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LITFULO Drug Patent Profile

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

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

This drug has eighty-five patent family members in forty-seven countries.

The generic ingredient in LITFULO is ritlecitinib tosylate. Two suppliers are listed for this compound. Additional details are available on the ritlecitinib tosylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Litfulo

Litfulo will be eligible for patent challenges on June 23, 2027. 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 June 23, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LITFULO

International Patents:	85
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Drug Prices:	Drug price information for LITFULO
What excipients (inactive ingredients) are in LITFULO?	LITFULO excipients list
DailyMed Link:	LITFULO at DailyMed

See drug prices for LITFULO

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

215830

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 LITFULO

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

US Patents and Regulatory Information for LITFULO

LITFULO is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
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
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

International Patents for LITFULO

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

Country	Patent Number	Title	Estimated Expiration
Australia	2019363840	Pyrrolo(2,3-d)pyrimidine tosylate salt, crystalline form thereof and manufacturing process and intermediates thereto
Chile	2016001216	Acrilamidas de pirrolo[2,3-d]pirimidinilo, pirrolo[2,3-b]pirazinilo y pirrolo[2,3-d]piridinilo.
Taiwan	I548636
World Intellectual Property Organization (WIPO)	2015083028
Denmark	3318565
Poland	3318565
New Zealand	720092	Pyrrolo[2,3-d]pyrimidinyl, pyrrolo[2,3-b]pyrazinyl and pyrrolo[2,3-d]pyridinyl acrylamides

Supplementary Protection Certificates for LITFULO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3077395	PA2023537	Lithuania		PRODUCT NAME: RITLECITINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1755 20230915
3077395	40/2023	Austria		PRODUCT NAME: RITLECITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/23/1755 (MITTEILUNG) 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
3077395	LUC00322	Luxembourg		PRODUCT NAME: RITLECITINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1755 20230918
3077395	122023000064	Germany		PRODUCT NAME: RITLECITINIB ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1755 20230915

LITFULO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LITFULO (Ritlecitinib)

Introduction to LITFULO

LITFULO (ritlecitinib) is a groundbreaking oral treatment approved by the FDA for the management of severe alopecia areata in individuals aged 12 and older. This kinase inhibitor, developed by Pfizer, targets Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases, making it a significant advancement in the treatment of this autoimmune disease[2][5].

Market Need and Competition

Alopecia areata, characterized by substantial hair loss, had limited FDA-approved treatment options until the approval of LITFULO. The market was previously dominated by off-label drug therapies, creating a substantial unmet need for effective treatments[3].

LITFULO enters a market where Eli Lilly and Incyte's Olumiant, another JAK inhibitor, has already established itself. However, LITFULO is the first JAK3/TEC inhibitor approved for dermatological use, offering a distinct mechanism of action that could differentiate it from existing treatments[4].

Clinical Efficacy and Approval

The FDA approval of LITFULO was based on the results of the ALLEGRO Phase 2b/3 trial, which enrolled 718 patients with severe alopecia areata. The trial demonstrated that 23% of patients treated with LITFULO 50 mg achieved 80% or more scalp hair coverage after six months, compared to 1.6% of patients on placebo. This significant efficacy was consistent across both adolescents and adults[2].

Market Reception and Adoption

Despite being the second JAK inhibitor to market, LITFULO faces a competitive landscape. Pre-launch metrics indicated lower familiarity among dermatologists compared to Olumiant, which had been on the market for rheumatoid arthritis for several years. However, dermatologists have shown a willingness to adopt JAK inhibitors based on their experience with Olumiant and other similar drugs[4].

Commercial Potential

Pfizer anticipates significant commercial success for LITFULO. The drug is projected to generate over $1 billion in sales for the treatment of alopecia areata alone. Additionally, LITFULO is being evaluated for other indications such as vitiligo, rheumatoid arthritis, ulcerative colitis, and Crohn’s disease, further expanding its potential market[3].

Regulatory and Global Expansion

Regulatory applications for LITFULO have been submitted to several countries, including China, the European Union, Japan, and the United Kingdom. The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for ritlecitinib, with a decision expected in the third quarter of 2023. This global expansion strategy is crucial for maximizing the drug's market reach and revenue potential[2].

Safety and Risk Considerations

Like other JAK inhibitors, LITFULO carries safety warnings, including risks associated with increased susceptibility to infections and potential cardiovascular and thromboembolic events. These risks are being closely monitored, and regulatory authorities will continue to assess the benefit-risk profile of the drug[2][4].

Patient Outcomes and Satisfaction

Clinical trials have shown that LITFULO can achieve significant hair regrowth in a short period. In the ALLEGRO trial, 23% of patients on LITFULO saw 80% or more scalp hair coverage in just under six months, with some patients achieving this level of regrowth in over four months. This rapid and significant improvement in hair regrowth is expected to enhance patient satisfaction and adherence to treatment[5].

Financial Projections and Revenue Growth

Given its strong clinical efficacy and the large unmet need in the alopecia areata market, LITFULO is poised for substantial revenue growth. Pfizer's identification of LITFULO as one of its potential blockbusters by 2025 underscores the company's confidence in the drug's commercial success. The drug's performance will be closely watched, especially as it competes with Olumiant and other emerging treatments in the alopecia areata market[3][4].

Key Takeaways

• First FDA-Approved Treatment for Adolescents: LITFULO is the first and only FDA-approved treatment for severe alopecia areata in adolescents as young as 12.
• Clinical Efficacy: Demonstrated significant hair regrowth in clinical trials, with 23% of patients achieving 80% or more scalp hair coverage.
• Market Competition: Enters a market with existing JAK inhibitors like Olumiant but offers a distinct mechanism of action.
• Global Expansion: Regulatory applications submitted to multiple countries, with a decision from the EMA expected soon.
• Commercial Potential: Projected to generate over $1 billion in sales for alopecia areata treatment alone.
• Safety Considerations: Carries safety warnings common to JAK inhibitors, which are being closely monitored.

FAQs

Q: What is LITFULO, and how does it work? A: LITFULO (ritlecitinib) is an oral treatment for severe alopecia areata that works by inhibiting Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases.

Q: Who is eligible for LITFULO treatment? A: LITFULO is approved for individuals aged 12 and older with severe alopecia areata.

Q: What were the key findings from the clinical trials of LITFULO? A: Clinical trials showed that 23% of patients treated with LITFULO achieved 80% or more scalp hair coverage after six months, compared to 1.6% of patients on placebo.

Q: How does LITFULO compare to other treatments like Olumiant? A: LITFULO is the first JAK3/TEC inhibitor approved for dermatological use, offering a distinct mechanism of action compared to Olumiant.

Q: What are the potential side effects of LITFULO? A: LITFULO carries safety warnings similar to other JAK inhibitors, including increased susceptibility to infections and potential cardiovascular and thromboembolic events.

Sources

1. Pfizer Receives FDA Approval on Alopecia Areata Treatment Litfulo - Pharm Exec.
2. FDA Approves Pfizer's LITFULO™ (Ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata - BioSpace.
3. Advancements in the Alopecia Areata Treatment Paradigm - DelveInsight.
4. Pfizer's Litfulo Poised to Follow Similar Trajectory as Eli Lilly/Incyte's Olumiant for the Treatment of Severe Alopecia Areata - BioSpace.
5. Home Page | LITFULO™ (ritlecitinib) | Safety Info - LITFULO.