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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.
DrugPatentWatch® Generic Entry Outlook for Perforomist
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 22, 2021. This may change due to patent challenges or generic licensing.
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 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (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 |
| What excipients (inactive ingredients) are in PERFOROMIST? | PERFOROMIST excipients list |
| DailyMed Link: | PERFOROMIST at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for PERFOROMIST
Generic Entry Date for PERFOROMIST*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INHALATION |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for PERFOROMIST
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Theravance Biopharma | Phase 3 |
| Mylan Inc. | Phase 3 |
| Parexel | 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 | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Mylan Speclt | PERFOROMIST | formoterol fumarate | SOLUTION;INHALATION | 022007-001 | May 11, 2007 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Mylan Speclt | PERFOROMIST | formoterol fumarate | SOLUTION;INHALATION | 022007-001 | May 11, 2007 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| >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 |
|---|---|---|
| Portugal | 1381346 | Get Started for $10 |
| Taiwan | 200507830 | Get Started for $10 |
| Australia | 2002244211 | Get Started for $10 |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for PERFOROMIST
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2435025 | 19C1040 | France | Get Started for $10 | PRODUCT NAME: COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET DE FORMOTEROL (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); NAT. REGISTRATION NO/DATE: EU/1/18/1339 20181220; FIRST REGISTRATION: - EU/1/18/1339 20181220 |
| 2435025 | 122019000068 | Germany | Get Started for $10 | 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 | Get Started for $10 | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
