qulipta Drug Patent Profile
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When do Qulipta patents expire, and what generic alternatives are available?
Qulipta is a drug marketed by Abbvie and is included in one NDA. There are four patents protecting this drug.
This drug has one hundred and two 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
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Summary for qulipta
| International Patents: | 102 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 11 |
| Clinical Trials: | 7 |
| Patent Applications: | 25 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for qulipta
*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 |
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 four US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of qulipta is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting qulipta
Tablet formulation for CGRP active compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Piperidinone carboxamide azaindane CGRP receptor antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS
Piperidinone carboxamide azaindane CGRP receptor antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS
Process for making CGRP receptor antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting qulipta
PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS
Exclusivity Expiration: ⤷ Sign Up
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Abbvie | QULIPTA | atogepant | TABLET;ORAL | 215206-003 | Sep 28, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abbvie | QULIPTA | atogepant | TABLET;ORAL | 215206-002 | Sep 28, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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
Patent: 15214502
Patent: Tablet formulation for CGRP-active compounds
Estimated Expiration: ⤷ Sign Up
Patent: 19226239
Patent: Tablet formulation for CGRP-active compounds
Estimated Expiration: ⤷ Sign Up
Patent: 21245229
Patent: Tablet formulation for CGRP-active compounds
Estimated Expiration: ⤷ Sign Up
Patent: 23258317
Patent: Tablet formulation for CGRP-active compounds
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2016017999
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 37315
Patent: FORMULATION DE COMPRIME POUR COMPOSES ACTIFS VIS-A-VIS DU CGRP (TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Patent: 37942
Patent: COMBINAISONS A DOSE FIXE DE COMPOSES ANTIVIRAUX (FIXED-DOSE COMBINATIONS OF ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 5939715
Patent: 抗病毒化合物的固定剂量组合 (FIXED-DOSE COMBINATIONS OF ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Patent: 5960397
Patent: CGRP-活性化合物的片剂制剂 (Tablet formulation for CGRP-active compounds)
Estimated Expiration: ⤷ Sign Up
Patent: 2022818
Patent: CGRP-活性化合物的片剂制剂 (Tablet formulation for CGRP-active compounds)
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 02188
Patent: NOUVEAUX SYSTÈMES DE DÉSINTÉGRATION DE FORMES DOSIFIÉES PHARMACEUTIQUES (NOVEL DISINTEGRATION SYSTEMS FOR PHARMACEUTICAL DOSAGE FORMS)
Estimated Expiration: ⤷ Sign Up
Patent: 02210
Patent: COMPOSITION PHARMACEUTIQUE D'INHIBITEURS SÉLECTIFS DE LA NS3/4A DU HCV (PHARMACEUTICAL COMPOSITION OF SELECTIVE HCV NS3/4A INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Patent: 02211
Patent: COMBINAISONS À DOSE FIXE DE COMPOSÉS ANTIVIRAUX (FIXED-DOSE COMBINATIONS OF ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Patent: 02564
Patent: FORMULATION DE COMPRIMÉ POUR COMPOSÉS ACTIFS VIS-À-VIS DU CGRP (TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Patent: 37412
Patent: FORMULATIONS À DISPERSION SOLIDE DE COMPOSÉS ANTIVIRAUX (SOLID DISPERSION FORMULATIONS OF ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 32218
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 6828
Patent: פורמולציית טבליה לחומרים הפועלים על cgrp (Tablet formulation for cgrp-active compounds)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 91669
Estimated Expiration: ⤷ Sign Up
Patent: 66490
Estimated Expiration: ⤷ Sign Up
Patent: 17505306
Patent: ＣＧＲＰ活性化合物の錠剤製剤
Estimated Expiration: ⤷ Sign Up
Patent: 19108366
Patent: ＣＧＲＰ活性化合物の錠剤製剤 (TABLET FORMULATION FOR CGRP ACTIVE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 16010169
Patent: FORMULACION DE TABLETA PARA COMPUESTOS ACTIVOS DE PEPTIDO RELACIONADO CON EL GEN DE CALCITONINA. (TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS.)
Estimated Expiration: ⤷ Sign Up
Patent: 21006790
Patent: FORMULACION DE TABLETA PARA COMPUESTOS ACTIVOS DE PEPTIDO RELACIONADO CON EL GEN DE CALCITONINA. (TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS.)
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 96578
Patent: ТЕХНОЛОГИЯ ПРИГОТОВЛЕНИЯ ТАБЛЕТОК ДЛЯ CGRP-АКТИВНЫХ СОЕДИНЕНИЙ (TABLETS PREPARATION TECHNOLOGY FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Patent: 19123406
Patent: ТЕХНОЛОГИЯ ПРИГОТОВЛЕНИЯ ТАБЛЕТОК ДЛЯ CGRP-АКТИВНЫХ СОЕДИНЕНИЙ
Estimated Expiration: ⤷ Sign Up
Saudi Arabia
Patent: 6371613
Patent: CGRP صيغة قرص لمركبات نشطة تجاه (Tablet Formulation for CGRP-Active Compounds)
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2448369
Estimated Expiration: ⤷ Sign Up
Patent: 160113296
Patent: CGRP-활성 화합물에 대한 정제 제제 (TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Patent: 220136460
Patent: CGRP-활성 화합물에 대한 정제 제제 (CGRP- TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Patent: 230107902
Patent: CGRP-활성 화합물에 대한 정제 제제 (CGRP- TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Portugal | 2821407 | ⤷ Sign Up | |
| China | 103328478 | Piperidinone carboxamide azaindane cgrp receptor antagonists | ⤷ Sign Up |
| Israel | 225978 | תולדות n-(5-פניל-2-אוקסו-פיפרידינ-3-איל)-{7,6-דיהידרו-h5-ציקלופנטא[b]פירידין-3-קרבוקסאמיד ושימושן להכנת תרופה לטיפול בכאבי ראש (N-(5-phenyl-2-oxo-piperidin-3-yl)-{6,7-dihydro-5h-cyclopenta[b]pyridine}-3-carboxamide derivatives and their use for the manufacture of medicaments for treating headache) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for qulipta
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2638042 | 122023000058 | Germany | ⤷ Sign Up | PRODUCT NAME: ATOGEPANT ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 20230811 |
| 2638042 | PA2023532 | Lithuania | ⤷ Sign Up | PRODUCT NAME: ATOGEPANTAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1750 20230811 |
| 2638042 | CR 2023 00033 | Denmark | ⤷ Sign Up | PRODUCT NAME: ATOGEPANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1750 20230814 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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