Ruxolitinib phosphate - Generic Drug Details

What are the generic sources for ruxolitinib phosphate and what is the scope of freedom to operate?

Ruxolitinib phosphate is the generic ingredient in two branded drugs marketed by Incyte Corp and is included in two NDAs. There are twenty patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ruxolitinib phosphate has three hundred and thirty-five patent family members in forty-nine countries.

There are two drug master file entries for ruxolitinib phosphate. One supplier is listed for this compound.

Summary for ruxolitinib phosphate

International Patents:	335
US Patents:	20
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	27
Patent Applications:	916
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ruxolitinib phosphate
DailyMed Link:	ruxolitinib phosphate at DailyMed

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

Constraining patent/regulatory exclusivity:

8,722,693*PED

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

8,722,693*PED

Dosage:

CREAM;TOPICAL

^*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 ruxolitinib phosphate

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

Sponsor	Phase
City of Hope Medical Center	Phase 2
Zhengzhou University	Phase 4
Philipps University Marburg Medical Center	Phase 2

See all ruxolitinib phosphate clinical trials

Pharmacology for ruxolitinib phosphate

Drug Class	Janus Kinase Inhibitor Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ruxolitinib phosphate

D11AH	Agents for dermatitis, excluding corticosteroids
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

L01EJ	Janus-associated kinase (JAK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for RUXOLITINIB PHOSPHATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OPZELURA	Cream	ruxolitinib phosphate	1.5%	215309	1	2023-07-31
JAKAFI	Tablets	ruxolitinib phosphate	5 mg, 10 mg, 15 mg, 20 mg, and 25 mg	202192	1	2015-12-17

US Patents and Regulatory Information for ruxolitinib phosphate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-001	Nov 16, 2011		RX	Yes	No	10,016,429*PED				Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-002	Nov 16, 2011		RX	Yes	No	8,822,481*PED				Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-004	Nov 16, 2011		RX	Yes	No	9,079,912*PED				Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-005	Nov 16, 2011		RX	Yes	Yes	8,829,013*PED				Y

International Patents for ruxolitinib phosphate

Country	Patent Number	Title	Estimated Expiration
Denmark	2343299
European Patent Office	2173752
Norway	2019025
Spain	2575797

Supplementary Protection Certificates for ruxolitinib phosphate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1966202	C 2013 005	Romania		PRODUCT NAME: RUXOLITINIB SAU O SARE FARMACEUTIC ACCEPTABILA AACESTUIA; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/773/001, RO EU/1/12/773/002, RO EU/1/12/773/003; DATE OF NATIONAL AUTHORISATION: 20120823; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/773/001, EMEA EU/1/12/773/002, EMEA EU/1/12/773/003; DATE OF FIRST AUTHORISATION IN EEA: 20120823
1966202	C20130003 00072	Estonia		PRODUCT NAME: RUKSOLITINIIB;REG NO/DATE: K(2012)6018 LOPLIK 23.08.2012
2455382	CR 2017 00018	Denmark		PRODUCT NAME: RUXOLITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER RUXOLITINIB FOSFAT; REG. NO/DATE: EU/1/12/773/001-016/C(2015)1740 20150313
2455382	LUC00016	Luxembourg		PRODUCT NAME: RUXOLITINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/12/773/001-016 20150313

Market Dynamics and Financial Trajectory of Ruxolitinib Phosphate

Introduction

Ruxolitinib phosphate, marketed under the brand names Jakafi (US) and Jakavi (foreign), is a Janus kinase (JAK) inhibitor that has been making significant waves in the pharmaceutical industry. This article delves into the market dynamics and financial trajectory of this drug, highlighting its growth, applications, and future projections.

What is Ruxolitinib Phosphate?

Ruxolitinib phosphate is an anticancer drug and a potent inhibitor of JAK1 and JAK2, tyrosine kinases involved in cytokine signaling and hematopoiesis. It is primarily used to treat myeloproliferative neoplasms such as myelofibrosis and polycythemia vera, as well as steroid-refractory acute graft-versus-host disease in adults and children[3][4].

Market Growth and Projections

The Ruxolitinib Phosphate Market has experienced swift and substantial growth in recent years. The market is projected to continue its upward trajectory from 2023 to 2031, driven by strong growth rates across various segments. Here are some key points:

• Market Size and Segmentation: The market is segmented by type (5.0 Mg/Tablet, 10.0 Mg/Tablet, Other) and application (Hospital, Clinic, Other), with geographical regions including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The report indicates a positive outlook with sustained expansion projected over the forecast period[1].
• Revenue Projections: The market is expected to see significant revenue growth, with detailed analyses providing insights into the development of the market in terms of revenue throughout the prognosis period from 2023 to 2031[1].

Financial Performance

Incyte, the primary company behind Jakafi (ruxolitinib), has reported robust financial results driven by the sustained performance of this drug.

• Quarterly Revenues: In the third quarter of 2023, Incyte reported total revenues of $919 million, a 12% year-over-year increase. Jakafi net product revenues were $636 million, up 3% year-over-year, while Opzelura (ruxolitinib cream) revenues grew 141% to $92 million, driven by increased patient demand and expanded payer coverage[2][5].
• Annual Guidance: The full-year 2023 guidance for Jakafi revenues was tightened to a range of $2.59 billion to $2.62 billion, reflecting the strong demand and growth in patient numbers across all indications[2][5].

Drivers of Growth

Several factors are driving the growth of the Ruxolitinib Phosphate Market:

• Increasing Patient Demand: The growth in patient demand for Jakafi and Opzelura is a significant driver. This is attributed to the drug's efficacy in treating myeloproliferative neoplasms and other conditions such as atopic dermatitis and vitiligo[2][5].
• Expanded Payer Coverage: Enhanced payer coverage, including the listing of Opzelura as a Preferred Brand on CVS Caremark and Aetna formularies, has significantly boosted the market. This change impacts roughly 30 million commercial lives in the U.S.[2][5].
• Clinical Pipeline: Ongoing clinical trials and combination studies, such as those evaluating ruxolitinib with zilurgisertib (ALK2) and INCB57643 (BET), are expected to provide additional data and potentially expand the drug's indications[5].

Market Dynamics

The market dynamics of Ruxolitinib Phosphate are influenced by several key factors:

• Competitive Landscape: The competitive landscape includes major players such as Novartis, Incyte, CMS, Medichem S.A, and Orifarm Group. These companies are involved in various market-related activities, including new product launches, collaborations, and mergers and acquisitions[1].
• Porter's 5 Forces Framework: An analysis using Porter's 5 Forces Framework reveals the bargaining power of suppliers, buyers, and the threat of new entrants and substitutes, which collectively influence the market's competitive intensity[1].
• Macroeconomic and Regulatory Factors: Macroeconomic scrutiny and regulatory changes, such as the Small Biotech Exception qualification for ruxolitinib phosphate, also play a crucial role in shaping the market[2].

Challenges and Opportunities

Despite the positive outlook, the market faces several challenges and opportunities:

• Challenges: The market is not without its challenges, including the potential for side effects, competition from other JAK inhibitors, and regulatory hurdles. For instance, ruxolitinib was not approved for treating COVID-19 due to its failure to meet primary endpoints in phase III clinical trials[3].
• Opportunities: The ongoing clinical trials and the potential for new indications offer significant opportunities for growth. The drug's investigation for other inflammatory skin conditions and its use in combination therapies are promising areas[3][5].

Key Players and Their Strategies

Key players in the Ruxolitinib Phosphate Market are adopting various strategies to maintain and expand their market presence:

• Incyte: Incyte continues to focus on expanding the indications for Jakafi and Opzelura, while also enhancing payer coverage. The company is also investing in its clinical pipeline to explore new uses for ruxolitinib[2][5].
• Other Players: Companies like Novartis and Medichem S.A are involved in the production and distribution of ruxolitinib phosphate, ensuring a robust supply chain and competitive pricing strategies[1].

Regional Analysis

The market for Ruxolitinib Phosphate is geographically diverse, with different regions contributing to its overall growth:

• North America: This region is a significant market due to high healthcare spending and advanced healthcare infrastructure. The approval and listing of Opzelura on major formularies in the U.S. have been particularly beneficial[2][5].
• Europe and Asia-Pacific: These regions also show promising growth, driven by increasing awareness and adoption of JAK inhibitors for various indications[1].

Future Outlook

The future outlook for the Ruxolitinib Phosphate Market is positive, with several factors contributing to its anticipated growth:

• Increasing Prevalence of Target Diseases: The rising prevalence of myeloproliferative neoplasms and other conditions treated by ruxolitinib will continue to drive demand.
• Advancements in Clinical Trials: Ongoing and future clinical trials are expected to expand the drug's indications and improve its market position[5].

"Ruxolitinib phosphate qualified for the Small Biotech Exception. Beginning January 1, 2024, Opzelura will be listed as a Preferred Brand on the CVS Caremark and Aetna formularies impacting roughly 30 million commercial lives in the U.S."[2]

Key Takeaways

• The Ruxolitinib Phosphate Market is experiencing significant growth driven by increasing patient demand and expanded payer coverage.
• Incyte's financial performance has been robust, with Jakafi and Opzelura contributing substantially to revenues.
• The market is influenced by a competitive landscape, macroeconomic factors, and regulatory changes.
• Ongoing clinical trials and potential new indications offer opportunities for further growth.
• Regional analysis highlights the importance of North America, Europe, and Asia-Pacific in the market's overall performance.

FAQs

What is Ruxolitinib Phosphate used for?

Ruxolitinib phosphate is used to treat myeloproliferative neoplasms such as myelofibrosis and polycythemia vera, as well as steroid-refractory acute graft-versus-host disease in adults and children. It is also used in the form of a cream (Opzelura) to treat atopic dermatitis and vitiligo[3][4].

Who are the key players in the Ruxolitinib Phosphate Market?

Key players include Incyte, Novartis, CMS, Medichem S.A, and Orifarm Group[1].

What are the drivers of growth for the Ruxolitinib Phosphate Market?

Drivers include increasing patient demand, expanded payer coverage, and ongoing clinical trials to explore new indications[2][5].

How has Incyte's financial performance been impacted by Ruxolitinib Phosphate?

Incyte has reported significant revenue growth driven by the sustained performance of Jakafi and the increasing contribution from Opzelura, with total revenues of $919 million in the third quarter of 2023[2][5].

What are the potential challenges facing the Ruxolitinib Phosphate Market?

Challenges include potential side effects, competition from other JAK inhibitors, and regulatory hurdles. For example, ruxolitinib was not approved for treating COVID-19 due to its failure to meet primary endpoints in phase III clinical trials[3].

What is the future outlook for the Ruxolitinib Phosphate Market?

The future outlook is positive, driven by increasing prevalence of target diseases, advancements in clinical trials, and expanded indications for the drug[1][5].

Sources

1. Market Research Intellect - Global Ruxolitinib Phosphate Market Size, Trends and Projections[1].
2. Incyte - Incyte Reports 2023 Third Quarter Financial Results and Provides Updates on Key Clinical Programs[2].
3. DrugBank Online - Ruxolitinib phosphate[3].
4. NCI Drug Dictionary - Definition of ruxolitinib phosphate[4].
5. Incyte - Incyte Reports 2023 Third Quarter Financial Results and Provides Updates on Key Clinical Programs[5].