all HCV genotypes?
   Primarily effective for genotype 4; used in some genotype 1 regimens. It is not pangenotypic.

3. What are the main competitors?
   Sofosbuvir-based treatments like Epclusa and Harvoni, along with newer agents like glecaprevir/pibrentasvir.

4. What are the primary risks for investors?
   Patent expiry, competition from generics, market share erosion, and the shift toward pangenotypic regimens.

5. Are there opportunities for lifecycle extension?
   Yes, through new formulations, combination therapies, or expanding indications such as co-infections.

Sources
[1] U.S. Food and Drug Administration (FDA): Product labeling and approval history.
[2] European Medicines Agency (EMA): Marketing authorization details.
[3] Market research reports: Pricing and competition analysis.
[4] Clinical trial data: Published results from phase 3 HCV studies.
[5] Patent filings: Patent expiry estimates and legal landscape.

---