Fezolinetant - Generic Drug Details
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What are the generic drug sources for fezolinetant and what is the scope of patent protection?
Fezolinetant
is the generic ingredient in one branded drug marketed by Astellas and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Fezolinetant has sixty patent family members in twenty-six countries.
One supplier is listed for this compound.
Summary for fezolinetant
| International Patents: | 60 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 32 |
| Clinical Trials: | 14 |
| Patent Applications: | 49 |
| What excipients (inactive ingredients) are in fezolinetant? | fezolinetant excipients list |
| DailyMed Link: | fezolinetant at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for fezolinetant
Generic Entry Date for fezolinetant*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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 fezolinetant
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Astellas Pharma Inc | Phase 2 |
| Astellas Pharma China, Inc. | Phase 1 |
| Astellas Pharma China, Inc. | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for fezolinetant
US Patents and Regulatory Information for fezolinetant
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astellas | VEOZAH | fezolinetant | TABLET;ORAL | 216578-001 | May 12, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Astellas | VEOZAH | fezolinetant | TABLET;ORAL | 216578-001 | May 12, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Astellas | VEOZAH | fezolinetant | TABLET;ORAL | 216578-001 | May 12, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Astellas | VEOZAH | fezolinetant | TABLET;ORAL | 216578-001 | May 12, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Astellas | VEOZAH | fezolinetant | TABLET;ORAL | 216578-001 | May 12, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for fezolinetant
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Norway | 2948455 | ⤷ Try a Trial | |
| Singapore | 11201508005X | NOVEL N-ACYL-(3-SUBSTITUTED)-(8-SUBSTITUTED)-5,6-DIHYDRO- [1,2,4]TRIAZOLO[4,3-a]PYRAZINES AS SELECTIVE NK-3 RECEPTOR ANTAGONISTS, PHARMACEUTICAL COMPOSITION, METHODS FOR USE IN NK-3 RECEPTOR-MEDIATED DISORDERS | ⤷ Try a Trial |
| Croatia | P20171688 | ⤷ Try a Trial | |
| Japan | 2018118988 | 選択的ＮＫ−３受容体拮抗薬としての新規なＮ−アシル−（３位置換）−（８位置換）−５，６−ジヒドロ−［１，２，４］トリアゾロ［４，３−ａ］ピラジン、医薬組成物、ＮＫ−３受容体媒介性障害における使用方法 (N-ACYL-(3-SUBSTITUTED)-(8-SUBSTITUTED)-5,6-DIHYDRO- [1,2,4]TRIAZOLO[4,3-A]PYRAZINES AS SELECTIVE NK-3 RECEPTOR ANTAGONISTS, PHARMACEUTICAL COMPOSITION, METHODS FOR USE IN NK-3 RECEPTOR-MEDIATED DISORDERS) | ⤷ Try a Trial |
| Lithuania | 2552920 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2011121137 | ⤷ Try a Trial | |
| Mexico | 2015013711 | NOVEDOSAS N-ACIL-(3-SUSTITUIDAS)-(8-SUSTITUIDAS)-5,6-DIHIDRO-[1,2, 4]TRIAZOLO[4,3-A]PIRACINAS COMO ANTAGONISTAS SELECTICOS DE RECEPTOR DE NK-3, COMPOSICION FARMACEUTICA Y METODOS PARA SU USO EN TRASTORNOS MEDIADOS POR EL RECEPTOR DE NK-3. (NOVEL N-ACYL-(3-SUBSTITUTED)-(8-SUBSTITUTED)-5,6-DIHYDRO- [1,2,4]TRIAZOLO[4,3-a]PYRAZINES AS SELECTIVE NK-3 RECEPTOR ANTAGONISTS, PHARMACEUTICAL COMPOSITION, METHODS FOR USE IN NK-3 RECEPTOR-MEDIATED DISORDERS.) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
