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QULIPTA Drug Patent Profile

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

Qulipta is a drug marketed by Abbvie and is included in one NDA. There are five patents protecting this drug.

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

The generic ingredient in QULIPTA is atogepant. One supplier is listed for this compound. Additional details are available on the atogepant profile page.

DrugPatentWatch^® Generic Entry Outlook for Qulipta

Qulipta will be eligible for patent challenges on September 28, 2025. 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 January 30, 2035. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for QULIPTA

International Patents:	114
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	7
Patent Applications:	29
Drug Prices:	Drug price information for QULIPTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QULIPTA
What excipients (inactive ingredients) are in QULIPTA?	QULIPTA excipients list
DailyMed Link:	QULIPTA at DailyMed

See drug prices for QULIPTA

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

Constraining patent/regulatory exclusivity:

10,117,836

NDA:

215206

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 QULIPTA

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

Sponsor	Phase
AbbVie	Phase 1
AbbVie	Phase 3
Allergan	Phase 4

See all QULIPTA clinical trials

Pharmacology for QULIPTA

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

US Patents and Regulatory Information for QULIPTA

QULIPTA is protected by five US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,117,836.

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
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-001	Sep 28, 2021		RX	Yes	No	9,499,545		Y	Y
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-003	Sep 28, 2021		RX	Yes	Yes
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-002	Sep 28, 2021		RX	Yes	No	9,499,545		Y	Y
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-001	Sep 28, 2021		RX	Yes	No	10,117,836		Y
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-002	Sep 28, 2021		RX	Yes	No
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-002	Sep 28, 2021		RX	Yes	No	8,754,096		Y	Y

EU/EMA Drug Approvals for QULIPTA

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 QULIPTA

When does loss-of-exclusivity occur for QULIPTA?

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

Australia

Brazil

Canada

China

European Patent Office

Hong Kong

Israel

Japan

Mexico

Russian Federation

Saudi Arabia

South Korea

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 QULIPTA around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	S2300037
Montenegro	02552	ANTAGONISTI PIPERIDINON KARBOKSAMID AZAINDAN CGRP RECEPTORA (PIPERIDINONE CARBOXAMIDE AZAINDANE CGRP RECEPTOR ANTAGONISTS)
Australia	2021409718
Portugal	2821407
Canada	3206184
Malaysia	165113	PIPERIDINONE CARBOXAMIDE AZAINDANE CGRP RECEPTOR ANTAGONISTS

Supplementary Protection Certificates for QULIPTA

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
2638042	34/2023	Austria		PRODUCT NAME: ATOGEPANT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 (MITTEILUNG) 20230814

QULIPTA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Qulipta

Introduction to Qulipta

Qulipta, developed by AbbVie, is an oral calcitonin gene-related peptide (CGRP) inhibitor approved by the FDA in September 2021 for the preventive treatment of episodic migraine. This drug has been making significant strides in the migraine prevention market, posing a strong challenge to existing treatments.

Market Entry and Initial Uptake

Upon its launch, Qulipta faced competition from Biohaven's Nurtec ODT, which was the first-to-market CGRP inhibitor for both treating and preventing migraines. Despite being the second entrant, Qulipta quickly gained traction. A Spherix report indicated that three months post-launch, Qulipta's market share was one-third that of Nurtec ODT, with two out of five doctors actively prescribing Qulipta[1].

Physician Adoption and Future Projections

Physicians have shown optimism about Qulipta's future use. The Spherix report found that more than two-thirds of doctors, including current and anticipated users, expected to prescribe Qulipta within the next three months. By six months post-launch, Qulipta was projected to be close to its competitor, Nurtec ODT, in terms of both reported share and prescriber base in the prevention segment[1].

Competitive Landscape

Qulipta's robust uptake is expected to impact the market share of other CGRP antagonists, particularly the subcutaneous (SC) CGRP antagonists like Aimovig and Ajovy. Physicians prefer Qulipta due to its oral dosing profile, which addresses patients' needle phobia. This preference could result in a significant contraction of the SC CGRP antagonists' market share, with Aimovig likely to be the most affected[3].

Efficacy and Tolerability

Qulipta is highly competitive on its overall risk-benefit profile. Physicians agree that Qulipta provides at least equivalent efficacy to the SC CGRP antagonists and is more tolerable than Emgality. This strong efficacy and tolerability profile is a key driver for physician initiations and continued use of Qulipta[3].

Expansion to Chronic Migraine

The FDA approval of Qulipta for the preventive treatment of chronic migraine is expected to further boost its market presence. A survey by Spherix found that almost two-thirds of neurologists and more than 50% of primary care physicians are very willing to prescribe Qulipta for chronic migraine. This expansion could clear barriers to reimbursement and increase prescribing patterns[4].

Financial Performance

In its first year, Qulipta generated $114 million in global net revenues. By the first quarter of 2024, Qulipta's global net revenues had increased to $131 million, a 97.7% increase from the previous year. This significant growth indicates a strong financial trajectory for the drug[2][5].

Comparison with Competitors

While Qulipta is gaining ground, it still lags behind Nurtec ODT in terms of sales. In the fourth quarter of 2023, Nurtec ODT reported $211 million in sales, compared to Qulipta's $52 million. However, Qulipta's rapid growth suggests it is on track to close this gap[4].

Future Growth Potential

AbbVie is bullish on Qulipta's future, with the company guiding $200 million in sales for the year and anticipating commercial access to increase rapidly in the first half. The expansion of Qulipta's label to include chronic migraine prevention is expected to accelerate prescribing patterns and further drive sales growth[1].

Impact on AbbVie's Portfolio

Qulipta is part of AbbVie's comprehensive migraine portfolio, which also includes Ubrelvy for acute migraine treatment and Botox for migraine prevention. The success of Qulipta complements these other products, positioning AbbVie as a leader in the migraine treatment market. Ubrelvy, for instance, brought in $552 million in 2021, highlighting the potential for blockbuster sales across AbbVie's migraine drugs[1].

Key Takeaways

• Rapid Adoption: Qulipta has quickly gained traction among physicians, with significant projected growth in the next six months.
• Competitive Advantage: Qulipta's oral dosing profile and strong efficacy and tolerability are key factors in its market success.
• Expansion to Chronic Migraine: FDA approval for chronic migraine prevention is expected to further boost Qulipta's market presence.
• Financial Growth: Qulipta's sales have shown a significant increase, with a strong financial trajectory ahead.
• Market Impact: Qulipta's success is likely to impact the market share of other CGRP antagonists, particularly the subcutaneous ones.

FAQs

Q: What is Qulipta and how is it used? A: Qulipta is an oral CGRP inhibitor approved for the preventive treatment of episodic and chronic migraines.

Q: How has Qulipta performed in the market since its launch? A: Qulipta has shown robust uptake, with two out of five doctors actively prescribing it three months post-launch, and it is projected to be close to its competitor, Nurtec ODT, in market share within six months.

Q: What are the key advantages of Qulipta over other CGRP antagonists? A: Qulipta's oral dosing profile, strong efficacy, and better tolerability are its key advantages.

Q: How does Qulipta's financial performance compare to its competitors? A: While Qulipta lags behind Nurtec ODT in sales, it has shown significant growth and is expected to continue this trajectory.

Q: What is the potential impact of Qulipta's approval for chronic migraine prevention? A: The approval is expected to increase prescribing patterns, clear reimbursement barriers, and accelerate Qulipta's market growth.

Sources

1. FiercePharma: AbbVie's Qulipta gains ground with docs for migraine prevention, as pharma looks to pressure[1].
2. AbbVie Investors: AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results[2].
3. PR Newswire: Robust Uptake of AbbVie's Qulipta Turns Up the Pressure for Amgen, Eli Lilly, and Teva in the Prevention Segment of the Migraine Market[3].
4. FiercePharma: Most physicians very willing to use AbbVie's Qulipta in chronic migraine, survey[4].
5. PR Newswire: AbbVie Reports First-Quarter 2024 Financial Results[5].