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CIBINQO Drug Patent Profile

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

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

This drug has sixty-five patent family members in forty-four countries.

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

DrugPatentWatch^® Generic Entry Outlook for Cibinqo

Cibinqo will be eligible for patent challenges on January 14, 2026. 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 February 19, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for CIBINQO

International Patents:	65
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	2
Patent Applications:	46
Drug Prices:	Drug price information for CIBINQO
What excipients (inactive ingredients) are in CIBINQO?	CIBINQO excipients list
DailyMed Link:	CIBINQO at DailyMed

See drug prices for CIBINQO

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

NDA:

213871

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 CIBINQO

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

Sponsor	Phase
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2
Pfizer	Phase 2
Innovaderm Research Inc.	Phase 4

See all CIBINQO clinical trials

Pharmacology for CIBINQO

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for CIBINQO

CIBINQO is protected by three US patents and two FDA Regulatory Exclusivities.

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	CIBINQO	abrocitinib	TABLET;ORAL	213871-001	Jan 14, 2022		RX	Yes	No
Pfizer	CIBINQO	abrocitinib	TABLET;ORAL	213871-002	Jan 14, 2022		RX	Yes	No			Y	Y
Pfizer	CIBINQO	abrocitinib	TABLET;ORAL	213871-001	Jan 14, 2022		RX	Yes	No

EU/EMA Drug Approvals for CIBINQO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Cibinqo	abrocitinib	EMEA/H/C/005452 Cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.	Authorised	no	no	no	2021-12-09

International Patents for CIBINQO

When does loss-of-exclusivity occur for CIBINQO?

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

Argentina

Australia

Brazil

Canada

Chile

China

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Moldova, Republic of

Montenegro

Morocco

Netherlands

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Turkey

Ukraine

Uruguay

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 CIBINQO around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	201443055	Pyrrolo[2,3-d]pyrimidine derivatives
Norway	3052752
Poland	2958921

Supplementary Protection Certificates for CIBINQO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2958921	122022000007	Germany		PRODUCT NAME: ABROCITINIB, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1593 20211209
2958921	CA 2022 00003	Denmark		PRODUCT NAME: ABROCITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1593 20211210
2958921	2022C/505	Belgium		PRODUCT NAME: ABROCITINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1593 20211210

CIBINQO Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Cibinqo

Introduction to Cibinqo

Cibinqo, also known as abrocitinib, is a Janus kinase 1 (JAK1) inhibitor developed by Pfizer for the treatment of moderate-to-severe atopic dermatitis (AD) in adults. The drug has garnered significant attention due to its efficacy and the growing demand for effective treatments for this chronic and debilitating skin condition.

Regulatory Approvals and Market Entry

Cibinqo received its first approval in the UK in September 2021, followed by approvals from the European Commission in December 2021, and finally from the FDA in January 2022[1][4].

FDA Approval

The FDA approved Cibinqo in 100-mg and 200-mg doses, with a 50-mg dose option for patients with moderate kidney failure. This approval was based on data from five clinical trials involving over 1,600 patients, which demonstrated the drug's efficacy in clearing skin, improving itch, and managing the extent and severity of eczema[1][4].

Market Need and Competition

Prevalence of Atopic Dermatitis

Atopic dermatitis affects approximately 5% to 10% of adults in the U.S., with about one in three experiencing moderate-to-severe symptoms. This condition significantly impacts patients' daily lives and emotional well-being, making effective treatments crucial[1].

Competitive Landscape

Cibinqo enters a market dominated by other JAK inhibitors, such as Sanofi and Regeneron’s Dupixent, which has been highly successful, generating about 6 billion euros in the third quarter of 2021. AbbVie’s Rinvoq is another competitor in this space, approved for patients with moderate-to-severe atopic dermatitis who are at least 12 years old[1][4].

Financial Projections and Performance

Peak Sales Projections

Pfizer's CEO, Albert Bourla, initially projected that Cibinqo could generate $3 billion in peak sales. Later, analysts from SVB Leerink estimated that the drug would generate $2 billion by 2027[1][4].

Revenue Growth

The approval and subsequent marketing of Cibinqo are expected to contribute to Pfizer's operational revenue growth. In 2023, Pfizer forecasted a 7% to 9% operational revenue growth, excluding revenues from COVID-19 products and the impact of foreign exchange. Cibinqo, along with other new product launches, is anticipated to be a significant contributor to this growth[3].

Clinical Efficacy and Safety

Clinical Trials

Cibinqo has been evaluated in multiple large-scale clinical trials, demonstrating strong efficacy in clearing skin, improving itch, and managing the extent and severity of eczema. The drug showed rapid improvement in itch after just two weeks of treatment[1][4].

Safety Profile

The most common adverse events reported with Cibinqo include nasopharyngitis, nausea, and headache. However, it is worth noting that JAK inhibitors, in general, have been associated with a potentially elevated risk of cardiovascular complications, leading to updated safety warnings from the FDA[1][4].

Marketing and Patient Awareness

Direct-to-Consumer Campaigns

Pfizer introduced a direct-to-consumer campaign in November 2022 to increase patient awareness of Cibinqo. This campaign has led to more patients inquiring about the drug with their healthcare providers, indicating a positive impact on market penetration[3].

Long-Term Growth Prospects

Pipeline and Business Development

Pfizer's long-term growth strategy includes a robust pipeline of new products and business development activities. The company expects that new launches, including Cibinqo, will help offset the expected losses from the patent expirations of other products between 2025 and 2030. Pfizer anticipates that these new launches could generate up to $20 billion in risk-adjusted revenues by 2030[3].

Financial Performance and Cost Savings

In 2023, Pfizer reported a decline in revenues primarily due to the decrease in COVID-19 product sales. However, excluding these products, the company saw an 8% operational revenue growth. Pfizer is also on track to deliver significant cost savings through its cost realignment program, aiming for at least $4 billion in annual net cost savings by the end of 2024[5].

Key Takeaways

• Regulatory Approvals: Cibinqo has received approvals in the UK, Europe, and the U.S., marking its entry into a competitive market.
• Market Need: The drug addresses a significant unmet need for effective treatments for moderate-to-severe atopic dermatitis.
• Financial Projections: Projected to generate $2 billion by 2027, contributing to Pfizer's overall revenue growth.
• Clinical Efficacy: Demonstrated strong efficacy in clinical trials, with rapid improvement in symptoms.
• Safety Profile: Common adverse events include nasopharyngitis, nausea, and headache, with a noted risk of cardiovascular complications.
• Marketing Efforts: Direct-to-consumer campaigns have increased patient awareness and inquiries.
• Long-Term Growth: Expected to contribute to Pfizer's long-term revenue growth and help offset patent expiration losses.

FAQs

Q: What is Cibinqo used for?

A: Cibinqo is used for the treatment of moderate-to-severe atopic dermatitis in adults.

Q: When was Cibinqo approved by the FDA?

A: Cibinqo was approved by the FDA in January 2022.

Q: What are the common adverse events associated with Cibinqo?

A: The most common adverse events include nasopharyngitis, nausea, and headache.

Q: How does Cibinqo compare to other treatments in the market?

A: Cibinqo competes with other JAK inhibitors like Dupixent and Rinvoq, but has shown strong efficacy in clinical trials.

Q: What are the financial projections for Cibinqo?

A: Cibinqo is projected to generate $2 billion by 2027 and contribute to Pfizer's overall revenue growth.

Sources

1. Biospace: "Another Atopic Dermatitis Drug Hits the Market as FDA Okays Pfizer's Cibinqo"[1]
2. Biospace: "Pfizer Reports First-Quarter 2023 Results"[2]
3. Pfizer: "Fourth-Quarter 2022 Earnings Conference Call Prepared Remarks"[3]
4. Drug Discovery Trends: "FDA approves Pfizer's JAK1 inhibitor Cibinqo for moderate-to-severe atopic dermatitis"[4]
5. Pfizer: "Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Financial Guidance"[5]