Abrocitinib - Generic Drug Details

What are the generic sources for abrocitinib and what is the scope of patent protection?

Abrocitinib is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Two suppliers are listed for this compound.

Summary for abrocitinib

International Patents:	65
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	14
Patent Applications:	115
What excipients (inactive ingredients) are in abrocitinib?	abrocitinib excipients list
DailyMed Link:	abrocitinib at DailyMed

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

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 abrocitinib

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

Sponsor	Phase
Peng Zhang	Early Phase 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2
William Damsky	Phase 2

See all abrocitinib clinical trials

Pharmacology for abrocitinib

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

Anatomical Therapeutic Chemical (ATC) Classes for abrocitinib

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

US Patents and Regulatory Information for abrocitinib

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

EU/EMA Drug Approvals for abrocitinib

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 abrocitinib

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

Supplementary Protection Certificates for abrocitinib

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

Abrocitinib Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Abrocitinib

Introduction

Abrocitinib, marketed as Cibinqo by Pfizer, is a Janus kinase (JAK) inhibitor that has been approved for the treatment of moderate-to-severe atopic dermatitis (AD). Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its potential, competitive landscape, and economic evaluations.

Market Potential and Expansion

Abrocitinib is poised for significant market expansion, particularly in the seven major markets including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. The drug's approval and subsequent market performance are expected to drive substantial growth in the atopic dermatitis treatment market.

• Projected Sales: Analysts project that Cibinqo could generate up to $3 billion in peak sales, with more conservative estimates suggesting $2 billion by 2027[3].
• Market Forecast: Detailed market assessments and forecasts indicate that abrocitinib will see considerable sales growth from 2028 to 2032, driven by its efficacy and the growing demand for effective AD treatments[1].

Competitive Landscape

The competitive landscape for atopic dermatitis treatments is robust, with several JAK inhibitors and biological therapies vying for market share.

• Key Competitors: Abrocitinib competes with other JAK inhibitors such as dupilumab, tralokinumab, baricitinib, and upadacitinib. However, studies suggest that abrocitinib is cost-effective and offers significant clinical benefits compared to these alternatives[2][4].
• Clinical Trials and Efficacy: Clinical trials have shown that abrocitinib achieves higher response rates in terms of Eczema Area and Severity Index (EASI) scores and Investigator Global Assessment (IGA) responses compared to placebo and some competitors[5].

Cost-Effectiveness and Economic Evaluations

Economic evaluations are crucial in determining the financial viability and value of abrocitinib in the healthcare system.

• Cost-Effectiveness Analysis: A study from the Spanish National Health System perspective found that abrocitinib is a cost-effective therapy compared to other JAK inhibitors and biological therapies, offering significant cost savings and quality-adjusted life-years (QALYs) gained[2].
• Annual Per-Patient Costs: The annual per-patient cost for abrocitinib is estimated at $17,777 for the 100 mg dose and $19,896 for the 200 mg dose, which is competitive with other treatments like dupilumab ($24,988 per patient)[4].
• Incremental Cost-Effectiveness Ratio (ICER): The ICER for abrocitinib compared to standard of care (SoC) and other treatments indicates that it can be cost-effective at certain willingness-to-pay thresholds, although the exact ICER values vary depending on the analysis and population considered[4].

Regulatory and Developmental Status

Abrocitinib has undergone rigorous clinical trials and regulatory reviews.

• Clinical Trials: The drug has been evaluated in several phase III trials, including the JADE MONO-1, JADE MONO-2, JADE COMPARE, and JADE TEEN trials, which have demonstrated its efficacy and safety in patients with moderate-to-severe AD[5].
• Regulatory Approvals: Abrocitinib has received approval from regulatory bodies such as the FDA, marking a significant milestone in its market entry[3].

Safety and Efficacy

The safety and efficacy of abrocitinib have been extensively studied.

• Adverse Events: Common adverse events include nasopharyngitis, nausea, and headache. Serious adverse events are relatively rare, with thrombocytopenia being a notable concern in some cases[3][5].
• Efficacy Outcomes: Abrocitinib has shown significant improvements in EASI scores and IGA responses, indicating its effectiveness in managing AD symptoms[5].

Market Size and Growth Projections

The market size for abrocitinib is expected to grow substantially over the next few years.

• US Market: The US market is a significant segment, with analysts projecting considerable growth driven by the drug's efficacy and the large patient population with moderate-to-severe AD[1][3].
• Global Market: The global market for abrocitinib is also expected to expand, with forecasts indicating strong sales growth across the seven major markets[1].

Key Highlights and Competitive Positioning

Abrocitinib's competitive positioning is strengthened by several key factors:

• Forecasted Sales: The drug's sales are forecasted to be significant, with detailed market forecasts available until 2032[1].
• Clinical Advancements: Abrocitinib's clinical trial advancements and regulatory milestones position it favorably against other emerging therapies for AD[1].
• Cost-Effectiveness: The drug's cost-effectiveness compared to other treatments makes it an attractive option for healthcare systems and patients[2][4].

Conclusion

Abrocitinib is poised for remarkable market expansion and financial growth, driven by its efficacy, cost-effectiveness, and strong competitive positioning. As the demand for effective atopic dermatitis treatments continues to rise, abrocitinib is well-positioned to capture a significant share of the market.

Key Takeaways

• Market Expansion: Abrocitinib is expected to see significant market expansion in the US, EU4, the UK, and Japan.
• Cost-Effectiveness: The drug is cost-effective compared to other JAK inhibitors and biological therapies.
• Efficacy: Abrocitinib has demonstrated strong efficacy in clinical trials, achieving high response rates in EASI scores and IGA responses.
• Regulatory Approvals: The drug has received regulatory approvals, including from the FDA.
• Safety: Common adverse events include nasopharyngitis, nausea, and headache, with rare serious adverse events.

FAQs

Q: What is abrocitinib prescribed for? A: Abrocitinib, marketed as Cibinqo, is prescribed for the treatment of moderate-to-severe atopic dermatitis (eczema).

Q: How does abrocitinib compare to other treatments in terms of cost-effectiveness? A: Studies have shown that abrocitinib is cost-effective compared to other JAK inhibitors and biological therapies, offering significant cost savings and QALYs gained[2][4].

Q: What are the common adverse events associated with abrocitinib? A: Common adverse events include nasopharyngitis, nausea, and headache. Serious adverse events, such as thrombocytopenia, are relatively rare[3][5].

Q: What is the projected peak sales for abrocitinib? A: Analysts project that Cibinqo could generate up to $3 billion in peak sales, with more conservative estimates suggesting $2 billion by 2027[3].

Q: Has abrocitinib received regulatory approvals? A: Yes, abrocitinib has received approval from regulatory bodies such as the FDA[3].

Sources

1. OpenPR: Abrocitinib Poised for Remarkable Market Expansion of Atopic Dermatitis by 2032
2. PubMed: Cost-Effectiveness Analysis of Abrocitinib Compared with Other JAK Inhibitors and Biological Therapies
3. BioSpace: Another Atopic Dermatitis Drug Hits the Market as FDA Okays Pfizer's Cibinqo
4. NCBI Bookshelf: Pharmacoeconomic Review - Abrocitinib (Cibinqo)
5. JAMA Dermatology: Efficacy and Safety of Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis