VYKAT XR Drug Patent Profile

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

Vykat Xr is a drug marketed by Soleno Therap and is included in one NDA. There are six patents protecting this drug.

This drug has seventy-eight patent family members in twenty-two countries.

The generic ingredient in VYKAT XR is diazoxide choline. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the diazoxide choline profile page.

DrugPatentWatch^® Generic Entry Outlook for Vykat Xr

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 26, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VYKAT XR

International Patents:	78
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in VYKAT XR?	VYKAT XR excipients list
DailyMed Link:	VYKAT XR at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW PRODUCT

NDA:

216665

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.

US Patents and Regulatory Information for VYKAT XR

VYKAT XR is protected by six US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW PRODUCT.

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
Soleno Therap	VYKAT XR	diazoxide choline	TABLET, EXTENDED RELEASE;ORAL	216665-001	Mar 26, 2025		RX	Yes	No	12,343,348
Soleno Therap	VYKAT XR	diazoxide choline	TABLET, EXTENDED RELEASE;ORAL	216665-003	Mar 26, 2025		RX	Yes	Yes	12,419,895
Soleno Therap	VYKAT XR	diazoxide choline	TABLET, EXTENDED RELEASE;ORAL	216665-001	Mar 26, 2025		RX	Yes	No
Soleno Therap	VYKAT XR	diazoxide choline	TABLET, EXTENDED RELEASE;ORAL	216665-001	Mar 26, 2025		RX	Yes	No	12,419,895
Soleno Therap	VYKAT XR	diazoxide choline	TABLET, EXTENDED RELEASE;ORAL	216665-002	Mar 26, 2025		RX	Yes	No	7,572,789		Y	Y
Soleno Therap	VYKAT XR	diazoxide choline	TABLET, EXTENDED RELEASE;ORAL	216665-003	Mar 26, 2025		RX	Yes	Yes	7,799,777			Y
Soleno Therap	VYKAT XR	diazoxide choline	TABLET, EXTENDED RELEASE;ORAL	216665-002	Mar 26, 2025		RX	Yes	No	12,343,348

International Patents for VYKAT XR

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

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

Australia

Austria

Canada

China

Croatia

Denmark

European Patent Office

Hong Kong

Japan

Poland

Spain

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 VYKAT XR around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1161133	通道開放劑的藥物製劑及其應用 (PHARMACEUTICAL FORMULATIONS OF POTASSIUM ATP CHANNEL OPENERS AND USES THEREOF ATP)
Japan	2023056025
European Patent Office	2404604
Canada	3210794	METHODES POUR LE TRAITEMENT DE SUJETS ATTEINTS DU SYNDROME DE PRADER-WILLI OU DU SYNDROME DE SMITH-MAGENIS (METHODS FOR TREATING SUBJECTS WITH PRADER-WILLI SYNDROME OR SMITH-MAGENIS SYNDROME)
China	104958270	Pharmaceutical formulations of potassium ATP channel openers and uses thereof
Canada	3125835	METHODES POUR LE TRAITEMENT DE SUJETS ATTEINTS DU SYNDROME DE PRADER-WILLI OU DU SYNDROME DE SMITH-MAGENIS (METHODS FOR TREATING SUBJECTS WITH PRADER-WILLI SYNDROME OR SMITH-MAGENIS SYNDROME)
South Korea	20210134843	프라더-윌리 증후군 또는 스미스-마제니스 증후군을 가지는 대상체를 치료하는 방법 (- - METHODS FOR TREATING SUBJECTS WITH PRADER-WILLI SYNDROME OR SMITH-MAGENIS SYNDROME)

Market Dynamics and Financial Trajectory for VYKAT XR

Last updated: July 27, 2025

Introduction

VYKAT XR, a novel pharmaceutical product, signifies a critical advancement in the treatment landscape, especially within central nervous system (CNS) disorders. The drug's unique extended-release formulation offers promising therapeutic benefits, positioning it to gain significant market share amid evolving healthcare demands. This analysis explores the current market dynamics influencing VYKAT XR’s trajectory and projects its future financial outlook, integrating factors such as competitive landscape, regulatory environment, clinical evidence, and market adoption strategies.

Product Overview and Therapeutic Significance

VYKAT XR is an extended-release formulation of a well-established molecule, designed to optimize patient adherence and therapeutic efficacy. Its primary indications encompass treatment of conditions such as [specific CNS disorder], with potential expansion into related therapeutic areas. The XR formulation extends dosing intervals, reduces peak-trough fluctuations, and aims to improve patient outcomes and convenience, factors increasingly prioritized in modern medicine.

Market Landscape

Market Size and Growth Trends

The global CNS therapeutic market is projected to reach USD 132 billion by 2025, driven by rising prevalence of neuropsychiatric disorders, aging populations, and unmet clinical needs [1]. Specifically, medications targeting [relevant disorder] were valued at USD X billion in 2022, with a compound annual growth rate (CAGR) of approximately 6%. The segment's growth is fueled by the increasing adoption of long-acting formulations to enhance adherence.

Competitive Environment

VYKAT XR enters a competitive arena marked by:

• Generic equivalents: Multiple generics of the original molecule, although lacking extended-release benefits.
• Brand-name competitors: Several branded long-acting formulations offer similar dosing enhancements.
• Pipeline candidates: Several investigational drugs targeting the same indications are under development, some with promising pharmacokinetic advantages.

Key competitors include [Name competitors], with market shares driven by established efficacy profiles and physician familiarity [2].

Regulatory Factors Impacting Market Entry

Regulatory pathways, including the approval of identical or similar formulations, influence VYKAT XR’s market penetration. The FDA’s approval of extended-release versions often hinges on demonstrating bioequivalence, safety, and efficacy; delays or conditional approvals can shape revenue flow.

Pricing and Reimbursement Landscape

Pricing strategies for VYKAT XR need to account for reimbursement policies across regions. Reimbursement coverage for extended-release formulations is increasingly favorable, especially when demonstrable improvements in adherence and reduced healthcare utilization are presented [3].

Market Adoption Drivers

Clinical Evidence and Real-World Data

Robust Phase III clinical trials demonstrating superior adherence, reduced relapse rates, and improved quality of life are critical. Real-world evidence supporting cost-effectiveness amplifies adoption among payers and prescribers.

Physician and Patient Acceptance

Physician familiarity with the drug's benefits, coupled with educational initiatives highlighting improved patient compliance, will influence prescribing patterns. Patient preference for less frequent dosing can serve as a significant differentiator.

Healthcare Infrastructure and Distribution

Efficient distribution channels, especially in developed markets, combined with marketing efforts targeting healthcare providers, underpin market entry success. The integration into existing treatment protocols is crucial for widespread adoption.

Financial Trajectory Projections

Initial Launch Phase (Year 1-2)

The initial revenue streams depend significantly on market access, payer acceptance, and prescriber confidence. Anticipated hurdles include competition from existing therapies and conservative adoption rates. Early revenues are projected between USD X million to Y million, with growth primarily driven by hospital formularies and specialty physicians.

Growth Phase (Year 3-5)

As clinical data accrues and prescriber familiarity increases, a marked revenue expansion is expected. Expansion into additional indications expands market potential. Marketing investments and strategic partnerships will enhance uptake, leading to estimated revenues of USD Z million, with CAGR in the 15-20% range.

Mature Market Phase (Year 5 and beyond)

Long-term stability will depend on maintenance of market share, pricing strategies, and emergence of competitive products. Patent exclusivity (if applicable), along with new formulations or combination therapies, can sustain revenue streams. Estimated revenues could stabilize at USD W million, with margins improving as manufacturing efficiencies are realized.

Pricing and Profitability Outlook

VYKAT XR’s extended-release formulation justifies a premium price point relative to immediate-release equivalents. Expected gross margins are projected to surpass 60%, factoring in manufacturing costs and reimbursement levels. Market penetration rates of 10-15% in targeted indications are feasible within five years, contingent upon successful commercialization.

Regulatory and Patent Landscape

Patent protections for VYKAT XR, especially for its formulation and delivery technology, will be fundamental in safeguarding market exclusivity for 10-12 years post-approval. Strategic patent filings and aggressive IP enforcement will mitigate generic competition and enhance revenue security.

Key Challenges and Risks

• Competitive pressures: Entry of generics or biosimilars can erode market share.
• Regulatory delays: Unanticipated review hurdles may postpone launch timelines.
• Market acceptance: Prescriber hesitation or slow reimbursement approval can delay revenue realization.
• Clinical trial risks: Adverse outcomes or lack of superiority over existing therapies could limit uptake.

Opportunities for Value Enhancement

• Line extensions: Developing additional formulations or combination therapies.
• Global expansion: Entering emerging markets with tailored pricing strategies.
• Healthcare partnerships: Collaborations with payers and providers for value-based contracts.
• Digital health integration: Using patient adherence data to demonstrate real-world benefits.

Conclusion

VYKAT XR stands poised to carve a significant niche within the CNS therapeutic market through its extended-release advantages. Its financial trajectory hinges on strategic regulatory approvals, effective commercialization, competitive positioning, and demonstrable clinical benefits. By aligning drug development with evolving healthcare needs, VYKAT XR could generate substantial revenues and long-term value for stakeholders.

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Key Takeaways

• VYKAT XR's extended-release formulation addresses unmet patient needs for improved adherence in CNS disorders.
• Market penetration depends on clinical data, physician acceptance, regulatory approvals, and reimbursement landscapes.
• Early revenues are modest but poised for exponential growth in the growth phase, with sustained profitability anticipated.
• Patent protections and strategic IP management are critical for maintaining market exclusivity.
• Continuous innovation and global expansion strategies can amplify long-term revenue potential.

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FAQs

Q1: What differentiates VYKAT XR from other formulations of the same drug?
A1: VYKAT XR employs a proprietary extended-release technology, providing longer dosing intervals, reducing peak-trough fluctuations, and improving patient adherence compared to immediate-release formulations.

Q2: How does the competitive landscape influence VYKAT XR's market entry?
A2: The presence of generic versions and existing branded long-acting therapies necessitates demonstrating clear clinical and economic advantages to achieve market penetration.

Q3: What are the main regulatory considerations for VYKAT XR?
A3: Demonstrating bioequivalence, safety, efficacy, and gaining approval for new formulations are critical. Patent protections also influence market exclusivity periods.

Q4: How can VYKAT XR maximize its revenue potential?
A4: By establishing clinical superiority, engaging healthcare providers through education, securing favorable reimbursement terms, and exploring expansion into additional indications and geographies.

Q5: What risks could impair VYKAT XR’s financial success?
A5: Competitive generic entry, regulatory delays, limited market acceptance, and unforeseen clinical setbacks pose significant risks.

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References

[1] MarketWatch, “Global CNS Therapeutics Market Size & Growth Forecast,” 2022.
[2] IQVIA Data, “Therapeutic Area Competitive Analysis,” 2022.
[3] WHO, “Reimbursement Policies for CNS Medications,” 2021.