PERFOROMIST Drug Patent Profile
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When do Perforomist patents expire, 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 | ⤷ 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
See the table below for patents covering PERFOROMIST around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2004532217 | ⤷ Try a Trial | |
European Patent Office | 1660035 | COMPOSITIONS LIQUIDES COMPRENANT DU FORMOTEROL (LIQUID COMPOSITIONS COMPRISING FORMOTEROL) | ⤷ Try a Trial |
Taiwan | I359675 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 02083079 | ⤷ Try a Trial | |
Spain | 2554476 | ⤷ 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 | LUC00124 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220 |
2435025 | PA2019014,C2435025 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: GLIKOPIRONIO BROMIDAS/FORMOTEROLIS; REGISTRATION NO/DATE: EU/1/18/1339 20181218 |
2435024 | CA 2021 00014 | Denmark | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION AF FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, OG BUDESONID, HERUNDER...; REG. NO/DATE: EU/1/20/1498 20201210 |
2435025 | 2019C/532 | Belgium | ⤷ Try a Trial | PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI) ET DE FORMOTEROL (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220 |
2435025 | 132019000000087 | Italy | ⤷ Try a Trial | PRODUCT NAME: UNA COMBINAZIONE DI GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, ENANTIOMERI O ALTRI DERIVATI FARMACEUTICAMENTE ACCETTABILI) E FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, ENANTIOMERI O ALTRI DERIVATI FARMACEUTICAMENTE ACCETTABILI)(BEVESPI AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1339, 20181220 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |