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Last Updated: November 2, 2024

PERFOROMIST Drug Patent Profile


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When do Perforomist patents expire, and when can generic versions of Perforomist launch?

Perforomist is a drug marketed by Mylan Speclt and is included in one NDA.

The generic ingredient in PERFOROMIST 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 Perforomist

A generic version of PERFOROMIST was approved as formoterol fumarate by TEVA PHARMS USA INC on June 22nd, 2021.

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Drug patent expirations by year for PERFOROMIST
Drug Prices for PERFOROMIST

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Recent Clinical Trials for PERFOROMIST

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Theravance BiopharmaPhase 3
Mylan Inc.Phase 3
Chiesi Farmaceutici S.p.A.Phase 2

See all PERFOROMIST clinical trials

Pharmacology for PERFOROMIST
Paragraph IV (Patent) Challenges for PERFOROMIST
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PERFOROMIST Inhalation Solution formoterol fumarate 0.02 mg/2 mL 022007 1 2009-01-21

US Patents and Regulatory Information for PERFOROMIST

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 AN RX Yes Yes ⤷  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 PERFOROMIST

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 ⤷  Sign Up ⤷  Sign Up
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 ⤷  Sign Up ⤷  Sign Up
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 ⤷  Sign Up ⤷  Sign Up
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 ⤷  Sign Up ⤷  Sign Up
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 ⤷  Sign Up ⤷  Sign Up
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for PERFOROMIST

See the table below for patents covering PERFOROMIST around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 02083079 ⤷  Sign Up
European Patent Office 1660035 COMPOSITIONS LIQUIDES COMPRENANT DU FORMOTEROL (LIQUID COMPOSITIONS COMPRISING FORMOTEROL) ⤷  Sign Up
Japan 2013155208 AEROSOL COMPOSITION CONTAINING FORMOTEROL FOR DELIVERY TO LUNG THROUGH FOGGING ⤷  Sign Up
Japan 6214925 ⤷  Sign Up
Slovenia 1381346 ⤷  Sign Up
Japan 2009046490 AEROSOL COMPOSITION CONTAINING FORMOTEROL FOR DELIVERY TO LUNGS VIA NEBULIZATION ⤷  Sign Up
Canada 2438544 COMPOSITIONS BRONCHODILATATRICES ET METHODES ASSOCIEES (AEROSOL COMPOSITIONS CONTAINING FORMOTEROL FOR DELIVERY TO THE LUNGS VIA NEBULIZATION) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PERFOROMIST

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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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