PERFOROMIST Drug Patent Profile
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Which patents cover Perforomist, and what generic alternatives are available?
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. Nine 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.
Summary for PERFOROMIST
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 87 |
Clinical Trials: | 6 |
Patent Applications: | 3,242 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for PERFOROMIST |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PERFOROMIST |
What excipients (inactive ingredients) are in PERFOROMIST? | PERFOROMIST excipients list |
DailyMed Link: | PERFOROMIST at DailyMed |
Recent Clinical Trials for PERFOROMIST
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Mylan Inc. | Phase 3 |
Theravance Biopharma | Phase 3 |
Chiesi Farmaceutici S.p.A. | Phase 2 |
Pharmacology for PERFOROMIST
Drug Class | beta2-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta2-Agonists |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
>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 |
---|---|---|---|
Taiwan | I359675 | ⤷ Sign Up | |
Japan | 6214925 | ⤷ Sign Up | |
Portugal | 1381346 | ⤷ Sign Up | |
European Patent Office | 1381346 | COMPOSITIONS PHARMACEUTICALES COMPRENANT FORMOTEROL (PHARMACEUTICAL COMPOSITIONS CONTAINING FORMOTEROL) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PERFOROMIST
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2435024 | 2021019 | Norway | ⤷ Sign Up | PRODUCT NAME: KOMBINASJON AV FORMOTEROL; REG. NO/DATE: EU/1/20/1498 20201216 |
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 |
2435025 | 19C1040 | France | ⤷ Sign Up | PRODUCT NAME: COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET DE FORMOTEROL (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); NAT. REGISTRATION NO/DATE: EU/1/18/1339 20181220; FIRST REGISTRATION: - EU/1/18/1339 20181220 |
2435024 | 15/2021 | Austria | ⤷ Sign Up | PRODUCT NAME: FORMOTEROLFUMARAT-DIHYDRAT / GLYCOPYRRONIUMBROMID / BUDESONID; REGISTRATION NO/DATE: EU/1/20/1498 (MITTEILUNG) 20201210 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |