DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR - Generic Drug Details

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

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

Dasabuvir sodium; ombitasvir; paritaprevir; ritonavir has six hundred and eight patent family members in fifty-four countries.

Summary for DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

International Patents:	608
US Patents:	20
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR
DailyMed Link:	DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

Constraining patent/regulatory exclusivity:

9,333,204

Dosage:

TABLET, EXTENDED RELEASE;ORAL

Constraining patent/regulatory exclusivity:

9,629,841

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.

Anatomical Therapeutic Chemical (ATC) Classes for DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

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

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for DASABUVIR SODIUM; 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	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No	8,686,026		Y
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No	10,105,365		Y
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No	9,006,387
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No	8,188,104		Y	Y
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No	10,201,541		Y

Expired US Patents for DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016	7,148,359
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016	8,399,015
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016	8,268,349
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016	7,364,752

International Patents for DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

Country	Patent Number	Title	Estimated Expiration
Brazil	112014005617	tratamento de combinação (por exemplo, com abt-072 ou abt -333) de daas para uso no tratamento de hcv
Uruguay	33981	?MÉTODO PARA PREPARAR COMPUESTOS MACROCÍCLICOS INHIBIDORES DE SERINA PROTEASAS DE HEPATITIS C?.
South Africa	201203502	ANTI-VIRAL COMPOUNDS
South Korea	101831154
European Patent Office	3089757	FORMES GALÉNIQUES ANTIVIRALES SOLIDES (SOLID ANTIVIRAL DOSAGE FORMS)

Supplementary Protection Certificates for DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203431	1590018-6	Sweden		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
2368890	639	Finland
2692346	712	Finland
2203431	92666	Luxembourg		PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
2203431	C20150015 00143	Estonia		PRODUCT NAME: DASABUVIIR;REG NO/DATE: EU/1/14/983 19.01.2015

DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir

Introduction

Dasabuvir sodium, ombitasvir, paritaprevir, and ritonavir, collectively known as Viekira Pak, are a combination of direct-acting antivirals (DAAs) used for the treatment of chronic hepatitis C virus (HCV) infection. This combination therapy has been a significant player in the HCV treatment market since its approval.

FDA Approval and Regulatory Landscape

The FDA approved Viekira Pak in 2014 for the treatment of HCV genotype 1a and 1b infections, with or without compensated cirrhosis, and in combination with ribavirin for genotype 1a patients[5].

Market Entry and Initial Impact

Upon its market entry, Viekira Pak was one of the first all-oral, interferon-free treatments for HCV, marking a significant advancement in the treatment of this disease. This innovation led to a substantial shift in the HCV treatment paradigm, moving away from traditional interferon-based therapies.

Clinical Efficacy and Patient Outcomes

Clinical trials, such as the Phase 3b GARNET study, demonstrated high cure rates for Viekira Pak, with a 98% cure rate for patients with genotype 1b HCV[3]. This high efficacy rate contributed to its rapid adoption in clinical practice.

Market Competition

The HCV treatment market is highly competitive, with several other DAAs available, including those from Gilead Sciences (e.g., Sovaldi, Harvoni) and Merck (e.g., Zepatier). Despite this competition, Viekira Pak maintained a strong market presence due to its efficacy and the comprehensive nature of the treatment regimen.

Pricing and Reimbursement

The pricing of Viekira Pak has been a subject of discussion, particularly in the context of healthcare costs and access. Initially, the treatment was priced at a premium, reflecting its innovative nature and high efficacy. However, as more competitors entered the market, pricing pressures increased, leading to negotiations with payers and discounts to maintain market share.

Financial Performance

AbbVie, the manufacturer of Viekira Pak, reported significant revenue from the drug in the years following its approval. In 2015, Viekira Pak generated over $2 billion in sales, contributing substantially to AbbVie's revenue[4].

Market Expansion and Label Updates

In 2017, AbbVie received a positive opinion from the European Medicines Agency (EMA) for an eight-week treatment option with Viekira Pak for patients with genotype 1b HCV, further expanding its market potential[3].

Challenges and Decline

As the HCV treatment market evolved, newer therapies with simpler dosing regimens and broader genotypic coverage were introduced. This led to a decline in Viekira Pak's market share. Additionally, the increasing availability of generic versions of HCV treatments in some regions further eroded its market position.

Current Market Status

While Viekira Pak remains an approved and effective treatment for HCV, its market share has diminished due to the advent of newer, more convenient therapies. The drug is still used in certain clinical scenarios, particularly where its specific combination is preferred or required.

Key Interactions and Monitoring

The use of Viekira Pak involves careful monitoring due to potential drug interactions. For instance, co-administration with certain antibiotics, antifungals, and antidepressants can lead to significant changes in drug concentrations, necessitating dose adjustments or clinical monitoring[1].

Patient Access and Affordability

Efforts to improve patient access and affordability have been ongoing. AbbVie and other stakeholders have worked on pricing agreements and patient assistance programs to ensure that the treatment remains accessible to those in need.

Conclusion

The market dynamics and financial trajectory of Dasabuvir sodium, ombitasvir, paritaprevir, and ritonavir (Viekira Pak) reflect the evolving landscape of HCV treatment. From its initial success and high revenue generation to the challenges posed by newer therapies and generic competition, Viekira Pak has played a significant role in transforming the treatment of HCV.

Key Takeaways

• Innovative Treatment: Viekira Pak was one of the first all-oral, interferon-free treatments for HCV.
• High Efficacy: Demonstrated high cure rates in clinical trials.
• Market Competition: Faced intense competition from other DAAs.
• Pricing Pressures: Initial premium pricing followed by discounts and negotiations.
• Financial Performance: Generated significant revenue in the early years post-approval.
• Market Decline: Decline in market share due to newer therapies and generic competition.
• Current Status: Remains an approved treatment but with reduced market share.

FAQs

Q: What is Viekira Pak used for? A: Viekira Pak is used for the treatment of chronic hepatitis C virus (HCV) infection, specifically genotypes 1a and 1b.

Q: When was Viekira Pak approved by the FDA? A: Viekira Pak was approved by the FDA in 2014.

Q: What are the key components of Viekira Pak? A: The key components are dasabuvir sodium, ombitasvir, paritaprevir, and ritonavir.

Q: Why is monitoring important when using Viekira Pak? A: Monitoring is crucial due to potential drug interactions that can affect the concentrations of the components and other co-administered medications.

Q: How has the market share of Viekira Pak changed over time? A: The market share of Viekira Pak has declined due to the introduction of newer, more convenient HCV therapies and the availability of generic versions in some regions.

Sources

1. EMA Product Information: "Exviera - EPAR - Product Information" - European Medicines Agency.
2. FDA Draft Guidance: "Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir" - FDA.
3. AbbVie Press Release: "AbbVie Receives CHMP Positive Opinion for Eight-Week Treatment Option with Viekirax" - PR Newswire.
4. Australian Public Assessment Report: "Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as Sodium Salt) and Ribavirin" - Therapeutic Goods Administration.
5. Clinical Policy: "Dasabuvir/Ombitasvir/Paritaprevir/Ritonavir (Viekira Pak)" - Meridian Health Plan.