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 seventeen patents protecting this drug.

This drug has six hundred and twenty-one patent family members in fifty-four 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 ten 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:	621
US Patents:	17
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	22
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 seventeen 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

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
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:

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
Singapore	171708	ANTI-VIRAL COMPOUNDS TO TREAT HCV INFECTION
Peru	20140835	COMPUESTOS ANTIVIRALES
Canada	2847910	COMPOSES ANTIVIRAUX (ANTI-VIRAL COMPOUNDS)
Hungary	E038073
European Patent Office	2583677	Procédés pour le traitement du VHC avec au moins deux agent antiviral à action direct, ribavirin mais sans interféron (Methods for treating HCV comprising at least two direct acting antiviral agent, ribavirin but not interferon.)

Supplementary Protection Certificates for VIEKIRA PAK (COPACKAGED)

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2368890	15C0016	France		PRODUCT NAME: OMBITASVIR DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/14/982 20150119
2692346	51/2017	Austria		PRODUCT NAME: PIBRENTASVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1213 (MITTEILUNG) 20170728
2340029	300730	Netherlands		PRODUCT NAME: PARITAPREVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER DAARVAN; REGISTRATION NO/DATE: EU/1/14/982 20150119
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	1790050-7/1791051-4	Sweden		PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.

VIEKIRA PAK (COPACKAGED) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VIEKIRA PAK (COPACKAGED)

Introduction

VIEKIRA PAK, a groundbreaking treatment for chronic genotype 1 hepatitis C, was approved by the U.S. FDA in December 2014. This copackaged regimen, developed by AbbVie, marked a significant advancement in the treatment of HCV, offering high cure rates and improved patient outcomes. Here, we delve into the market dynamics and financial trajectory of VIEKIRA PAK.

Clinical Efficacy and Approval

VIEKIRA PAK's approval was based on a robust clinical development program that included six pivotal Phase 3 studies and several Phase 2 trials. These studies demonstrated that VIEKIRA PAK cured 95-100% of GT1a and GT1b hepatitis C patients, including those with compensated cirrhosis, liver transplant recipients, and patients co-infected with HCV/HIV-1[1][4].

Market Impact

The introduction of VIEKIRA PAK significantly altered the hepatitis C treatment landscape. It offered a highly effective, interferon-free regimen, which was a major departure from the traditional treatments involving pegylated interferon and ribavirin. This shift was crucial for improving patient compliance and outcomes, especially for those who had failed previous treatments or had challenging conditions like cirrhosis or HIV co-infection[1][4].

Patient Access and Support Programs

AbbVie implemented several programs to ensure broad market access to VIEKIRA PAK. The AbbVie Patient Assistance Program provided medication at no cost to patients facing financial difficulties. Additionally, a co-pay assistance program was available for commercially-insured patients, reducing out-of-pocket costs to as little as $5 per month[1].

Financial Performance

Initial Launch and Sales

Following its approval, VIEKIRA PAK saw strong sales growth. In the fourth quarter of 2014, AbbVie reported significant revenue increases, partly driven by the launch of VIEKIRA PAK. The drug contributed substantially to AbbVie's revenue growth, with global VIEKIRA sales reaching $554 million in the fourth quarter of 2015[5].

Full-Year Financial Results

For the full year 2015, AbbVie reported adjusted net revenues of $22.859 billion, up 14.5% from the previous year. VIEKIRA PAK played a key role in this growth, contributing to the company's expanded adjusted operating margin and adjusted gross margin[5].

Quarterly and Annual Sales

In the fourth quarter of 2015, VIEKIRA PAK generated $554 million in global sales, contributing to AbbVie's overall revenue growth. This strong performance was part of a broader trend of increased sales for AbbVie's key products, including HUMIRA and IMBRUVICA[5].

Competitive Landscape

The approval of VIEKIRA PAK occurred in a competitive market with other HCV treatments emerging around the same time. However, VIEKIRA PAK's high cure rates, particularly in difficult-to-treat patient populations, helped it maintain a strong market position. The regimen's designation as a Breakthrough Therapy by the U.S. FDA further underscored its significance and market potential[1][4].

Safety and Tolerability

While VIEKIRA PAK demonstrated high efficacy, it also showed a favorable safety profile. Clinical trials indicated that most adverse events were mild to moderate, with less than 2% of patients permanently discontinuing treatment due to adverse events. Common side effects included rash-related events, bilirubin elevations, and decreases in hemoglobin levels, which were generally manageable and resolved with ongoing therapy[3].

Regulatory and Market Access

VIEKIRA PAK was granted priority review and designated as a Breakthrough Therapy, reflecting its potential to offer substantial improvement over available therapies. This designation facilitated quicker market access and highlighted the drug's importance in treating HCV[1][4].

Patient and Physician Adoption

The high cure rates and improved tolerability of VIEKIRA PAK led to rapid adoption by both patients and physicians. The regimen's ability to treat a broad range of genotype 1 patients, including those with cirrhosis and HIV co-infection, made it a preferred choice in clinical practice[1][4].

Financial Projections and Future Outlook

AbbVie's financial projections for 2016 reflected strong double-digit growth, partly driven by the continued success of VIEKIRA PAK. Despite the emergence of other HCV treatments, VIEKIRA PAK remained a significant contributor to AbbVie's revenue, underscoring its enduring market impact[5].

Key Takeaways

• High Efficacy: VIEKIRA PAK demonstrated cure rates of 95-100% in clinical trials, including in challenging patient populations.
• Strong Market Performance: The drug contributed significantly to AbbVie's revenue growth in the quarters and years following its approval.
• Patient Access Programs: AbbVie implemented various programs to ensure broad market access and affordability for patients.
• Competitive Advantage: VIEKIRA PAK's designation as a Breakthrough Therapy and its high cure rates helped it maintain a strong market position.
• Safety Profile: The regimen showed a favorable safety profile with manageable side effects.

FAQs

What is VIEKIRA PAK used for?

VIEKIRA PAK is used for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection.

What are the key components of VIEKIRA PAK?

VIEKIRA PAK consists of ombitasvir, paritaprevir, ritonavir tablets, and dasabuvir tablets.

What were the cure rates observed in clinical trials for VIEKIRA PAK?

In clinical trials, VIEKIRA PAK cured 95-100% of GT1a and GT1b hepatitis C patients, with less than 2% experiencing virological failure[1][4].

How did VIEKIRA PAK impact AbbVie's financial performance?

VIEKIRA PAK significantly contributed to AbbVie's revenue growth, with global sales reaching $554 million in the fourth quarter of 2015[5].

What patient populations benefited most from VIEKIRA PAK?

VIEKIRA PAK was particularly effective in treating patients with compensated cirrhosis, liver transplant recipients, and those co-infected with HCV/HIV-1[1][4].

What support programs were available for patients taking VIEKIRA PAK?

AbbVie offered a patient assistance program and a co-pay assistance program to ensure affordability for patients facing financial difficulties[1].

Sources

1. AbbVie Receives U.S. FDA Approval of VIEKIRA PAK™ (Ombitasvir, Paritaprevir, Ritonavir Tablets; Dasabuvir Tablets) for the Treatment of Chronic Genotype 1 Hepatitis C. PR Newswire.
2. AbbVie Reports Fourth-Quarter and Full-Year 2014 Financial Results. AbbVie Investors.
3. VIEKIRA PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets). FDA.
4. AbbVie Receives U.S. FDA Approval of VIEKIRA PAK™ (Ombitasvir, Paritaprevir, Ritonavir Tablets; Dasabuvir Tablets) for the Treatment of Chronic Genotype 1 Hepatitis C. AbbVie News.
5. AbbVie Reports Full-Year 2015 and Fourth-Quarter Financial Results. AbbVie Investors.