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PERFOROMIST Drug Profile
» See Plans and Pricing
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. There are six patents protecting this drug and one Paragraph IV challenge.
This drug has sixteen patent family members in nine countries.
The generic ingredient in PERFOROMIST is formoterol fumarate. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the formoterol fumarate profile page.
US ANDA Litigation and Generic Entry Outlook for Perforomist
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
There is one tentative approval for the generic drug (formoterol fumarate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for PERFOROMIST
| International Patents: | 16 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 3 |
| Clinical Trials: | 5 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PERFOROMIST |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PERFOROMIST |
| 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 |
| AstraZeneca | 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 | NDA | Submissiondate |
|---|---|---|---|---|
| PERFOROMIST | SOLUTION;INHALATION | formoterol fumarate | 022007 | 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 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Mylan Speclt | PERFOROMIST | formoterol fumarate | SOLUTION;INHALATION | 022007-001 | May 11, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Mylan Speclt | PERFOROMIST | formoterol fumarate | SOLUTION;INHALATION | 022007-001 | May 11, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Mylan Speclt | PERFOROMIST | formoterol fumarate | SOLUTION;INHALATION | 022007-001 | May 11, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Mylan Speclt | PERFOROMIST | formoterol fumarate | SOLUTION;INHALATION | 022007-001 | May 11, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for PERFOROMIST
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1660035 | Start Trial |
| Taiwan | I359675 | Start Trial |
| Taiwan | 200507830 | Start Trial |
| Canada | 2438544 | Start Trial |
| Japan | 2015178506 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for PERFOROMIST
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2435025 | 122019000068 | Germany | Start Trial | PRODUCT NAME: KOMBINATION VON GLYCOPYRROLAT, EINSCHLIESSLICH BELIEBIGER PHARMAZEUTISCH VERTRAEGLICHER SALZE, ESTER, ENANTIOMERE, ODER ANDERER DERIVATE DAVON, UND FORMOTEROL, EINSCHLIESSLICH BELIEBIGER PHARMAZEUTISCH VERTRAEGLICHER SALZE, ESTER, ENANTIOMERE, ODER ANDERER DERIVATE DAVON; REGISTRATION NO/DATE: EU/1/18/1339 20181218 |
| 0613371 | 2002C/022 | Belgium | Start Trial | PRODUCT NAME: BUDESONID. MICRONIS. AND FORMOTEROL. FUMARAS DIHYDR., NATL REGISTRATION NO/DATE: 624 IS 234 F 0 20010129; FIRST REGISTRATION: SE 16047 20000825 |
| 2435025 | 132019000000087 | Italy | Start 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 |
| 2435025 | 300995 | Netherlands | Start 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 |
| 2435025 | LUC00124 | Luxembourg | Start 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
