TECHNIVIE Drug Patent Profile

When do Technivie patents expire, and when can generic versions of Technivie launch?

Technivie is a drug marketed by Abbvie and is included in one NDA. There are eight patents protecting this drug.

This drug has four hundred and fifty-three patent family members in forty-eight countries.

The generic ingredient in TECHNIVIE is ombitasvir; paritaprevir; ritonavir. Additional details are available on the ombitasvir; paritaprevir; ritonavir profile page.

DrugPatentWatch^® Generic Entry Outlook for Technivie

Technivie 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 eight 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 TECHNIVIE

International Patents:	453
US Patents:	8
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
Drug Prices:	Drug price information for TECHNIVIE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TECHNIVIE
DailyMed Link:	TECHNIVIE at DailyMed

See drug prices for TECHNIVIE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TECHNIVIE

NDA:

207931

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 TECHNIVIE

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

Sponsor	Phase
AbbVie	Phase 3
AbbVie	Phase 2

See all TECHNIVIE clinical trials

US Patents and Regulatory Information for TECHNIVIE

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

Expired US Patents for TECHNIVIE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015

EU/EMA Drug Approvals for TECHNIVIE

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/003839 Viekirax 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 TECHNIVIE

When does loss-of-exclusivity occur for TECHNIVIE?

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 TECHNIVIE around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	344092	COMPUESTOS ANTIVIRALES. (ANTI-VIRAL COMPOUNDS.)
Spain	2414934
Serbia	57982	ČVRSTI SASTAVI (SOLID COMPOSITIONS)
France	17C1040
Australia	2009292182	Macrocyclic hepatitis C serine protease inhibitors

Supplementary Protection Certificates for TECHNIVIE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2340029	C20150019 00156	Estonia		PRODUCT NAME: PARITAPREVIIR;REG NO/DATE: EU/1/14/982 19.01.2015
2368890	122015000039	Germany		PRODUCT NAME: OMBITASVIR; REGISTRATION NO/DATE: EU/1/14/982 20150115
2692346	C201730039	Spain		PRODUCT NAME: PIBRENTASVIR O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1213; DATE OF AUTHORISATION: 20170726; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1213; DATE OF FIRST AUTHORISATION IN EEA: 20170726
2692346	132017000122534	Italy		PRODUCT NAME: PIBRENTASVIR, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(MAVIRET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1213, 20170728
2340029	32/2015	Austria		PRODUCT NAME: PARITAPREVIR, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER ANNEHMBARER ESTER DAVON; REGISTRATION NO/DATE: (MITTEILUNG VOM 19.1.2015) EU/1/14/982 20150115

TECHNIVIE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TECHNIVIE

Introduction to TECHNIVIE

TECHNIVIE, a combination of ombitasvir, paritaprevir, and ritonavir tablets, is a significant advancement in the treatment of chronic hepatitis C virus (HCV) infection. Approved by the U.S. Food and Drug Administration (FDA) in 2015, it is the first and only all-oral, interferon-free, direct-acting antiviral treatment for adult patients with genotype 4 (GT4) HCV infection who do not have cirrhosis[4].

Market Opportunity and Demand

The global antiviral drugs market, which includes treatments like TECHNIVIE, is experiencing robust growth. The market is estimated to be valued at USD 63.66 billion in 2024 and is projected to reach USD 89.95 billion by 2031, with a compound annual growth rate (CAGR) of 5.1% from 2024 to 2031. This growth is driven by increasing demand for broad-spectrum antiviral drugs and the impact of the COVID-19 pandemic on the pharmaceutical industry[1].

Target Patient Population

TECHNIVIE is specifically designed for patients with GT4 chronic HCV infection, a historically difficult-to-treat population. The approval of this drug has provided a curative therapy for these patients, significantly improving their treatment outcomes. The drug's efficacy is highlighted by the PEARL-I study, which demonstrated its ability to deliver a sustained virologic response (SVR) in patients[4].

Financial Impact and Pricing

The financial trajectory of TECHNIVIE is marked by its high treatment cost, which is a common challenge in the antiviral drugs market. A 12-week treatment course of TECHNIVIE costs approximately USD 76,653, making it one of the more expensive treatments for HCV. This high cost is a significant barrier for many patients, affecting the drug's market penetration and overall revenue[1][2].

Revenue and Sales Performance

Despite the high cost, TECHNIVIE has contributed to the substantial revenue generated by its manufacturer, AbbVie. The approval and subsequent sales of TECHNIVIE, along with other HCV treatments, have been part of a broader trend where pharmaceutical companies like Gilead Sciences have seen significant financial gains. For example, Gilead Sciences reported net product sales of $12.4 billion for its HCV drugs in 2014, and an additional $14.3 billion through the first nine months of 2015[2][5].

Regulatory Support and Designations

The FDA granted TECHNIVIE priority review and Breakthrough Therapy designation, which shortened the regulatory review period and highlighted its significant improvement in safety and effectiveness. These designations are crucial for accelerating the market entry of innovative treatments and can positively impact their financial performance by reducing the time to market[4].

Market Segmentation and Distribution

The distribution of antiviral drugs like TECHNIVIE is primarily through hospital pharmacies, which are estimated to hold 35.6% of the market share in 2024. Hospitals play a central role in treating serious viral infections, including HCV, due to the need for medical supervision and the administration of critical care antiviral regimens[1].

Geographical Market Dynamics

The Asia Pacific region is emerging as a significant market for antiviral drugs, driven by improving healthcare infrastructure, rising affordability, and increasing awareness about viral infection treatments. Countries like India, China, and Japan are key contributors to this growth, with India's large population and rising income levels benefiting pharmaceutical companies, and China leveraging its talent pool and cost advantages to produce affordable generic drugs[1].

Challenges and Barriers

Despite its market potential, TECHNIVIE faces several challenges, including its high treatment cost, which is a major barrier for many patients. The cost of hepatitis C treatments, in general, is a significant restraining factor for the antiviral drugs market. Additionally, the declining return on investment (ROI) for pharmaceutical R&D due to stricter regulatory hurdles and shorter exclusivity periods can impact the long-term financial sustainability of such treatments[1][3].

Future Outlook and Market Trends

The future outlook for TECHNIVIE and similar antiviral drugs is influenced by several trends. The increasing focus on combination therapies, which target multiple viral lifecycle stages or pathways, is expected to present lucrative opportunities. Technological advancements in drug delivery systems and the approval of new combination therapies will continue to shape the market. However, addressing the high cost of these treatments will be crucial for expanding their accessibility and market penetration[1].

Key Takeaways

• Market Growth: The global antiviral drugs market is projected to grow significantly, driven by increasing demand and technological advancements.
• High Treatment Cost: TECHNIVIE's high cost is a major barrier, affecting its market penetration and overall revenue.
• Regulatory Support: Priority review and Breakthrough Therapy designation by the FDA have accelerated its market entry.
• Geographical Dynamics: The Asia Pacific region is emerging as a key market due to improving healthcare infrastructure and rising affordability.
• Challenges: High treatment costs and declining ROI for pharmaceutical R&D are significant challenges.

FAQs

1. What is TECHNIVIE used for?

   • TECHNIVIE is used for the treatment of adults with genotype 4 (GT4) chronic hepatitis C virus (HCV) infection who do not have cirrhosis.

2. How much does a 12-week treatment course of TECHNIVIE cost?

   • A 12-week treatment course of TECHNIVIE costs approximately USD 76,653.

3. What regulatory designations has TECHNIVIE received?

   • TECHNIVIE received priority review and Breakthrough Therapy designation from the FDA.

4. Which market segment dominates the distribution of antiviral drugs like TECHNIVIE?

   • Hospital pharmacies dominate the distribution, holding 35.6% of the market share in 2024.

5. What are the main challenges facing the market for TECHNIVIE and similar antiviral drugs?

   • High treatment costs and declining ROI for pharmaceutical R&D are significant challenges.

Cited Sources

1. Coherent Market Insights - Antiviral Drugs Market - Price, Size, Share & Growth
2. GovInfo - THE PRICE OF SOVALDI AND ITS IMPACT ON THE U.S. HEALTH ...
3. DrugBank Blog - Investment Trends in Pharmaceutical Research
4. PR Newswire - TECHNIVIE™ (ombitasvir, paritaprevir, and ritonavir tablets ...
5. IL Farmacista Online - COMMITTEE ON FINANCE UNITED STATES SENATE ORRIN G ...