ATOGEPANT - Generic Drug Details

What are the generic sources for atogepant and what is the scope of freedom to operate?

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

Atogepant has one hundred and fourteen patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for ATOGEPANT

International Patents:	114
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	18
Patent Applications:	55
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ATOGEPANT
What excipients (inactive ingredients) are in ATOGEPANT?	ATOGEPANT excipients list
DailyMed Link:	ATOGEPANT at DailyMed

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

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 ATOGEPANT

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

Sponsor	Phase
AbbVie	Phase 1
AbbVie	Phase 3
Allergan	Phase 4

See all ATOGEPANT clinical trials

Pharmacology for ATOGEPANT

Drug Class	Calcitonin Gene-related Peptide Receptor Antagonist
Mechanism of Action	Calcitonin Gene-related Peptide Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ATOGEPANT

N02CD	Calcitonin gene-related peptide (CGRP) antagonists
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

US Patents and Regulatory Information for ATOGEPANT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-001	Sep 28, 2021		RX	Yes	No
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-003	Sep 28, 2021		RX	Yes	Yes			Y	Y
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-003	Sep 28, 2021		RX	Yes	Yes
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-003	Sep 28, 2021		RX	Yes	Yes			Y	Y
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-001	Sep 28, 2021		RX	Yes	No			Y	Y

EU/EMA Drug Approvals for ATOGEPANT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH & Co. KG	Aquipta	atogepant	EMEA/H/C/005871 Aquipta is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month	Authorised	no	no	no	2023-08-11

International Patents for ATOGEPANT

Country	Patent Number	Title	Estimated Expiration
Spain	2604827
Hungary	S2300037
Australia	2021409718
Malaysia	165113	PIPERIDINONE CARBOXAMIDE AZAINDANE CGRP RECEPTOR ANTAGONISTS
Canada	3206184

Supplementary Protection Certificates for ATOGEPANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2638042	122023000058	Germany		PRODUCT NAME: ATOGEPANT ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 20230811
2638042	PA2023532	Lithuania		PRODUCT NAME: ATOGEPANTAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1750 20230811
2638042	CR 2023 00033	Denmark		PRODUCT NAME: ATOGEPANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1750 20230814
2638042	301248	Netherlands		PRODUCT NAME: ATOGEPANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1750 20230814
2638042	LUC00321	Luxembourg		PRODUCT NAME: ATOGEPANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1750 20230814

ATOGEPANT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Atogepant (Qulipta)

Introduction

Atogepant, marketed as Qulipta, is a significant player in the migraine treatment market, particularly in the preventive treatment of episodic migraine. Developed by AbbVie, this drug has been making waves with its efficacy and patient-centered approach. Here, we delve into the market dynamics and financial trajectory of atogepant.

Market Size and Growth

The global migraine drugs market is substantial and growing rapidly. As of 2023, the market size was estimated at USD 5.64 billion and is projected to grow at a Compound Annual Growth Rate (CAGR) of 11.9% from 2024 to 2030[3].

Approval and Regulatory Landscape

Atogepant has received significant regulatory approvals. It is one of the FDA-approved small-molecule CGRP antagonists, along with rimegepant (Nurtec) and others, marking a significant advancement in migraine treatment[3].

Clinical Efficacy

Atogepant has demonstrated strong clinical efficacy in reducing monthly migraine days (MMDs). The Phase 3 ELEVATE trial showed that patients on atogepant 60 mg once daily experienced a statistically significant reduction of 4.20 days in their mean MMDs compared to a 1.85 day reduction in the placebo arm[5].

Patient-Centered Approach

AbbVie has emphasized a patient-centered approach with atogepant, focusing on quality of life, daily functioning, and rapid relief. This approach was highlighted at the European Headache Congress, where AbbVie presented data showing improvements in function, quality of life, and disability across all trials[4].

Health Economics and Outcomes Research (HEOR)

The HEOR analysis for atogepant has been favorable. It showed a responder rate (RR) of 64.9% for atogepant, compared to 51.8% for rimegepant and 44.1% for placebo. The Cost Per Responder (CPR) against placebo was $15,069 for atogepant, significantly lower than $69,551 for rimegepant[4].

Cost-Effectiveness

The cost-effectiveness of atogepant is a critical factor in its market dynamics. While the drug is not considered cost-effective at its current price point compared to other treatments, aligning its pricing with the lowest-cost active comparator could make it more viable. The annual per-patient cost of atogepant is approximately $6,735, based on a price of $18.44 per tablet[1].

Market Competition

The migraine treatment market is highly competitive, with other CGRP antagonists like rimegepant (Nurtec) and galcanezumab competing for market share. However, atogepant's oral administration and once-daily dosing regimen offer a unique advantage over injectable CGRP monoclonal antibodies[3].

Financial Performance of AbbVie

AbbVie's financial performance in the neuroscience segment, which includes atogepant, has been robust. In Q2 2024, AbbVie reported a 14.7% growth in its neuroscience portfolio, with atogepant contributing $150 million to the revenue. This growth is part of AbbVie's broader success, driven by strong performances in immunology and oncology as well[2].

Revenue Contribution

Atogepant's revenue contribution, although smaller compared to other AbbVie products like Botox Therapeutic and Vraylar, is significant and growing. The drug's inclusion in AbbVie's neuroscience portfolio, which reached $2.162 billion in Q2 2024, indicates its potential for future growth[2].

Future Outlook

The future outlook for atogepant is promising. With ongoing research and presentations at key conferences like the American Academy of Neurology (AAN) Annual Meeting, AbbVie continues to build a strong case for atogepant's efficacy and cost-effectiveness. The drug's alignment with patient needs and its unique oral administration could further enhance its market position[5].

Key Takeaways

• Market Growth: The global migraine drugs market is growing at a CAGR of 11.9% from 2024 to 2030.
• Clinical Efficacy: Atogepant significantly reduces monthly migraine days and improves quality of life.
• Patient-Centered Approach: AbbVie focuses on quality of life, daily functioning, and rapid relief.
• Cost-Effectiveness: Atogepant needs to be priced competitively to ensure cost-effectiveness.
• Financial Performance: AbbVie's neuroscience segment, including atogepant, saw a 14.7% growth in Q2 2024.
• Future Outlook: Ongoing research and patient-centered approach position atogepant for future growth.

FAQs

What is atogepant, and how is it used?

Atogepant, marketed as Qulipta, is a small-molecule CGRP antagonist used for the preventive treatment of episodic migraine. It is administered orally once daily.

How effective is atogepant in reducing migraine days?

Atogepant has been shown to reduce monthly migraine days significantly. In the Phase 3 ELEVATE trial, patients on atogepant 60 mg once daily experienced a reduction of 4.20 days in their mean MMDs[5].

What is the cost of atogepant, and is it cost-effective?

The annual per-patient cost of atogepant is approximately $6,735. While it is not currently considered cost-effective at this price, aligning its pricing with the lowest-cost active comparator could improve its cost-effectiveness[1].

How does atogepant compare to other CGRP antagonists?

Atogepant offers a unique advantage with its oral administration and once-daily dosing regimen compared to injectable CGRP monoclonal antibodies. Its responder rate and cost per responder are also favorable compared to some competitors[4].

What is the future outlook for atogepant in the migraine treatment market?

The future outlook for atogepant is promising, with ongoing research, a patient-centered approach, and strong financial performance in AbbVie's neuroscience segment positioning it for continued growth[2][5].

How does AbbVie's overall financial performance impact atogepant's market dynamics?

AbbVie's robust financial performance, particularly in the neuroscience segment, provides a strong foundation for atogepant's market presence and future growth. The company's overall revenue growth and strategic investments support the drug's development and commercialization[2].

References

1. Pharmacoeconomic Review - Atogepant (Qulipta) - NCBI Bookshelf
2. AbbVie's Q2 2024 Financial Highlights: Growth in Immunology, Oncology, and Neuroscience
3. Migraine Drugs Market Size, Share & Trends Report, 2030
4. AbbVie showcases atagogepant impact on migraine at EHC
5. AbbVie Announces Late-Breaking Results from Phase 3 Trial Evaluating Atogepant (QULIPTA) for the Preventive Treatment of Episodic Migraine