OMBITASVIR; PARITAPREVIR; RITONAVIR - Generic Drug Details

What are the generic 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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ombitasvir; paritaprevir; ritonavir has four hundred and fifty-three patent family members in forty-eight countries.

Summary for OMBITASVIR; PARITAPREVIR; RITONAVIR

International Patents:	453
US Patents:	8
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	8,691,938		Y	Y
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		DISCN	Yes	No	8,642,538		Y	Y

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	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/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 OMBITASVIR; PARITAPREVIR; RITONAVIR

Country	Patent Number	Title	Estimated Expiration
Poland	2692346
Poland	2628481
Poland	2954892

Supplementary Protection Certificates for OMBITASVIR; PARITAPREVIR; RITONAVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2340029	CR 2015 00013	Denmark		PRODUCT NAME: PARITAPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEROF; REG. NO/DATE: EU/1/14/982 20150119
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
2368890	C02368890/01	Switzerland		FORMER OWNER: ABBVIE BAHAMAS LIMITED, BS

OMBITASVIR; PARITAPREVIR; RITONAVIR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ombitasvir, Paritaprevir, and Ritonavir

Introduction

The combination of ombitasvir, paritaprevir, and ritonavir, marketed as Viekira Pak by AbbVie, has been a significant player in the treatment of chronic hepatitis C virus (HCV) infection since its approval in 2014. Here, we delve into the market dynamics and financial trajectory of this drug regimen.

Approval and Initial Market Impact

Viekira Pak was approved by the FDA in 2014 for the treatment of HCV genotype 1, marking a significant advancement in HCV therapy with its all-oral, interferon-free regimen[2][4].

Market Competition

The HCV treatment market is highly competitive, with several major pharmaceutical companies vying for market share. Gilead Sciences, with its drugs Sovaldi and Harvoni, has dominated the market. Despite this, AbbVie's Viekira Pak and other competitors like Merck's Zepatier have attempted to carve out their own niches. However, Viekira Pak faced challenges due to its complex dosing regimen and the need for different treatment approaches for GT1a and GT1b subgroups, which made it less appealing compared to the simpler, once-daily administration of Harvoni[2].

Pricing and Cost-Effectiveness

The pricing of Viekira Pak has been a critical factor in its market dynamics. The drug costs $83,319 for a 12-week course and $166,638 for a 24-week course. AbbVie justifies this pricing based on the overall market dynamics, the benefits to patients, and the value it brings to the healthcare system, including high cure rates and low discontinuation and relapse rates[4].

Studies have shown that Viekira Pak is cost-effective compared to traditional interferon-based therapies. For example, an economic evaluation published in PubMed indicated that ombitasvir/paritaprevir/ritonavir and dasabuvir ± ribavirin (OMB/PTV/r + DSV ± RBV) dominated other regimens in terms of cost-effectiveness, with incremental cost-effectiveness ratios of £13,864 and £10,258 per quality-adjusted life-year (QALY) for treatment-naive and treatment-experienced patients, respectively[3].

Financial Performance

AbbVie's financial reports reflect the impact of Viekira Pak on their revenue. In the third quarter of 2014, AbbVie reported adjusted earnings per share (EPS) of $0.89, which was above the previous guidance range. However, the specific financial contributions of Viekira Pak to AbbVie's overall revenue are not isolated in these reports. The drug's performance is part of the broader dyslipidemia and HCV treatment segments, which have seen significant revenue but also face intense competition[1].

Rebates and Negotiations

To enhance market access, AbbVie negotiated significant rebates with major pharmacy benefit managers like Express Scripts. These agreements have been crucial in making Viekira Pak more affordable and accessible to patients. For instance, the deal with Express Scripts helped drive down the effective price of Viekira Pak and other HCV treatments, demonstrating the power of competition in the marketplace[4].

Global Outlook and Market Dynamics

The global HCV treatment market has undergone a significant shift with the introduction of direct-acting antivirals (DAAs) like Viekira Pak. While these treatments have made HCV a curable disease, they also present challenges for companies due to intense competition and a declining patient population. The high treatment rates in many countries and the low incidence rates of new HCV cases mean that the market is expected to stabilize rather than expand, with prices likely to remain stable due to the lack of generic competition and the high value of these treatments[2].

Regulatory and Clinical Considerations

Despite its clinical efficacy, Viekira Pak has faced regulatory challenges, including an FDA warning about severe liver disease associated with its use. However, this has not significantly deterred its use, and the drug remains a viable option for HCV treatment[4].

Patient Population and Treatment Outcomes

The treatment outcomes for Viekira Pak have been favorable, with high sustained virologic response (SVR) rates. For genotype 1 treatment-naive HCV patients, the lifetime risk of decompensated liver disease, hepatocellular carcinoma, and death from liver disease is significantly reduced compared to older treatment regimens[3].

Future Prospects

The future prospects for Viekira Pak and similar DAAs are influenced by several factors, including the launch of new pan-genotypic drugs, the stability of prices, and the declining patient population. While the market is expected to remain competitive, the value that these treatments bring to patients and the healthcare system is likely to sustain their market presence. However, companies will need to navigate the challenges of a shrinking market and intense competition to maintain their market share[2].

Key Takeaways

• Market Competition: Viekira Pak faces intense competition from Gilead's Sovaldi and Harvoni, as well as other DAAs.
• Pricing and Cost-Effectiveness: The drug is priced high but is cost-effective compared to traditional therapies.
• Financial Performance: Contributes to AbbVie's revenue, though specific figures are not isolated.
• Rebates and Negotiations: Significant rebates have been negotiated to enhance market access.
• Global Outlook: The market is expected to stabilize with stable prices and a declining patient population.
• Regulatory and Clinical Considerations: Despite regulatory warnings, the drug remains clinically effective.

FAQs

What is Viekira Pak, and how is it used?

Viekira Pak is a combination of ombitasvir, paritaprevir, and ritonavir, used for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection. It is an all-oral, interferon-free regimen.

How does Viekira Pak compare to other HCV treatments in terms of cost?

Viekira Pak is priced similarly to other DAAs like Sovaldi and Harvoni but is considered cost-effective due to its high cure rates and low discontinuation and relapse rates.

What are the main challenges faced by Viekira Pak in the market?

The main challenges include intense competition from other DAAs, a complex dosing regimen, and a declining patient population due to high treatment rates.

How have rebates and negotiations impacted the market for Viekira Pak?

Rebates negotiated with pharmacy benefit managers like Express Scripts have made Viekira Pak more affordable and accessible, driving down the effective price of the drug.

What is the future outlook for Viekira Pak and similar DAAs?

The market is expected to stabilize with stable prices, and while new pan-genotypic drugs will be launched, the patient population is expected to decline, posing challenges for market growth.

Sources

1. AbbVie Reports Third-Quarter 2014 Financial Results - AbbVie News.
2. Recent Success in HCV Treatment Brings Relief to Patients but Challenges to Companies - Drug Development.
3. Economic evaluation of ombitasvir/paritaprevir/ritonavir and dasabuvir ± ribavirin - PubMed.
4. Pricing Pressures: How the Business of Medicine Affects the Price of Therapy - Healio.