You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 23, 2024

~ Buy the OPZELURA (ruxolitinib phosphate) Drug Profile, 2024 PDF Report in the Report Store ~

OPZELURA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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 twenty-eight patent family members in forty-eight 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

< Available with Subscription >

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for OPZELURA?
  • What are the global sales for OPZELURA?
  • What is Average Wholesale Price for OPZELURA?
Drug patent expirations by year for OPZELURA
Drug Prices for OPZELURA

See drug prices for OPZELURA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OPZELURA
Generic Entry Date for OPZELURA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Incyte CorporationPhase 3
Incyte CorporationPhase 2

See all OPZELURA clinical trials

Pharmacology for OPZELURA
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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of OPZELURA is ⤷  Subscribe.

This potential generic entry date is based on patent ⤷  Subscribe.

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Incyte Corp OPZELURA ruxolitinib phosphate CREAM;TOPICAL 215309-001 Sep 21, 2021 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Incyte Corp OPZELURA ruxolitinib phosphate CREAM;TOPICAL 215309-001 Sep 21, 2021 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Incyte Corp OPZELURA ruxolitinib phosphate CREAM;TOPICAL 215309-001 Sep 21, 2021 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 08266183
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 0814254
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 89663
Estimated Expiration: ⤷  Subscribe

China

Patent: 1932582
Estimated Expiration: ⤷  Subscribe

Patent: 3524509
Estimated Expiration: ⤷  Subscribe

Colombia

Patent: 51256
Estimated Expiration: ⤷  Subscribe

Costa Rica

Patent: 151
Estimated Expiration: ⤷  Subscribe

Croatia

Patent: 0140541
Estimated Expiration: ⤷  Subscribe

Patent: 0160717
Estimated Expiration: ⤷  Subscribe

Patent: 0190385
Estimated Expiration: ⤷  Subscribe

Cuba

Patent: 933
Estimated Expiration: ⤷  Subscribe

Patent: 179
Estimated Expiration: ⤷  Subscribe

Patent: 090213
Estimated Expiration: ⤷  Subscribe

Patent: 120155
Estimated Expiration: ⤷  Subscribe

Cyprus

Patent: 15145
Estimated Expiration: ⤷  Subscribe

Patent: 17693
Estimated Expiration: ⤷  Subscribe

Patent: 21338
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 73752
Estimated Expiration: ⤷  Subscribe

Patent: 40731
Estimated Expiration: ⤷  Subscribe

Patent: 70090
Estimated Expiration: ⤷  Subscribe

Dominican Republic

Patent: 009000280
Estimated Expiration: ⤷  Subscribe

Ecuador

Patent: 099802
Estimated Expiration: ⤷  Subscribe

Eurasian Patent Organization

Patent: 9784
Estimated Expiration: ⤷  Subscribe

Patent: 1070013
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 73752
Estimated Expiration: ⤷  Subscribe

Patent: 40731
Estimated Expiration: ⤷  Subscribe

Patent: 70090
Estimated Expiration: ⤷  Subscribe

Patent: 95369
Estimated Expiration: ⤷  Subscribe

Patent: 11883
Estimated Expiration: ⤷  Subscribe

Georgia, Republic of

Patent: 0125533
Estimated Expiration: ⤷  Subscribe

Guatemala

Patent: 0900314
Estimated Expiration: ⤷  Subscribe

Hong Kong

Patent: 43161
Estimated Expiration: ⤷  Subscribe

Patent: 98652
Estimated Expiration: ⤷  Subscribe

Hungary

Patent: 29236
Estimated Expiration: ⤷  Subscribe

Patent: 43732
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 2524
Estimated Expiration: ⤷  Subscribe

Patent: 4276
Estimated Expiration: ⤷  Subscribe

Patent: 0401
Estimated Expiration: ⤷  Subscribe

Patent: 7708
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 75653
Estimated Expiration: ⤷  Subscribe

Patent: 10529209
Estimated Expiration: ⤷  Subscribe

Lithuania

Patent: 70090
Estimated Expiration: ⤷  Subscribe

Malaysia

Patent: 4969
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 2814
Estimated Expiration: ⤷  Subscribe

Patent: 09013402
Estimated Expiration: ⤷  Subscribe

Montenegro

Patent: 960
Estimated Expiration: ⤷  Subscribe

Morocco

Patent: 517
Estimated Expiration: ⤷  Subscribe

New Zealand

Patent: 1803
Estimated Expiration: ⤷  Subscribe

Nicaragua

Patent: 0900216
Estimated Expiration: ⤷  Subscribe

Norway

Patent: 19025
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 73752
Estimated Expiration: ⤷  Subscribe

Patent: 40731
Estimated Expiration: ⤷  Subscribe

Patent: 70090
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 73752
Estimated Expiration: ⤷  Subscribe

Patent: 70090
Estimated Expiration: ⤷  Subscribe

San Marino

Patent: 201000002
Patent: Sali dell'inibitore di chinasi janus (r)-3-(4-(7h-pirrolo[2,3-d]pirimidin-4-il)-1h-pirazoli-1-il)-3-ciclopentilpropanonitrile
Estimated Expiration: ⤷  Subscribe

Patent: 01000002
Patent: Sali dell'inibitore di chinasi janus (R)-3-(4-(7H-pirrolo[2,3-D]pirimidin-4-IL)-1H-pirazoli-1-IL)-3-ciclopentilpropanonitrile
Estimated Expiration: ⤷  Subscribe

Serbia

Patent: 245
Patent: SOLI INHIBITORA JANUS KINAZE (R)-3-(4-(7H-PIROLO(2,3-D) PIRIMIDIN-4-IL)-1H-PIRAZOL-1-IL)-3-CIKLOPENTILPROPAN-NITRILA (SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO(2,3-D)PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE)
Estimated Expiration: ⤷  Subscribe

Patent: 878
Patent: KRISTALNE SOLI INHIBITORA JANUS KINAZE (R)-3-(4-(7H-PIROLO[2,3-D]PIRIMIDIN-4-IL)-1H-PIRAZOL-1-IL)-3-CIKLOPENTILPROPIONITRIL (CRYSTALLINE SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE)
Estimated Expiration: ⤷  Subscribe

Patent: 449
Patent: UPOTREBA SOLI INHIBITORA JANUS KINAZE (R)-3-(4-(7H-PIROLO[2,3-D]PIRIMIDIN-4-IL)-1H- PIRAZOL-1-IL)-3-CIKLOPENTILPROPIONITRILA (USE OF SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H- PYRAZOL-1-YL)-3- CYCLOPENTYLPROPANENITRILE)
Estimated Expiration: ⤷  Subscribe

Singapore

Patent: 2198
Patent: SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE
Estimated Expiration: ⤷  Subscribe

Patent: 201509887U
Patent: SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE
Estimated Expiration: ⤷  Subscribe

Patent: 201912675V
Patent: SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE
Estimated Expiration: ⤷  Subscribe

Slovenia

Patent: 73752
Estimated Expiration: ⤷  Subscribe

Patent: 40731
Estimated Expiration: ⤷  Subscribe

Patent: 70090
Estimated Expiration: ⤷  Subscribe

South Africa

Patent: 0908826
Patent: SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTHYLPROPANEITRILE
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 1549876
Estimated Expiration: ⤷  Subscribe

Patent: 100049010
Estimated Expiration: ⤷  Subscribe

Patent: 150036210
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 67665
Estimated Expiration: ⤷  Subscribe

Patent: 75797
Estimated Expiration: ⤷  Subscribe

Patent: 14092
Estimated Expiration: ⤷  Subscribe

Patent: 03444
Estimated Expiration: ⤷  Subscribe

Tunisia

Patent: 09000514
Patent: SALTS OF THE JANUS KINASE INHIBITOR (R) -3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE
Estimated Expiration: ⤷  Subscribe

Turkey

Patent: 1903488
Estimated Expiration: ⤷  Subscribe

Ukraine

Patent: 467
Patent: СОЛІ ІНГІБІТОРА ЯНУС-КІНАЗИ (R)-3-(4-(7H-ПІРОЛО[2,3-d]ПІРИМІДИН-4-ІЛ)-1H-ПІРАЗОЛ-1-ІЛ)-3-ЦИКЛОПЕНТИЛПРОПАННІТРИЛУ[СОЛИ ИНГИБИТОРА ЯНУС-КИНАЗЫ (R)-3-(4-(7H-ПИРРОЛО[2,3-d]ПИРИМИДИН-4-ИЛ)-1H-ПИРАЗОЛ-1-ИЛ)-3-ЦИКЛОПЕНТИЛПРОПАННИТРИЛА (SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-d]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE)
Estimated Expiration: ⤷  Subscribe

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
Malaysia 162590 HETEROARYL SUBSTITUTED PYRROLO[2,3-B] PYRIDINES AND PYRROLO[2,3-B] PYRIMIDINES AS JANUS KINASE INHIBITORS ⤷  Subscribe
Eurasian Patent Organization 201070013 СОЛИ ИНГИБИТОРА ЯНУС-КИНАЗЫ (R)-3-(4-(7H-ПИРРОЛО[2,3-d]ПИРИМИДИН-4-ИЛ)-1H-ПИРАЗОЛ-1-ИЛ)-3-ЦИКЛОПЕНТИЛПРОПАННИТРИЛА ⤷  Subscribe
South Korea 20220104166 ⤷  Subscribe
Singapore 10201509887U SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OPZELURA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1966202 92137 Luxembourg ⤷  Subscribe PRODUCT NAME: RUXOLITINIB,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
1966202 C01966202/01 Switzerland ⤷  Subscribe FORMER OWNER: INCYTE CORPORATION, US
2455382 CA 2017 00018 Denmark ⤷  Subscribe 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 448 Finland ⤷  Subscribe
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

OPZELURA Market Analysis and Financial Projection Experimental

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

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.