About atogepant
Atogepant manufacturers are currently limited to the originator, AbbVie, which sells it as Qulipta in the US and as Aquipta in the EU. Atogepant is an oral CGRP receptor antagonist (a "gepant") taken once daily to prevent migraine. It is approved for both episodic and chronic migraine in adults. No generic is approved. Pharmaceutical companies can prepare atogepant tablet and API dossiers for launch after patent expiry.
Atogepant key facts
|
Property |
Atogepant |
|---|---|
|
INN |
Atogepant |
|
Molecular formula / weight |
C29H23F6N5O3 / 603.5 g/mol |
|
ATC code |
N02CD07 |
|
Drug class |
Calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) |
|
Brand names |
Qulipta (US); Aquipta (EU) |
|
Originator |
Discovered by Merck; developed by Allergan, now AbbVie |
|
Dosage form and strengths |
Tablets 10, 30 and 60 mg (US) |
|
Dose |
60 mg once daily for most patients |
|
Indication |
Preventive treatment of episodic and chronic migraine in adults |
|
First approval |
US FDA, September 2021 (episodic migraine) |
|
Other approvals |
US chronic migraine, 2023; EU, 2023 |
|
Generic status |
No generic approved |
|
Patent status |
US compound and formulation patents in force |
Atogepant manufacturers and licensing history
Merck discovered atogepant, and Allergan licensed it in 2015. AbbVie acquired Allergan in 2020 and completed development. The FDA approved Qulipta in September 2021 for episodic migraine, as the first oral CGRP antagonist approved only for prevention.
The FDA extended approval to chronic migraine in 2023, and the EU approved it as Aquipta in 2023. Atogepant competes with other gepants, such as rimegepant, and with injectable CGRP antibodies.
No generic atogepant is approved. Generic developers are preparing API and tablet dossiers ahead of patent expiry. Buyers should confirm the API's crystal form, GMP status and freedom to operate before choosing a dossier partner.
Atogepant dosage forms and dossier types
Atogepant is approved as 10, 30 and 60 mg tablets in the US. Generic developers focus on the 60 mg tablet, the most used strength.
|
Form |
Strengths |
Typical dossier |
Notes |
|---|---|---|---|
|
Atogepant tablets |
10, 30, 60 mg |
Future US ANDA; EU CTD |
Reference Qulipta / Aquipta |
|
Atogepant API |
Bulk |
US DMF; EU ASMF |
Crystal form is critical |
|
Target market |
Dossier format |
Key requirement |
|---|---|---|
|
United States |
Future ANDA |
Patent certification; NCE exclusivity ended 2026 |
|
European Union |
Future EU CTD |
Data protection and SPC expiry |
|
Other markets |
CTD |
Check local patents |
Atogepant regulatory and patent status
The FDA approved atogepant in September 2021 for episodic migraine and in 2023 for chronic migraine. The EU approved it in 2023. Atogepant is protected by compound and formulation patents, and no generic is approved. Check the FDA Orange Book, any paragraph IV filings and EU data protection before planning development.
Atogepant mechanism of action and therapeutic use
Atogepant blocks the receptor for calcitonin gene-related peptide (CGRP), a molecule that drives migraine pain and inflammation. Taken every day, it reduces the number of migraine days. It is used for preventive treatment of episodic and chronic migraine in adults, usually at 60 mg once daily.
Atogepant licensing and sourcing
Atogepant is currently available only from AbbVie. Companies interested in this molecule usually prepare future generic dossiers or API supply. Current offers and supplier contacts are listed among the atogepant manufacturers on Pipelinepharma.
Frequently asked questions about atogepant
Who manufactures atogepant? AbbVie is the only manufacturer and sells atogepant as Qulipta in the US and Aquipta in the EU.
Is there a generic version of atogepant? No. No generic atogepant is approved, and patents are in force.
What is atogepant used for? Atogepant is used to prevent episodic and chronic migraine in adults.
What forms and strengths of atogepant are available? Atogepant is available as 10, 30 and 60 mg tablets in the US.
How is atogepant different from triptans? Triptans treat migraine attacks once they start. Atogepant is taken every day to prevent migraines.
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