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PERFOROMIST Drug 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. 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
Perforomist was eligible for patent challenges on December 31, 1968.
There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
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 |
|---|---|
| Theravance Biopharma | Phase 3 |
| Mylan Inc. | 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 | |||
| >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 |
| Australia | 2002244211 | 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 | 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 | 36/2019 | Austria | Start Trial | PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
