OPZELURA Drug Patent Profile

Which patents cover Opzelura, and when can generic versions of Opzelura launch?

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

This drug has three hundred and thirty-five patent family members in forty-nine countries.

The generic ingredient in OPZELURA 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 Opzelura

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 OPZELURA

International Patents:	335
US Patents:	17
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	2
Patent Applications:	394
Drug Prices:	Drug price information for OPZELURA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OPZELURA
What excipients (inactive ingredients) are in OPZELURA?	OPZELURA excipients list
DailyMed Link:	OPZELURA at DailyMed

See drug prices for OPZELURA

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

Constraining patent/regulatory exclusivity:

8,722,693*PED

NDA:

215309

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 OPZELURA

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

Sponsor	Phase
Incyte Corporation	Phase 3
Incyte Corporation	Phase 2

See all OPZELURA clinical trials

Pharmacology for OPZELURA

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

Paragraph IV (Patent) Challenges for OPZELURA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OPZELURA	Cream	ruxolitinib phosphate	1.5%	215309	1	2023-07-31

US Patents and Regulatory Information for OPZELURA

OPZELURA is protected by eighteen US patents and four 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	OPZELURA	ruxolitinib phosphate	CREAM;TOPICAL	215309-001	Sep 21, 2021		RX	Yes	Yes	11,510,923
Incyte Corp	OPZELURA	ruxolitinib phosphate	CREAM;TOPICAL	215309-001	Sep 21, 2021		RX	Yes	Yes	10,869,870*PED				Y
Incyte Corp	OPZELURA	ruxolitinib phosphate	CREAM;TOPICAL	215309-001	Sep 21, 2021		RX	Yes	Yes	11,571,425		Y
Incyte Corp	OPZELURA	ruxolitinib phosphate	CREAM;TOPICAL	215309-001	Sep 21, 2021		RX	Yes	Yes	11,590,137
Incyte Corp	OPZELURA	ruxolitinib phosphate	CREAM;TOPICAL	215309-001	Sep 21, 2021		RX	Yes	Yes	10,758,543*PED				Y
Incyte Corp	OPZELURA	ruxolitinib phosphate	CREAM;TOPICAL	215309-001	Sep 21, 2021		RX	Yes	Yes

International Patents for OPZELURA

When does loss-of-exclusivity occur for OPZELURA?

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 OPZELURA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3087972	FORMULATION TOPIQUE POUR UN INHIBITEUR JAK (TOPICAL FORMULATION FOR A JAK INHIBITOR)
Japan	5710430
Japan	2014051531	HETEROARYL SUBSTITUTED PYRROLO[2,3-b]PYRIDINE AND PYRROLO[2,3-b]PYRIMIDINE AS JANUS KINASE INHIBITORS
Mexico	2022002646	FORMULACION DE RUXOLITINIB PARA LA REDUCCION DE COMEZON EN DERMATITIS ATOPICA. (RUXOLITINIB FORMULATION FOR REDUCTION OF ITCH IN ATOPIC DERMATITIS.)
Montenegro	00960	SOLI INHIBITORA JANUS KINAZE, (R)-3-(4-(7H-PIROL[2,3-D]PIRIMIDIN-4-IL)-1H-PIRAZOL-1-IL)-3-CIKLOPENTILPROPANNITRILA (SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE)
Portugal	2426129

Supplementary Protection Certificates for OPZELURA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1966202	122013000015	Germany		PRODUCT NAME: RUXOLITINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
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
2455382	300870	Netherlands		PRODUCT NAME: RUXOLITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/12/773/001-016 20150313
1966202	92137	Luxembourg		PRODUCT NAME: RUXOLITINIB,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2455382	CA 2017 00018	Denmark		PRODUCT NAME: RUXOLITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER RUXOLITINIB FOSFAT; REG. NO/DATE: C(2015)1740/EU/1/12/773/001-016 20150313
1966202	CR 2013 00005	Denmark		PRODUCT NAME: RUXOLITINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER RUXOLITINIB PHOSFAT; REG. NO/DATE: EU/1/12/773/001-003 20120823

Market Dynamics and Financial Trajectory for Opzelura

Introduction

Opzelura, a topical Janus kinase (JAK) inhibitor developed by Incyte, has been making significant waves in the pharmaceutical market since its launch. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its performance, challenges, and future prospects.

Approval and Indications

Opzelura was approved by the FDA for the treatment of atopic dermatitis and vitiligo, marking a significant milestone in the treatment of these conditions. Despite initial concerns due to FDA safety warnings, the drug has shown robust performance in the market[4].

Launch and Early Performance

The launch of Opzelura was deemed "very successful" by Incyte's CEO, Hervé Hoppenot. In the initial months post-launch, the drug captured 10% of the new-to-brand post-steroid market share, competing closely with established players like Pfizer’s Eucrisa and Sanofi and Regeneron’s Dupixent[4].

Market Share and Prescription Trends

Opzelura quickly gained traction among healthcare providers. By the end of 2022, it had reached nearly 19,000 patients, and doctors indicated a willingness to prescribe the drug to more patients. In a survey, U.S. doctors reported an intention to start prescribing Opzelura to an average of 6.9 patients in February 2023, up from 3.7 in January 2023[4].

Financial Performance

Quarterly and Annual Revenues

In the fourth quarter of 2023, Opzelura generated $109 million in net product revenues, representing a 78% increase year-over-year. This growth was driven by increased patient demand, refills, and expanded payer coverage. For the full year 2023, Opzelura's net product revenues reached $338 million, a 162% increase over the prior year[1][5].

Year-over-Year Growth

The drug's revenue has shown consistent growth. In the first quarter of 2023, Opzelura's net product revenues were $57 million, a 343% increase year-over-year, driven by increased patient demand and expanded coverage[2].

Seasonal Dynamics

Opzelura's sales are subject to seasonal fluctuations. For instance, the first-quarter 2024 sales are expected to decline sequentially due to typical seasonal dynamics[1].

Geographic Expansion

U.S. Market

Opzelura has seen strong growth in the U.S. market, with net sales reaching $119 million in the third quarter of 2024, a 35% year-over-year increase. The drug's total prescriptions (TRx) have also shown significant growth, with a 31% year-over-year increase in the third quarter of 2024[3].

International Expansion

Opzelura has also been launched in Europe, contributing to its global growth. The drug was approved in Canada for atopic dermatitis and vitiligo in October 2024, further expanding its market reach[3].

Competitive Landscape

Opzelura competes in a crowded market dominated by drugs like Dupixent from Sanofi and Regeneron, and Eucrisa from Pfizer. However, Opzelura has managed to carve out a significant share, capturing 10% of the new-to-brand post-steroid market share shortly after its launch[4].

Pricing and Discounts

One of the initial concerns was the heavy discounting of Opzelura, with an average discount rate of around 55% in 2023. However, Incyte has emphasized its focus on maximizing reported net sales rather than the discount level. Any future discounts will be aimed at improving access and driving higher net sales[1].

Future Prospects

Opzelura is expected to continue its growth trajectory. Incyte projects significant potential from near-term launches, including an FDA approval in August 2024 for third-line chronic graft-versus-host disease (GVHD), with a U.S. launch expected in the first quarter of 2025. These new indications and launches are anticipated to contribute over $800 million in incremental revenues by 2029[3].

Impact on Incyte's Financials

Opzelura's success has been a key driver of Incyte's financial performance. The company crossed the $1 billion threshold in quarterly revenues for the first time, largely due to the strong performance of Opzelura and its sister drug, Jakafi[1].

Conclusion

Opzelura has demonstrated a robust market performance since its launch, driven by strong patient demand, expanded payer coverage, and successful geographic expansion. Despite initial challenges and competitive pressures, the drug has established itself as a significant player in the treatment of atopic dermatitis and vitiligo. As Incyte continues to focus on maximizing net sales and expanding the drug's indications, Opzelura is poised for continued growth and success.

Key Takeaways

• Strong Launch: Opzelura had a successful launch, capturing 10% of the new-to-brand post-steroid market share.
• Revenue Growth: The drug generated $338 million in net product revenues in 2023, with a 78% year-over-year increase in the fourth quarter.
• Geographic Expansion: Opzelura has been launched in the U.S., Europe, and Canada, contributing to its global growth.
• Competitive Landscape: Despite competition, Opzelura has carved out a significant market share.
• Future Prospects: The drug is expected to contribute over $800 million in incremental revenues by 2029 from new indications and launches.

FAQs

Q: What are the approved indications for Opzelura? A: Opzelura is approved for the treatment of atopic dermatitis and vitiligo.

Q: How has Opzelura performed in terms of market share? A: Opzelura has captured 10% of the new-to-brand post-steroid market share and is competing closely with established drugs like Eucrisa and Dupixent.

Q: What were the net product revenues for Opzelura in the fourth quarter of 2023? A: Opzelura generated $109 million in net product revenues in the fourth quarter of 2023, a 78% increase year-over-year.

Q: How does Opzelura's pricing strategy impact its sales? A: Despite initial heavy discounting, Incyte focuses on maximizing reported net sales rather than the discount level, aiming to improve access and drive higher net sales.

Q: What are the future growth prospects for Opzelura? A: Opzelura is expected to contribute over $800 million in incremental revenues by 2029 from new indications and launches, including an FDA approval for third-line chronic GVHD.

Sources

1. https://www.fiercepharma.com/pharma/incyte-crosses-1b-quarterly-revenue-first-time-jakafi-faces-against-gsk-rival
2. https://www.biospace.com/incyte-reports-2023-first-quarter-financial-results-and-provides-updates-on-key-clinical-programs
3. https://investor.incyte.com/static-files/f714c980-2fa8-4d6e-8570-8b1dbd73f225
4. https://www.fiercepharma.com/marketing/incyte-s-eczema-cream-opzelura-ladened-fda-warning-off-to-very-successful-launch-ceo
5. https://investor.incyte.com/news-releases/news-release-details/incyte-reports-2023-fourth-quarter-and-year-end-financial