Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
McKinsey
Express Scripts
Baxter
Merck

Last Updated: June 10, 2023

PERFOROMIST Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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. Seven 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.

  Try a Trial

Drug patent expirations by year for PERFOROMIST
Drug Prices for PERFOROMIST

See drug prices for PERFOROMIST

Recent Clinical Trials for PERFOROMIST

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

SponsorPhase
Mylan Inc.Phase 3
Theravance BiopharmaPhase 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 ⤷  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 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 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for PERFOROMIST

When does loss-of-exclusivity occur for PERFOROMIST?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

European Patent Office

Patent: 60035
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 59675
Estimated Expiration: ⤷  Try a Trial

Patent: 0507830
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country Patent Number Title Estimated Expiration
Japan 2013155208 AEROSOL COMPOSITION CONTAINING FORMOTEROL FOR DELIVERY TO LUNG THROUGH FOGGING ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 02083079 ⤷  Try a Trial
European Patent Office 1660035 COMPOSITIONS LIQUIDES COMPRENANT DU FORMOTEROL (LIQUID COMPOSITIONS COMPRISING FORMOTEROL) ⤷  Try a Trial
Japan 2009046490 AEROSOL COMPOSITION CONTAINING FORMOTEROL FOR DELIVERY TO LUNGS VIA NEBULIZATION ⤷  Try a Trial
Australia 2002244211 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PERFOROMIST

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435025 36/2019 Austria ⤷  Try a Trial PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220
2435024 2021C/518 Belgium ⤷  Try a Trial PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210
2435025 PA2019014,C2435025 Lithuania ⤷  Try a Trial PRODUCT NAME: GLIKOPIRONIO BROMIDAS/FORMOTEROLIS; REGISTRATION NO/DATE: EU/1/18/1339 20181218
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
2435025 300995 Netherlands ⤷  Try a Trial PRODUCT NAME: COMBINATIE VAN GLYCOPYRRONIUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER GLYCOPYRRONIUYM BROMIDE, EN FORMOTEROL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER FORMOTEROL FUMARAAT DIHYDRAAT; REGISTRATION NO/DATE: EU/ 1/18/1339 20181220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Medtronic
Merck
Harvard Business School
McKinsey
AstraZeneca

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.