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. Thirteen 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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Questions you can ask:
- What is the 5 year forecast for PERFOROMIST?
- What are the global sales for PERFOROMIST?
- What is Average Wholesale Price for PERFOROMIST?
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: | 3,313 |
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 |
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 |
>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 |
---|---|---|---|
Japan | 6214925 | ⤷ Sign Up | |
European Patent Office | 1381346 | COMPOSITIONS PHARMACEUTICALES COMPRENANT FORMOTEROL (PHARMACEUTICAL COMPOSITIONS CONTAINING FORMOTEROL) | ⤷ Sign Up |
Slovenia | 1381346 | ⤷ 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 | 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 |