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. Twelve 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for FORADIL?
- What are the global sales for FORADIL?
- What is Average Wholesale Price for FORADIL?
Summary for FORADIL
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 123 |
Clinical Trials: | 33 |
Patent Applications: | 4,044 |
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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | FORADIL CERTIHALER | formoterol fumarate | POWDER;INHALATION | 021592-001 | Dec 15, 2006 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | FORADIL | formoterol fumarate | POWDER;INHALATION | 020831-001 | Feb 16, 2001 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
European Patent Office | 1061979 | INHALATEUR A POUDRE (POWDER INHALER) | ⤷ Sign Up |
Spain | 2232119 | ⤷ Sign Up | |
Canada | 2389349 | UTILISATION DE COMPOSES ORGANIQUES DANS LE TRAITEMENT D'UNE MALADIE (AEROSOL COMPOSITION COMPRISING FORMOTEROL) | ⤷ Sign Up |
European Patent Office | 1233757 | ⤷ Sign Up | |
Japan | 4082864 | ⤷ Sign Up | |
European Patent Office | 3050558 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FORADIL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2435025 | PA2019014,C2435025 | Lithuania | ⤷ Sign Up | PRODUCT NAME: GLIKOPIRONIO BROMIDAS/FORMOTEROLIS; REGISTRATION NO/DATE: EU/1/18/1339 20181218 |
2435024 | 122021000026 | Germany | ⤷ Sign Up | PRODUCT NAME: GLYCOPYRROLAT MIT FORMOTEROL MIT BUDESONID, ODER SALZE, ESTER, SOLVATE, ENANTIOMERE UND MISCHUNGEN VON ENANTIOMEREN DERSELBEN; REGISTRATION NO/DATE: EU/1/20/1498 20201209 |
2435025 | 2019026 | Norway | ⤷ Sign Up | 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 |
2435025 | 36/2019 | Austria | ⤷ Sign Up | PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220 |
2435024 | 21C1020 | France | ⤷ Sign Up | 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 | 2190014-7 | Sweden | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |