FORADIL Drug Patent Profile
✉ Email this page to a colleague
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 |
University of Tennessee Graduate School of Medicine | 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 | |
Poland | 342825 | ⤷ Try a Trial | |
Japan | 2013075909 | AEROSOL COMPOSITION COMPRISING FORMOTEROL | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 9945986 | ⤷ Try a Trial | |
Russian Federation | 2002116251 | ⤷ 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 | 21C1020 | France | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210 |
2435024 | C02435024/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: BUDESONID, GLYCOPYRRONIUM UND FORMOTEROL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68388 24.11.2021 |
2435024 | 15/2021 | Austria | ⤷ Try a Trial | PRODUCT NAME: FORMOTEROLFUMARAT-DIHYDRAT / GLYCOPYRRONIUMBROMID / BUDESONID; REGISTRATION NO/DATE: EU/1/20/1498 (MITTEILUNG) 20201210 |
2435025 | 2019026 | Norway | ⤷ Try a Trial | PRODUCT NAME: KOMBINASJON AV GLYKOPYRROLAT (INKLUDERT EVENTUELLE FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV) OG FORMOTEROL (INNBEFATTENDE HVILKE SOM HELST FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV); REG. NO/DATE: EU/1/18/1339 20190104 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |