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QUVIVIQ Drug Patent Profile

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

Quviviq is a drug marketed by Idorsia and is included in one NDA. There are three patents protecting this drug.

This drug has eighty-eight patent family members in thirty-five countries.

The generic ingredient in QUVIVIQ is daridorexant hydrochloride. One supplier is listed for this compound. Additional details are available on the daridorexant hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Quviviq

Quviviq will be eligible for patent challenges on April 7, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 2, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for QUVIVIQ

International Patents:	88
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	1
Patent Applications:	5
Drug Prices:	Drug price information for QUVIVIQ
What excipients (inactive ingredients) are in QUVIVIQ?	QUVIVIQ excipients list
DailyMed Link:	QUVIVIQ at DailyMed

See drug prices for QUVIVIQ

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

NDA:

214985

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 QUVIVIQ

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

Sponsor	Phase
Idorsia Pharmaceuticals Ltd.	Phase 1

See all QUVIVIQ clinical trials

Pharmacology for QUVIVIQ

Drug Class	Orexin Receptor Antagonist
Mechanism of Action	Orexin Receptor Antagonists

US Patents and Regulatory Information for QUVIVIQ

QUVIVIQ is protected by three US patents and two FDA Regulatory Exclusivities.

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
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-001	Apr 7, 2022		RX	Yes	No			Y	Y
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-002	Apr 7, 2022		RX	Yes	Yes
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-001	Apr 7, 2022		RX	Yes	No
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-002	Apr 7, 2022		RX	Yes	Yes			Y	Y
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-001	Apr 7, 2022		RX	Yes	No

International Patents for QUVIVIQ

When does loss-of-exclusivity occur for QUVIVIQ?

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

Australia

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Norway

Philippines

Poland

Portugal

Saudi Arabia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

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 QUVIVIQ around the world.

Country	Patent Number	Title	Estimated Expiration
Malaysia	169986	BENZIMIDAZOLE-PROLINE DERIVATIVES
Singapore	10201702540U	BENZIMIDAZOLE-PROLINE DERIVATIVES
Eurasian Patent Organization	201600436	КРИСТАЛЛИЧЕСКАЯ СОЛЕВАЯ ФОРМА (S)-(2-(6-ХЛОР-7-МЕТИЛ-1H-БЕНЗО[D]ИМИДАЗОЛ-2-ИЛ)-2-МЕТИЛПИРРОЛИДИН-1-ИЛ)(5-МЕТОКСИ-2-(2H-1,2,3-ТРИАЗОЛ-2-ИЛ)ФЕНИЛ)МЕТАНОНА И ЕЕ ПРИМЕНЕНИЕ В КАЧЕСТВЕ АНТАГОНИСТОВ ОРЕКСИНОВОГО РЕЦЕПТОРА
Slovenia	2855453
Hungary	E034656

Supplementary Protection Certificates for QUVIVIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2855453	CA 2022 00041	Denmark		PRODUCT NAME: DARIDOREXANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SAERLIGT DARIDOREXANT HYDROCHLORID; REG. NO/DATE: EU/1/22/1638 20220502
2855453	301197	Netherlands		PRODUCT NAME: DARIDOREXANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER DARIDOREXANTHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1638 20220502
2855453	2022C/543	Belgium		PRODUCT NAME: DARIDOREXANT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE CHLORHYDRATE DE DARIDOREXANT; AUTHORISATION NUMBER AND DATE: EU/1/22/1638 20220502
2855453	2290037-7	Sweden		PRODUCT NAME: DARIDOREXANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR DARIDOREXANT HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1638/001-006 20220502
2855453	22C1047	France		PRODUCT NAME: DARIDOREXANT OU LE SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE CHLORHYDRATE DE DARIDOREXANT; REGISTRATION NO/DATE: EU/1/22/1638 20220502

QUVIVIQ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for QUVIVIQ

Introduction to QUVIVIQ

QUVIVIQ, also known as daridorexant, is a novel oral treatment for insomnia developed by Idorsia Pharmaceuticals US Inc. It was approved by the FDA in January 2022 and became available in US pharmacies in May 2022. QUVIVIQ is distinguished by its mechanism of action, targeting overactive wake signaling, a biological cause of insomnia[1].

Market Need and Potential

Insomnia affects a significant population, with approximately 25 million people in the US suffering from sleep disorders, yet only about 12 million are on prescribed medications. This gap presents a substantial market opportunity for QUVIVIQ. The overall US market for insomnia treatments is projected to reach $6.3 billion by 2030[1].

Launch and Early Adoption

Since its launch, QUVIVIQ has shown promising signs of adoption. By July 2022, the drug had dispensed over 1,100 prescriptions in a single week, with a steady increase in prescriptions and refills. QUVIVIQ quickly gained traction, becoming the leading branded insomnia medicine in new-to-brand prescriptions (NBRx) and total prescriptions (TRx) in the US commercial market within just 11 months of its launch[1][4].

Prescription Trends and Refills

Prescription trends for QUVIVIQ have been encouraging. By the third quarter of 2023, 48% of prescriptions were under the commercial model, up from 37% in the second quarter. This trend continued, with 57% of prescriptions written for commercial product by September 2023. The drug has also seen a significant number of refills, indicating patient satisfaction and adherence[3][4].

Competitive Landscape

QUVIVIQ operates in a competitive market alongside other insomnia treatments such as Belsomra and Dayvigo. In the week of July 15, 2022, QUVIVIQ notched 872 new-to-brand prescriptions, trailing Belsomra but ahead of Dayvigo. Despite this, QUVIVIQ's early performance suggests it could establish a strong foothold in the market[1].

Financial Performance

Revenue and Sales

As of the first nine months of 2024, QUVIVIQ generated net sales of CHF 39 million. This is part of Idorsia's total net revenue of CHF 53 million, which also includes sales to partners in the Asia-Pacific region and contract revenue from other collaborations[2].

Quarterly and Annual Projections

For 2024, Idorsia expects QUVIVIQ net sales to be around CHF 55 million. This is a modest but steady growth from the initial launch phase. The company forecasts a non-GAAP operating loss of around CHF 400 million for 2024, although this includes various one-off benefits and adjustments[2][5].

Cost Structure and Expenses

Idorsia has been managing its expenses closely, with SG&A expenses projected to be around CHF 265 million and R&D expenses around CHF 130 million for 2024. The company has also taken steps to control costs, including restructuring its convertible bond and benefiting from the Viatris deal[2][5].

Regional Expansion

United States

QUVIVIQ has been gaining traction in the US, with efforts to secure broader commercial coverage and Medicare reimbursement ongoing. The drug has been added to the CVS Caremark formulary, and work is in progress to get it covered by Medicare starting in 2024[3].

Europe and Other Markets

In Europe, QUVIVIQ was launched in Germany and Italy in November 2022, with positive feedback from physicians and patients. Launch preparations are underway in the UK, Spain, and France, and the drug has also been approved in Switzerland and Canada[4].

Challenges and Future Outlook

Despite the positive trends, Idorsia faces challenges such as securing immediate cash infusions to sustain operations. The company has predicted a dilutive stock sale to extend its cash runway into mid-2024. However, the overall outlook remains optimistic, with CEO Jean-Paul Clozel noting that even a modest market penetration of 15% to 20% could lead to blockbuster revenues[3].

Key Financial Metrics

• Net Sales: CHF 39 million in the first nine months of 2024[2].
• Projected Revenue: CHF 55 million for 2024[2][5].
• Operating Loss: Expected non-GAAP operating loss of around CHF 400 million for 2024[2][5].
• Expenses: SG&A expenses around CHF 265 million, R&D expenses around CHF 130 million for 2024[2].

Expert Insights

"Due to the large number of people suffering from insomnia, a new drug only has to have a market penetration of 15% to 20% to reach blockbuster revenues," said Idorsia CEO Jean-Paul Clozel. This highlights the significant potential for QUVIVIQ in the insomnia treatment market[1].

Illustrative Statistics

• Prescriptions: Over 22,000 prescriptions of QUVIVIQ dispensed in March 2023 alone[4].
• Market Share: QUVIVIQ became the leading branded insomnia medicine in new-to-brand prescriptions and total prescriptions in the US commercial market within 11 months[4].
• Revenue Projections: Forecasted revenue for QUVIVIQ in 2026 is $1.05 billion[1].

Conclusion

QUVIVIQ has made a promising start in the insomnia treatment market, with growing prescription numbers, increasing commercial coverage, and positive patient feedback. While Idorsia faces financial challenges, the drug's potential in a large and underserved market positions it for significant growth.

Key Takeaways

• QUVIVIQ targets overactive wake signaling, a unique mechanism in insomnia treatment.
• The drug has quickly become the leading branded insomnia medicine in the US commercial market.
• QUVIVIQ has shown steady growth in prescriptions and refills.
• Idorsia expects QUVIVIQ net sales to reach CHF 55 million in 2024.
• The company faces financial challenges but has a strong outlook for future growth.

Frequently Asked Questions

Q: What is QUVIVIQ and how does it work? A: QUVIVIQ (daridorexant) is an oral treatment for insomnia that targets overactive wake signaling, a biological cause of the condition.

Q: How has QUVIVIQ performed in the market since its launch? A: QUVIVIQ has shown promising adoption, becoming the leading branded insomnia medicine in new-to-brand prescriptions and total prescriptions in the US commercial market within 11 months of its launch.

Q: What are the financial projections for QUVIVIQ? A: Idorsia expects QUVIVIQ net sales to be around CHF 55 million for 2024, with forecasted revenue of $1.05 billion by 2026.

Q: What challenges is Idorsia facing with QUVIVIQ? A: Idorsia is facing financial challenges, including the need for immediate cash infusions and managing operating expenses, but the overall outlook for QUVIVIQ remains positive.

Q: How is QUVIVIQ expanding globally? A: QUVIVIQ has been launched in several European countries, including Germany, Italy, and Switzerland, with plans for further expansion in the UK, Spain, and France.

Cited Sources

1. Pharmaceutical Executive: "A Sleeping Giant?: Quviviq"
2. Biospace: "Idorsia announces financial results for the first nine months of 2024"
3. Citeline: "Idorsia Cost-Reduction Effort Will End in 2023"
4. Idorsia: "Idorsia announces financial results for the first quarter 2023"
5. GlobeNewswire: "Idorsia announces financial results for the first half 2024"