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. Thirteen 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.
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Questions you can ask:
- What is the 5 year forecast for FORADIL?
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Summary for FORADIL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 123 |
| Clinical Trials: | 33 |
| Patent Applications: | 4,449 |
| 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 |
|---|---|
| Food and Drug Administration (FDA) | Phase 1 |
| University of Florida | 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 |
|---|---|---|---|
| Germany | 29923581 | ⤷ Sign Up | |
| Hungary | 0203728 | ⤷ Sign Up | |
| European Patent Office | 2011484 | ⤷ 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 | C201930043 | Spain | ⤷ Sign Up | PRODUCT NAME: UNA COMBINACION DE GLICOPIRROLATO (INCLUYENDO CUALQUIERA DE SUS SALES, ESTERES O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES) Y FORMOTEROL (INCLUYENDO CUALQUIERA DE SUS SALES, ESTERES O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES).; NATIONAL AUTHORISATION NUMBER: EU/1/18/1339; DATE OF AUTHORISATION: 20181218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1339; DATE OF FIRST AUTHORISATION IN EEA: 20181218 |
| 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 |
| 2435024 | C02435024/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: BUDESONID, GLYCOPYRRONIUM UND FORMOTEROL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68388 24.11.2021 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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