RITLECITINIB TOSYLATE - Generic Drug Details

What are the generic drug sources for ritlecitinib tosylate and what is the scope of patent protection?

Ritlecitinib tosylate is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ritlecitinib tosylate has eighty-five patent family members in forty-seven countries.

Two suppliers are listed for this compound.

Summary for RITLECITINIB TOSYLATE

International Patents:	85
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	2
DailyMed Link:	RITLECITINIB TOSYLATE at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

CAPSULE;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.

Pharmacology for RITLECITINIB TOSYLATE

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 1A2 Inhibitors Cytochrome P450 3A Inhibitors Janus Kinase 3 Inhibitors Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for RITLECITINIB TOSYLATE

L04AF	Janus-associated kinase (JAK) inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for RITLECITINIB TOSYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	LITFULO	ritlecitinib tosylate	CAPSULE;ORAL	215830-001	Jun 23, 2023		RX	Yes	Yes				Y
Pfizer	LITFULO	ritlecitinib tosylate	CAPSULE;ORAL	215830-001	Jun 23, 2023		RX	Yes	Yes			Y	Y
Pfizer	LITFULO	ritlecitinib tosylate	CAPSULE;ORAL	215830-001	Jun 23, 2023		RX	Yes	Yes
Pfizer	LITFULO	ritlecitinib tosylate	CAPSULE;ORAL	215830-001	Jun 23, 2023		RX	Yes	Yes

International Patents for RITLECITINIB TOSYLATE

Country	Patent Number	Title	Estimated Expiration
South Korea	20210080468	피롤로[2,3-d]피리미딘 토실레이트 염, 이의 결정질 형태, 이의 제조 방법 및 이에 대한 중간체
Guatemala	201600098	ACRILAMIDAS DE PIRROLO [2,3-D] PIRIMIDINILO, PIRROLO [2,3-B] PIRAZINILO Y PIRROLO [2,3-D] PIRIDINILO
Malaysia	187446	PYRROLO[2,3-D]PYRIMIDINYL, PYRROLO[2,3-B]PYRAZINYL AND PYRROLO[2,3-D]PYRIDINYL ACRYLAMIDES
Taiwan	202033525	Pyrrolo [ 2,3-D] pyrimidine tosylate salt, crystalline form thereof and manufacturing process and intermediates thereto
Japan	6192839
Portugal	3318565

Supplementary Protection Certificates for RITLECITINIB TOSYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3077395	122023000064	Germany		PRODUCT NAME: RITLECITINIB ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1755 20230915
3077395	CA 2023 00028	Denmark		PRODUCT NAME: RITLECITINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1755 20230915
3077395	LUC00322	Luxembourg		PRODUCT NAME: RITLECITINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1755 20230918
3077395	301245	Netherlands		PRODUCT NAME: RITLECITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/23/1755 20230918
3077395	2023C/544	Belgium		PRODUCT NAME: RITLECITINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1755 20230918
3077395	CR 2023 00028	Denmark		PRODUCT NAME: RITLECITINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1755 20230915

RITLECITINIB TOSYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ritlecitinib Tosylate

Introduction

Ritlecitinib tosylate, developed by Pfizer Inc., is a groundbreaking drug that has recently gained approval for the treatment of severe alopecia areata in adults and adolescents aged 12 years and older. This article delves into the market dynamics and financial trajectory of this innovative medication.

Regulatory Approvals and Milestones

Ritlecitinib tosylate has achieved significant regulatory milestones. It was approved by the U.S. Food and Drug Administration (FDA) in June 2023 and by the European Medicines Agency (EMA) in September 2023. Additionally, regulatory submissions have been completed in the United Kingdom, China, and Japan, with approvals anticipated in these regions[2][5].

Market Need and Target Population

Alopecia areata is a common autoimmune disease characterized by sudden hair loss, affecting not only the scalp but also other parts of the body. This condition imposes significant psychological and social burdens on patients. Ritlecitinib tosylate addresses a critical need for an effective treatment, particularly for adolescents and adults who have failed or are intolerant to traditional treatments[4].

Mechanism of Action and Efficacy

Ritlecitinib tosylate is a highly selective inhibitor of Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) kinase family. It works by inhibiting the immune system's attack on hair follicles, promoting hair regeneration. Clinical studies have shown that approximately 23.0% of patients can achieve 80% or more scalp hair regeneration after 24 weeks of treatment, significantly outperforming traditional methods[4][5].

Clinical Trials and Safety Profile

The drug's efficacy and safety were established through several clinical trials, including the pivotal ALLEGRO Phase 2b/3 study and the ongoing ALLEGRO-LT Phase 3 open-label, long-term study. These studies demonstrated that ritlecitinib was well tolerated, with common adverse events including headache, nasopharyngitis, and upper respiratory tract infections. Serious adverse events were rare, and no cardiac events, deaths, or opportunistic infections were reported through Week 48[2].

Market Potential and Competitive Landscape

Ritlecitinib tosylate is the first and only approved drug in its class for the treatment of severe alopecia areata in adolescents and adults. This unique positioning gives it a significant market advantage. The drug fills a gap in the treatment landscape, offering a new and effective option for patients who have limited or no response to existing therapies[4].

Financial Projections and Revenue Potential

Given its innovative status and the unmet need it addresses, ritlecitinib tosylate is expected to generate substantial revenue. The approval in major markets such as the U.S. and Europe, along with anticipated approvals in other regions, sets the stage for a robust financial trajectory. Pfizer's investment in the drug's development and the positive clinical trial outcomes suggest a high potential for market domination in the alopecia areata treatment space.

Pricing and Access

The pricing strategy for ritlecitinib tosylate will be crucial in determining its market penetration. While specific pricing details are not yet publicly available, the drug's unique efficacy and safety profile are likely to support a premium pricing strategy. Access programs and patient assistance initiatives may also be implemented to ensure that the drug is accessible to a broader patient population.

Risk Management and Safety Monitoring

As with any new drug, there are risks associated with the use of ritlecitinib tosylate. Pfizer and regulatory authorities will continue to monitor the drug's safety profile through post-marketing surveillance. The risk management plan includes regular physical examinations and monitoring for potential side effects, ensuring the safe use of the drug in the long term[4].

Global Expansion and Regulatory Submissions

In addition to the approvals in the U.S. and Europe, ritlecitinib tosylate has been approved in China under the brand name LITFULO®. Regulatory submissions in other countries are ongoing, indicating a global expansion strategy. This widespread regulatory acceptance is expected to drive the drug's financial performance across various markets[2][4].

Population Pharmacokinetic Models

The development of ritlecitinib tosylate has been supported by comprehensive population pharmacokinetic models. These models, updated iteratively with accumulating data, have helped in understanding the drug's systemic exposures and informing the approved product label. This rigorous approach ensures that the drug is used optimally and safely across different patient populations[3].

Patient Impact and Quality of Life

The approval of ritlecitinib tosylate brings new hope to patients with severe hair loss. By promoting hair regeneration and reducing the psychological and social burdens associated with alopecia areata, the drug significantly improves patients' quality of life. This improvement in patient outcomes is a key driver of the drug's market success and financial trajectory.

Conclusion

Ritlecitinib tosylate is poised to make a significant impact in the treatment of alopecia areata, driven by its unique mechanism of action, strong clinical efficacy, and favorable safety profile. With regulatory approvals in major markets and ongoing global expansion, the financial trajectory of this drug is expected to be robust. As the first and only approved drug in its class, ritlecitinib tosylate is set to dominate the market for severe alopecia areata treatment.

Key Takeaways

• Regulatory Approvals: Approved by FDA and EMA, with submissions in other regions.
• Market Need: Addresses a critical need for effective treatment of severe alopecia areata.
• Efficacy: Demonstrated significant hair regeneration in clinical trials.
• Safety Profile: Well tolerated with common adverse events managed effectively.
• Market Potential: Unique positioning as the first and only approved drug in its class.
• Financial Projections: Expected to generate substantial revenue due to its innovative status and market demand.
• Global Expansion: Approved in China and undergoing regulatory submissions globally.
• Patient Impact: Significantly improves patients' quality of life by promoting hair regeneration.

FAQs

Q: What is the primary indication for ritlecitinib tosylate? A: Ritlecitinib tosylate is primarily indicated for the treatment of severe alopecia areata in adults and adolescents aged 12 years and older.

Q: How does ritlecitinib tosylate work? A: Ritlecitinib tosylate works by inhibiting the Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) kinase family, thereby reducing the immune system's attack on hair follicles.

Q: What are the common adverse events associated with ritlecitinib tosylate? A: Common adverse events include headache, nasopharyngitis, and upper respiratory tract infections.

Q: Has ritlecitinib tosylate been approved globally? A: While it has been approved in the U.S., Europe, and China, regulatory submissions are ongoing in other regions.

Q: How does ritlecitinib tosylate impact patients' quality of life? A: By promoting hair regeneration, ritlecitinib tosylate significantly improves patients' quality of life, reducing the psychological and social burdens associated with alopecia areata.

Sources

1. Synapse: Ritlecitinib Tosilate - Drug Targets, Indications, Patents.
2. Pfizer: FDA and EMA Accept Regulatory Submission for Pfizer's Ritlecitinib.
3. PubMed: Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Development.
4. IMC Clinics: [LITFULO®] New Innovative Alopecia Areata Drug.
5. DrugBank: Ritlecitinib tosylate.