FORADIL Drug Patent Profile
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Which patents cover Foradil, and when can generic versions of Foradil launch?
Foradil is a drug marketed by Novartis and is included in two NDAs.
The generic ingredient in FORADIL is formoterol fumarate. There are nineteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the formoterol fumarate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Foradil
A generic version of FORADIL was approved as formoterol fumarate by TEVA PHARMS USA INC on June 22nd, 2021.
Summary for FORADIL
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 123 |
Clinical Trials: | 33 |
Patent Applications: | 4,063 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in FORADIL? | FORADIL excipients list |
DailyMed Link: | FORADIL at DailyMed |
Recent Clinical Trials for FORADIL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Florida | Phase 1 |
Food and Drug Administration (FDA) | Phase 1 |
Mylan Specialty L.P. | N/A |
Anatomical Therapeutic Chemical (ATC) Classes for FORADIL
US Patents and Regulatory Information for FORADIL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | FORADIL | formoterol fumarate | POWDER;INHALATION | 020831-001 | Feb 16, 2001 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Novartis | FORADIL CERTIHALER | formoterol fumarate | POWDER;INHALATION | 021592-001 | Dec 15, 2006 | DISCN | No | No | ⤷ 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 |
Expired US Patents for FORADIL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | FORADIL | formoterol fumarate | POWDER;INHALATION | 020831-001 | Feb 16, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | FORADIL | formoterol fumarate | POWDER;INHALATION | 020831-001 | Feb 16, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FORADIL
See the table below for patents covering FORADIL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2837401 | ⤷ Try a Trial | |
Colombia | 5080779 | INHALADORES DE POLVO SECO DE UNA SOLA DOSIS EN DONDE EL MEDICAMENTO SE ALMACENA EN UNA CAPSULA ANTES DE LIBERARSE | ⤷ Try a Trial |
Czech Republic | 20021850 | ⤷ Try a Trial | |
Canada | 2389349 | UTILISATION DE COMPOSES ORGANIQUES DANS LE TRAITEMENT D'UNE MALADIE (AEROSOL COMPOSITION COMPRISING FORMOTEROL) | ⤷ Try a Trial |
European Patent Office | 1061979 | INHALATEUR A POUDRE (POWDER INHALER) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FORADIL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2435024 | 2021019 | Norway | ⤷ Try a Trial | PRODUCT NAME: KOMBINASJON AV FORMOTEROL; REG. NO/DATE: EU/1/20/1498 20201216 |
2435024 | 15/2021 | Austria | ⤷ Try a Trial | PRODUCT NAME: FORMOTEROLFUMARAT-DIHYDRAT / GLYCOPYRRONIUMBROMID / BUDESONID; REGISTRATION NO/DATE: EU/1/20/1498 (MITTEILUNG) 20201210 |
2435025 | 132019000000087 | Italy | ⤷ Try a Trial | PRODUCT NAME: UNA COMBINAZIONE DI GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, ENANTIOMERI O ALTRI DERIVATI FARMACEUTICAMENTE ACCETTABILI) E FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, ENANTIOMERI O ALTRI DERIVATI FARMACEUTICAMENTE ACCETTABILI)(BEVESPI AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1339, 20181220 |
2435025 | PA2019014,C2435025 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: GLIKOPIRONIO BROMIDAS/FORMOTEROLIS; REGISTRATION NO/DATE: EU/1/18/1339 20181218 |
2435025 | CA 2019 00032 | Denmark | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION AF GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF, OG FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF; REG. NO/DATE: EU/1/18/1339 20181220 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |