DrugPatentWatch Database Preview
PERFOROMIST Drug Profile
Which patents cover Perforomist, and what generic alternatives are available?
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.
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 |
Recent Litigation for PERFOROMIST
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Dey LP v. Teva Parenteral Medicines Inc. | 2014-04-28 |
| DEY, L. P. v. TEVA PARENTERAL MEDICINES, INC. | 2009-06-23 |
| Dey, L.P. v. Sepracor, Inc. | 2007-03-21 |
Pharmacology for PERFOROMIST
| Drug Class | beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists |
Synonyms for PERFOROMIST
| (E)-but-2-enedioic acid; N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(2R)-1-(4-methoxyphenyl)propan-2-yl]amino]ethyl]phenyl]formamide; hydrate |
| AC1OCEVQ |
| Atimos |
| Atock |
| BD-40A |
| Broncoral |
| CGP-25827A |
| Eformoterol fumarate |
| Eolus |
| Foradil Aerolizer |
| Foradil Certihaler |
| Formoterol Easyhaler |
| FORMOTEROL FUMARATE |
| Oxeze Turbuhaler |
| Oxis Turbuhaler |
| PT-005 |
| YM-08316 |
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 |
|---|---|---|
| Taiwan | I359675 | Start Trial |
| Japan | 6214925 | Start Trial |
| Portugal | 1381346 | Start Trial |
| Japan | 2015178506 | Start Trial |
| Japan | 2013155208 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for PERFOROMIST
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0613371 | SPC/GB02/033 | United Kingdom | Start Trial | PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515 |
| 2435025 | PA2019014 | Lithuania | Start Trial | PRODUCT NAME: GLIKOPIROLATO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) IR FORMOTEROLIO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) DERINYS; REGISTRATION NO/DATE: EU/1/18/1339 20181218 |
| 2435025 | 300995 | Netherlands | Start Trial | PRODUCT NAME: EEN COMBINATIE VAN GLYCOPYRROLAAT (MET INBEGRIP VAN ALLE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, ENANTIOMEREN OF ANDERE DERIVATEN DAARVAN) EN FORMOTEROL (MET INBEGRIP VAN ALLE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, ENANTIOMEREN OF ANDERE DERIVATEN DAARVAN); REGISTRATION NO/DATE: EU/ 1/18/1339 20181220 |
| 2435025 | CA 2019 00032 | Denmark | Start Trial | PRODUCT NAME: KOMBINATION AF GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF, OG FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF; REG. NO/DATE: EU/1/18/1339 20181220 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
