RYKINDO Drug Patent Profile

Which patents cover Rykindo, and what generic alternatives are available?

Rykindo is a drug marketed by Shandong Luye and is included in one NDA. There are five patents protecting this drug.

This drug has thirty-six patent family members in fourteen countries.

The generic ingredient in RYKINDO is risperidone. There are thirty drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the risperidone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rykindo

A generic version of RYKINDO was approved as risperidone by APOTEX INC on September 15^th, 2008.

Summary for RYKINDO

International Patents:	36
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	143
Patent Applications:	4,025
What excipients (inactive ingredients) are in RYKINDO?	RYKINDO excipients list
DailyMed Link:	RYKINDO at DailyMed

US Patents and Regulatory Information for RYKINDO

RYKINDO is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shandong Luye	RYKINDO	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212849-001	Jan 13, 2023		RX	Yes	No	10,406,161		Y
Shandong Luye	RYKINDO	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212849-004	Jan 13, 2023		RX	Yes	No	9,532,991		Y
Shandong Luye	RYKINDO	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212849-002	Jan 13, 2023		RX	Yes	Yes	10,098,882		Y
Shandong Luye	RYKINDO	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212849-001	Jan 13, 2023		RX	Yes	No	9,446,135		Y

EU/EMA Drug Approvals for RYKINDO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Laboratorios Farmacéuticos Rovi, S.A.	Okedi	risperidone	EMEA/H/C/005406 Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.	Authorised	no	no	no	2022-02-14

International Patents for RYKINDO

See the table below for patents covering RYKINDO around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3199146	COMPOSITION DE MICROSPHÈRES À LIBÉRATION PROLONGÉE DE RISPÉRIDONE (RISPERIDONE SUSTAINED RELEASE MICROSPHERE COMPOSITION)
Spain	2607497
Portugal	2701687
Hungary	E032310

Supplementary Protection Certificates for RYKINDO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0196132	94C0008	Belgium		PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208

RYKINDO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rykindo®

Introduction to Rykindo®

Rykindo®, developed by Luye Pharma Group, is a groundbreaking extended-release microsphere formulation of risperidone, designed for the treatment of schizophrenia and bipolar I disorder. This innovative drug has marked several significant milestones, both in terms of regulatory approvals and market impact.

Regulatory Approvals and Market Entry

U.S. FDA Approval

Rykindo® made history by becoming the first Chinese innovative drug to receive U.S. FDA approval for marketing in the United States. This approval, granted in January 2023, was a pivotal moment for Luye Pharma, signifying its entry into the global pharmaceutical market with a homegrown innovation[4][5].

China and Other Markets

In addition to the U.S., Rykindo® was approved for market launch in China in 2021 under the trade name 瑞欣妥®. The drug is also undergoing registration processes in Europe and other emerging countries, with plans for a broader global launch[1][4].

Market Impact and Competitive Advantage

Medication Compliance

Rykindo® addresses a critical issue in the treatment of schizophrenia and bipolar disorder: medication compliance. By requiring only a bi-weekly intramuscular injection, it simplifies the treatment regimen compared to oral antipsychotic drugs. This formulation ensures a steady plasma drug level, which is achieved faster than with the reference drug[1][4].

Therapeutic Area Focus

Luye Pharma has a robust product portfolio in the central nervous system (CNS) therapeutic area, which includes schizophrenia, bipolar disorder, depression, Parkinson’s disease, and Alzheimer’s disease. Rykindo® is a key component of this portfolio, contributing to the company's strategic goal of becoming a global leader in the CNS therapeutic area[2][4].

Financial Performance and Growth

Revenue Growth

The approval and launch of Rykindo® have significantly contributed to Luye Pharma's revenue growth. In 2022, the company reported a 15.0% year-on-year increase in revenue to RMB 5.982 billion, with normalized EBITDA growing by 44.8% and normalized net profit attributable to shareholders increasing by 101.8%[2].

Diversification of Revenue Sources

The launch of Rykindo® and other new products has diversified Luye Pharma's revenue sources, reducing dependence on individual products. This strategic synergy between existing and new products ensures high-quality growth across key therapeutic areas such as oncology and CNS[2].

Global Expansion

Luye Pharma's "innovation + internationalization" strategy has driven its global expansion. The approval of Rykindo® in the U.S. marked the beginning of the company's efforts to launch in-house developed drugs globally. This strategy is expected to add further momentum to the company's global business growth over the next three years[2].

Pipeline and Future Developments

Other Innovative Products

In addition to Rykindo®, Luye Pharma has several other pipeline projects, including Rotigotine extended-release microspheres, Anshufacine Hydrochloride extended-release tablets, Paliperidone Palmitate injectable suspension, and Rivastigmine multi-day transdermal patch. These products are expected to further enhance the company's global presence and contribute to its growth trajectory[1][2].

Market Potential

The global market for CNS drugs is significant, with 40 million sufferers of bipolar disorder and 24 million schizophrenia patients worldwide as of 2019. The approval and launch of Rykindo® in multiple markets position Luye Pharma to capture a substantial share of this market, driving future revenue and profit growth[4].

Strategic Synergy and Global Capabilities

Complete Global Development System

Luye Pharma has established a complete "global development + global manufacturing + global marketing" system, which is crucial for the successful launch of new drugs globally. This system, combined with strong commercial capabilities in international markets, will drive the company's high-quality growth in the coming years[2].

Robust R&D Platforms

The company's focus on three major R&D platforms—Novel Drug Delivery Systems (NDDS), New Molecular Entity (NME), and Antibodies—has led to breakthroughs in key technologies. This robust R&D capability ensures a continuous pipeline of innovative products, supporting long-term growth[2].

Key Takeaways

• Regulatory Milestones: Rykindo® is the first Chinese innovative drug to receive U.S. FDA approval, marking a significant step in Luye Pharma's globalization.
• Market Impact: The drug improves medication compliance and offers a competitive advantage in the CNS therapeutic area.
• Financial Growth: The launch of Rykindo® has contributed to Luye Pharma's revenue and profit growth, diversifying its revenue sources.
• Global Expansion: Luye Pharma's "innovation + internationalization" strategy is driving its global expansion, with multiple new drugs expected to be launched globally.
• Pipeline and Future Developments: The company has a robust pipeline of innovative products, ensuring continued growth and market presence.

FAQs

Q: What is Rykindo® and how is it administered?

A: Rykindo® is an extended-release microsphere formulation of risperidone, administered via intramuscular injection once every two weeks for the treatment of schizophrenia and bipolar I disorder[4].

Q: What was the significance of Rykindo®'s FDA approval?

A: Rykindo® became the first Chinese innovative drug to receive U.S. FDA approval, marking a significant milestone in Luye Pharma's globalization efforts[1][4].

Q: How does Rykindo® improve medication compliance?

A: Rykindo® simplifies the treatment regimen by requiring only a bi-weekly injection, ensuring a steady plasma drug level and improving medication compliance compared to oral antipsychotic drugs[1][4].

Q: What is Luye Pharma's strategy for global growth?

A: Luye Pharma follows a dual strategy of "innovation + internationalization," focusing on developing new drugs and expanding globally through a complete "global development + global manufacturing + global marketing" system[2].

Q: What other innovative products is Luye Pharma developing?

A: Luye Pharma has several pipeline projects, including Rotigotine extended-release microspheres, Anshufacine Hydrochloride extended-release tablets, and Rivastigmine multi-day transdermal patch, among others[1][2].

Sources

1. Luye Pharma's Rykindo® Expected to Be the First Chinese Innovative Drug to Receive U.S. FDA Approval. Biospace, March 28, 2019.
2. Luye Pharma Announces 2022 Financial Results. Luye Pharma, March 30, 2023.
3. Generic RISPERIDONE INN entry. Drug Patent Watch.
4. FDA Approves Luye Pharma's Rykindo® for the Treatment of Schizophrenia and Bipolar 1 Disorder. Biospace, January 15, 2023.
5. FDA Approves Risperidone for Schizophrenia, Bipolar I Disorder. Pharmacy Times, January 16, 2023.