VIEKIRA XR Drug Patent Profile

When do Viekira Xr patents expire, and what generic alternatives are available?

Viekira Xr is a drug marketed by Abbvie and is included in one NDA. There are twenty patents protecting this drug.

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

The generic ingredient in VIEKIRA XR 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 Xr

Viekira Xr 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 January 2, 2035. This may change due to patent challenges or generic licensing.

There have been nine 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 XR

International Patents:	608
US Patents:	20
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Patent Applications:	22
Drug Prices:	Drug price information for VIEKIRA XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIEKIRA XR
DailyMed Link:	VIEKIRA XR at DailyMed

See drug prices for VIEKIRA XR

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

NDA:

208624

Dosage:

TABLET, EXTENDED RELEASE;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 VIEKIRA XR

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

Sponsor	Phase
Massachusetts General Hospital	Phase 4
University of Florida	Phase 4
Patient-Centered Outcomes Research Institute	Phase 4

See all VIEKIRA XR clinical trials

US Patents and Regulatory Information for VIEKIRA XR

VIEKIRA XR is protected by twenty 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 XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No			Y
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No			Y	Y
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No

Expired US Patents for VIEKIRA XR

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
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016
Abbvie	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016

International Patents for VIEKIRA XR

When does loss-of-exclusivity occur for VIEKIRA XR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

European Patent Office

Taiwan

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 XR around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2018065828	抗ウィルス化合物 (ANTI-VIRUS COMPOUND)
Japan	2008531565
Croatia	P20181819
New Zealand	592170	MACROCYCLIC HEPATITIS C SERINE PROTEASE INHIBITORS

Supplementary Protection Certificates for VIEKIRA XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2692346	C02692346/01	Switzerland		FORMER OWNER: ABBVIE BAHAMAS LTD., BS
2692346	712	Finland
2692346	PA2017033,C2692346	Lithuania		PRODUCT NAME: PIBRENTASVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1213 20170726
2692346	2017C/042	Belgium		PRODUCT NAME: PIBRENTASVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1213 20170728

VIEKIRA XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Viekira XR

Introduction to Viekira XR

Viekira XR, developed by AbbVie, is a significant advancement in the treatment of genotype 1 chronic hepatitis C (HCV), one of the most prevalent forms of the virus. This drug represents a crucial milestone in the evolution of HCV treatment, offering a once-daily, extended-release formulation that simplifies patient care.

Clinical Success and Approval

Viekira XR was approved by the U.S. Food and Drug Administration (FDA) in July 2016, marking a significant improvement over its predecessor, Viekira Pak. The new formulation combines dasabuvir, ombitasvir, paritaprevir, and ritonavir into a single-tablet regimen taken once daily with food, which is more convenient than the twice-daily administration of Viekira Pak[4][5].

Market Positioning

In the highly competitive HCV market, Viekira XR faces stiff competition from other direct-acting antivirals (DAAs), particularly from Gilead's Sovaldi and Harvoni. Despite this, Viekira XR has carved out a niche due to its efficacy and simplified dosing regimen. The drug has demonstrated high sustained virologic response (SVR) rates, with 100% SVR12 in GT1b patients and 95% SVR12 in GT1a patients when used with ribavirin[4].

Competitive Landscape

The HCV market is dominated by Gilead, with Sovaldi and Harvoni holding a significant market share. However, Viekira XR and other DAAs from companies like Merck (Zepatier) and Bristol-Myers Squibb (Daklinza) have been gaining ground. The competitive landscape is further complicated by pricing strategies, with Gilead's differential pricing of Sovaldi and Harvoni affecting market dynamics[1].

Pricing and Revenue

The pricing of Viekira XR is a critical factor in its market success. While the list price of HCV treatments is high, actual revenues are often lower due to discounts and rebates. For instance, Gilead's average revenue per treatment for Sovaldi and Harvoni was significantly lower than the list price, and similar discounts are expected for Viekira XR. The launch of Merck's Zepatier at a lower price point ($54,000 per treatment) has also influenced pricing dynamics, with AbbVie likely to offer competitive pricing to remain viable[1].

Financial Performance

AbbVie's financial performance from Viekira XR is closely tied to its royalty agreements and sales. Enanta Pharmaceuticals, which collaborates with AbbVie, reported significant royalty revenues from AbbVie's HCV regimens, including Viekira XR. In fiscal 2018, Enanta earned $191.6 million in per-product royalties on AbbVie’s net sales of its HCV regimens, including Viekira XR[2].

Market Challenges

Despite its clinical success, Viekira XR faces several market challenges. The high treatment rates in many countries have led to a decline in the patient population seeking treatment, which threatens the sustainability of future HCV drug revenues. Additionally, the lack of patent expirations for current DAAs in the near future means that generic competition will not drive down prices, but the overall market size is capped due to high treatment rates and low incidence rates[1].

Global Outlook

The global HCV market is expected to remain competitive, with new pan-genotypic drugs further diversifying and intensifying the market. However, the price erosion experienced in recent years is unlikely to continue, as market dynamics are inclined against significant price reductions. Viekira XR, along with other DAAs, will likely be priced at a premium relative to existing treatments, given the high efficacy and convenience they offer[1].

Patient Access and Assistance Programs

AbbVie has committed to ensuring patient access to Viekira XR through various assistance programs. Since the approval of Viekira Pak in 2014, AbbVie has supported access to medication for patients facing financial difficulties, and similar programs are in place for Viekira XR[4].

Future Prospects

The future prospects for Viekira XR are promising, given its clinical efficacy and the ongoing need for effective HCV treatments. As the market continues to evolve, AbbVie's focus on evolving its current therapies and investing in research and development will be crucial. The company's financial resources, bolstered by royalty revenues from its HCV regimens, will support these efforts[2].

Key Statistics and Trends

• SVR Rates: Viekira XR has demonstrated 100% SVR12 in GT1b patients and 95% SVR12 in GT1a patients when used with ribavirin[4].
• Market Share: Despite competition, Viekira XR is poised to capture a significant market share, particularly with the approval of its once-daily formulation[1].
• Pricing: The average revenue per treatment for HCV drugs, including Viekira XR, is lower than the list price due to discounts and rebates[1].
• Revenue: AbbVie's royalty revenues from its HCV regimens, including Viekira XR, have been substantial, with $191.6 million earned in fiscal 2018[2].

Expert Insights

"AbbVie's work continues to contribute to the transformation of hepatitis C care through our focus on evolving our current therapies as part of our ongoing commitment to patients," said Rob Scott, M.D., vice president, development and chief medical officer, AbbVie[4].

Conclusion

Viekira XR represents a significant advancement in HCV treatment, offering high efficacy and a simplified dosing regimen. Despite the competitive landscape and market challenges, Viekira XR is well-positioned to capture a substantial market share. The financial trajectory for Viekira XR is promising, driven by strong clinical data, competitive pricing, and AbbVie's commitment to patient access.

Key Takeaways

• Clinical Efficacy: Viekira XR has high SVR rates, making it a viable treatment option.
• Market Positioning: The drug faces competition but has a unique selling proposition with its once-daily dosing.
• Pricing Dynamics: Actual revenues are influenced by discounts and rebates.
• Financial Performance: Significant royalty revenues support AbbVie's financial health.
• Market Challenges: Declining patient population and capped market size due to high treatment rates.

FAQs

Q: What is Viekira XR, and how does it differ from Viekira Pak?

A: Viekira XR is a once-daily, extended-release formulation of the active ingredients in Viekira Pak, making it more convenient for patients.

Q: What are the SVR rates for Viekira XR?

A: Viekira XR has demonstrated 100% SVR12 in GT1b patients and 95% SVR12 in GT1a patients when used with ribavirin.

Q: How does Viekira XR compete in the HCV market?

A: Viekira XR competes with other DAAs, particularly Gilead's Sovaldi and Harvoni, but its once-daily dosing and high efficacy rates give it a competitive edge.

Q: What are the pricing dynamics for Viekira XR?

A: The actual revenue per treatment is lower than the list price due to discounts and rebates, similar to other HCV treatments.

Q: What support does AbbVie offer for patient access to Viekira XR?

A: AbbVie offers patient assistance programs to ensure access to medication for patients facing financial difficulties.

Cited Sources

1. Recent Success in HCV Treatment Brings Relief to Patients but Challenges to Companies - Drug Development.
2. 2018 Annual Report - Enanta Pharmaceuticals, Inc.
3. Medicines Use and Spending Shifts in the US in 2014 - IQVIA.
4. AbbVie Receives U.S. FDA Approval of Once-Daily VIEKIRA XR - AbbVie News.
5. Viekira XR (dasabuvir, ombitasvir, paritaprevir, and ritonavir) extended-release Tablets - FDA.