ATOGEPANT - Generic Drug Details
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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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Atogepant has one hundred and two patent family members in forty-five countries.
One supplier is listed for this compound.
Summary for ATOGEPANT
International Patents: | 102 |
US Patents: | 4 |
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
Generic Entry Date for ATOGEPANT*:
Constraining patent/regulatory exclusivity:
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 |
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
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 | 215206-002 | Sep 28, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Abbvie | QULIPTA | atogepant | TABLET;ORAL | 215206-002 | Sep 28, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Abbvie | QULIPTA | atogepant | TABLET;ORAL | 215206-002 | Sep 28, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Abbvie | QULIPTA | atogepant | TABLET;ORAL | 215206-003 | Sep 28, 2021 | RX | Yes | Yes | ⤷ 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 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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ATOGEPANT
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Slovenia | 2821407 | ⤷ Sign Up | |
South Korea | 101537877 | ⤷ Sign Up | |
Croatia | P20161641 | ⤷ Sign Up | |
Japan | 2019108366 | CGRP活性化合物の錠剤製剤 (TABLET FORMULATION FOR CGRP ACTIVE COMPOUNDS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ATOGEPANT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2638042 | 34/2023 | Austria | ⤷ Sign Up | PRODUCT NAME: ATOGEPANT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 (MITTEILUNG) 20230814 |
2638042 | CR 2023 00033 | Denmark | ⤷ Sign Up | PRODUCT NAME: ATOGEPANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1750 20230814 |
2638042 | LUC00321 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: ATOGEPANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1750 20230814 |
2638042 | 122023000058 | Germany | ⤷ Sign Up | PRODUCT NAME: ATOGEPANT ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 20230811 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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