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JAKAFI Drug Patent Profile

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

Jakafi is a drug marketed by Incyte Corp and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and thirty-three patent family members in forty-six countries.

The generic ingredient in JAKAFI is ruxolitinib phosphate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ruxolitinib phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Jakafi

Jakafi was eligible for patent challenges on November 16, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 12, 2028. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for JAKAFI

International Patents:	233
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	80
Patent Applications:	394
Drug Prices:	Drug price information for JAKAFI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JAKAFI
What excipients (inactive ingredients) are in JAKAFI?	JAKAFI excipients list
DailyMed Link:	JAKAFI at DailyMed

See drug prices for JAKAFI

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

Constraining patent/regulatory exclusivity:

8,722,693*PED

NDA:

202192

Dosage:

TABLET;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.

Recent Clinical Trials for JAKAFI

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

Sponsor	Phase
City of Hope Medical Center	Phase 2
Washington University School of Medicine	Phase 1
Karyopharm Therapeutics Inc	Phase 2

See all JAKAFI clinical trials

Pharmacology for JAKAFI

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

Paragraph IV (Patent) Challenges for JAKAFI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 JAKAFI

JAKAFI is protected by eight US patents and eight FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 8,722,693.

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
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-005	Nov 16, 2011		RX	Yes	Yes
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-003	Nov 16, 2011		RX	Yes	No
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-002	Nov 16, 2011		RX	Yes	No
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-004	Nov 16, 2011		RX	Yes	No	8,722,693*PED				Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-004	Nov 16, 2011		RX	Yes	No
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-003	Nov 16, 2011		RX	Yes	No
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-004	Nov 16, 2011		RX	Yes	No	8,822,481*PED				Y

International Patents for JAKAFI

When does loss-of-exclusivity occur for JAKAFI?

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

Australia

Brazil

Canada

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Guatemala

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Nicaragua

Norway

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Tunisia

Turkey

Ukraine

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 JAKAFI around the world.

Country	Patent Number	Title	Estimated Expiration
Nicaragua	200900216	SALES DE INHIBIDOR DE JANUS CINASA ( R ) - ( 3 ) - ( 4 - ( 7H - PIRROLO [ 2,3-D ] PIRIMIDIN - 4 - IL ) - 1H - PIRAZOL - 1 - IL) - 3 - CICLOPENTILPROPANENITRILO.
Hungary	E028588
New Zealand	762863	Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors
Japan	2014051531	HETEROARYL SUBSTITUTED PYRROLO[2,3-b]PYRIDINE AND PYRROLO[2,3-b]PYRIMIDINE AS JANUS KINASE INHIBITORS
European Patent Office	3184526	DERIVES DE PYRROLO [2,3-D] PYRIMIDINE EN TANT QU'INHIBITEURS DE JANUS KINASE (PYRROLO[2,3-D]PYRIMIDINE DERIVATIVES AS JANUS KINASE INHIBITOR)
Cyprus	2013006
France	17C1013

Supplementary Protection Certificates for JAKAFI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1966202	1390005-5	Sweden		PRODUCT NAME: RUXOLITINIB, ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/12/773/001; 2012-08-23; PERIOD OF VALIDITY (FROM - UNTIL): 2026-12-13 - 2027-08-27
1966202	145 1-2013	Slovakia		FORMER OWNER: INCYTE CORPORATION, WILMINGTON, DE, US;
1966202	PA2013002,C1966202	Lithuania		PRODUCT NAME: RUXOLITINIBUM; REGISTRATION NO/DATE: EU/1/12/773/001-EU/1/12/773/003, 0120823
1966202	122013000015	Germany		PRODUCT NAME: RUXOLITINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
1966202	448	Finland
2455382	17C1013	France		PRODUCT NAME: RUXOLITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/773/001-016 20150313

JAKAFI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for JAKAFI

Introduction

JAKAFI (ruxolitinib), developed by Incyte, is a Janus kinase (JAK) inhibitor that has been a cornerstone in the treatment of various hematological disorders, including myelofibrosis, polycythemia vera, and graft-versus-host disease. Here, we delve into the market dynamics and financial trajectory of JAKAFI, examining its performance, competitive landscape, and future outlook.

Market Performance of JAKAFI

Quarterly Revenue Growth

In the fourth quarter of 2023, Incyte achieved a significant milestone with JAKAFI, crossing the $1 billion threshold in quarterly revenues for the first time. JAKAFI generated $695 million in sales, although this was slightly below analysts' expectations. However, the drug still demonstrated a 7% year-over-year growth[1].

In the third quarter of 2024, JAKAFI continued to show strong performance, with net product revenues of $741 million, representing a 16% year-over-year increase. This growth was driven by increased patient demand across all indications[2].

Annual Sales Projections

Incyte projects JAKAFI sales to grow from $2.59 billion in 2023 to a range between $2.69 billion and $2.75 billion in 2024. The company is optimistic about reaching its target of $3 billion in sales by 2028, partly due to the anticipated impact of the new $2,000 out-of-pocket cap for Medicare Part D under the Inflation Reduction Act[1].

Competitive Landscape

Entry of New JAK Inhibitors

The market for JAK inhibitors is becoming increasingly competitive with the launch of new drugs. GSK's Ojjaara, approved for anemic myelofibrosis, is a significant competitor. Despite Ojjaara's strong uptake, with 750 patients and a 15% share in the anemic population, JAKAFI maintained around 53-54% of the total myelofibrosis market share and 60-63% of new patient share from September to December 2023[1].

Other competitors include Bristol Myers Squibb’s Inrebic and CTI BioPharma’s Vonjo, though these have had minimal impact on JAKAFI's market share and sales[4].

Differentiation and Market Position

JAKAFI remains the only drug to have shown superior overall survival in myelofibrosis, regardless of the patient’s anemia status. This strong designation gives Incyte confidence in maintaining its leadership in the myelofibrosis market. Additionally, JAKAFI's label has no line restrictions or anemia status requirements, which is a significant advantage over competitors like Ojjaara[4].

Financial Impact of Competitive Dynamics

Revenue and Market Share

Despite the entry of new competitors, JAKAFI has continued to generate substantial revenue. The drug's resilience is attributed to its established market presence and the lack of significant market share erosion by new entrants. For instance, in the third quarter of 2024, JAKAFI's net product revenues grew by 16%, driven by increased patient demand[2].

Operating Expenses and Profitability

Incyte's financial performance is closely tied to JAKAFI's sales. For the third quarter of 2024, Incyte reported total GAAP revenues of $1.137 billion, with a GAAP operating income of $146 million. Non-GAAP operating income was $255 million, reflecting the company's ability to maintain profitability despite increasing competition[2].

Future Outlook and Strategies

Addressing Patent Cliff

JAKAFI faces a patent cliff in 2028, which poses a significant challenge. Incyte is working on several strategies to mitigate this impact, including the development of an extended-release version of JAKAFI, although this was recently rejected by the FDA. The company is addressing the FDA's concerns and is confident in resolving them before the patent cliff[4].

Expanding Indications

Incyte is also focusing on expanding JAKAFI's indications. For example, recent clinical data showed that JAKAFI reduced the risk of major thrombosis by 44% in patients with polycythemia vera who cannot take hydroxycarbamide. This new indication is expected to be a key growth driver for the drug[4].

Novel Combinations

The company is exploring novel combinations involving JAKAFI, such as monotherapy and combination data for its ALK2 inhibitor zilurgisertib and BET inhibitor INCB57643. These efforts aim to enhance JAKAFI's therapeutic profile and maintain its market dominance[4].

Regulatory and Policy Impact

Medicare Part D Changes

The new $2,000 out-of-pocket cap for Medicare Part D, set to go into effect in 2025 under the Inflation Reduction Act, is expected to positively impact JAKAFI sales. This policy change could encourage patients who previously could not afford the drug to opt into JAKAFI therapy, thereby increasing its market reach[1].

Key Takeaways

• Revenue Growth: JAKAFI has consistently shown year-over-year revenue growth, despite facing competition from new JAK inhibitors.
• Market Share: JAKAFI maintains a significant market share in myelofibrosis, with around 53-54% of the total market and 60-63% of new patient share.
• Competitive Landscape: New competitors like GSK's Ojjaara pose a threat, but JAKAFI's superior overall survival benefit and lack of line restrictions or anemia status requirements maintain its market leadership.
• Future Strategies: Incyte is focusing on expanding indications, developing novel combinations, and addressing the upcoming patent cliff to ensure JAKAFI's continued success.
• Regulatory Impact: Changes in Medicare Part D policies are expected to boost JAKAFI sales by making the drug more affordable for patients.

FAQs

Q: What are the current sales projections for JAKAFI in 2024?

A: Incyte projects JAKAFI sales to grow from $2.59 billion in 2023 to a range between $2.69 billion and $2.75 billion in 2024[1].

Q: How is JAKAFI performing against new competitors like GSK's Ojjaara?

A: Despite the entry of Ojjaara, JAKAFI has maintained around 53-54% of the total myelofibrosis market share and 60-63% of new patient share from September to December 2023[1].

Q: What strategies is Incyte employing to address the patent cliff for JAKAFI in 2028?

A: Incyte is working on developing an extended-release version of JAKAFI, expanding its indications, and exploring novel combinations to mitigate the impact of the patent cliff[4].

Q: How will the new Medicare Part D policy impact JAKAFI sales?

A: The new $2,000 out-of-pocket cap for Medicare Part D is expected to make JAKAFI more affordable, potentially increasing sales as more patients opt into the therapy[1].

Q: What are the key growth drivers for JAKAFI in the future?

A: The key growth drivers include expanding indications, such as polycythemia vera, and the potential impact of the new Medicare Part D policy[4].

Sources

1. FiercePharma: "Amid GSK showdown, Incyte crosses $1B in quarterly revenue"
2. Incyte Investor Relations: "Incyte Reports 2024 Third Quarter Financial Results and Provides"
3. GlobeNewswire: "JAKAFI (Ruxolitinib) Emerging Drug Insights and Market Forecasts - 2032"
4. FiercePharma: "Battling new rivals and bracing for Jakafi's patent cliff, Incyte shores up resilience with new disease and combo strategies"