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Generated: July 20, 2017
Which patents cover Perforomist, and what generic Perforomist alternatives are available?
Perforomist is a drug marketed by Mylan Speclt and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.| Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 48 |
| Clinical Trials: see list | 4 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | PERFOROMIST at DailyMed |
| Drug Class | beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists |
| 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 | 7,348,362 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Mylan Speclt | PERFOROMIST | formoterol fumarate | SOLUTION;INHALATION | 022007-001 | May 11, 2007 | RX | Yes | Yes | 7,462,645 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Mylan Speclt | PERFOROMIST | formoterol fumarate | SOLUTION;INHALATION | 022007-001 | May 11, 2007 | RX | Yes | Yes | 8,623,922 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Mylan Speclt | PERFOROMIST | formoterol fumarate | SOLUTION;INHALATION | 022007-001 | May 11, 2007 | RX | Yes | Yes | 6,667,344 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Mylan Speclt | PERFOROMIST | formoterol fumarate | SOLUTION;INHALATION | 022007-001 | May 11, 2007 | RX | Yes | Yes | 6,814,953 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| formoterol fumarate | CapsulesInhalation Solution | 0.02 mg/2 mL | Perforomist | 1/21/2009 |
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,465,756 | Bronchodilating beta-agonist compositions and methods | ► Subscribe | |||||||||||||||||||||||||||
| 7,541,385 | Bronchodilating .beta.-agonist compositions and methods | ► Subscribe | |||||||||||||||||||||||||||
| 8,114,912 | Bronchodilating .beta.-agonist compositions and methods | ► Subscribe | |||||||||||||||||||||||||||
| 7,473,710 | Bronchodilating beta-agonist compositions and methods | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| European Patent Office | 1381346 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2554476 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2004532217 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2002244211 | ► Subscribe | |||||||||||||||||||||||||||
| Taiwan | 200507830 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB02/033 | United Kingdom | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 02C/022 | Belgium | ► Subscribe | PRODUCT NAME: BUDESONID. MICRONIS. AND FORMOTEROL. FUMARAS DIHYDR., NATL REGISTRATION NO/DATE: 624 IS 234 F 0 20010129; FIRST REGISTRATION: SE 16047 20000825 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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