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Generated: July 24, 2017
What is the patent landscape for Subsys, and when can generic versions of Subsys launch?
Subsys is a drug marketed by Insys Dev Co Inc and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.| Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 21 |
| Clinical Trials: see list | 5 |
| Patent Applications: see list | 6,490 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | SUBSYS at DailyMed |
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Insys Dev Co Inc | SUBSYS | fentanyl | SPRAY;SUBLINGUAL | 202788-006 | Aug 30, 2012 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Insys Dev Co Inc | SUBSYS | fentanyl | SPRAY;SUBLINGUAL | 202788-004 | Jan 4, 2012 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Insys Dev Co Inc | SUBSYS | fentanyl | SPRAY;SUBLINGUAL | 202788-007 | Aug 30, 2012 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Insys Dev Co Inc | SUBSYS | fentanyl | SPRAY;SUBLINGUAL | 202788-006 | Aug 30, 2012 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Insys Dev Co Inc | SUBSYS | fentanyl | SPRAY;SUBLINGUAL | 202788-007 | Aug 30, 2012 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| fentanyl | Sublingual Spray | 0.4 mg/spray | Subsys | 5/22/2017 |
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| New Zealand | 569949 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2637672 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 1976521 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2009017837 | ► Subscribe | |||||||||||||||||||||||||||
| China | 101378735 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 00521 | Netherlands | ► Subscribe | PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006 | ||||||||||||||||||||||||||
| 2014 00016 | Denmark | ► Subscribe | PRODUCT NAME: FENTANYL I EN HVILKEN SOM HELST AF DE FORMER, DER ER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/10/644/001-006 20100831 | ||||||||||||||||||||||||||
| C/GB06/022 | United Kingdom | ► Subscribe | PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124 | ||||||||||||||||||||||||||
| 00522 | Netherlands | ► Subscribe | PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006 | ||||||||||||||||||||||||||
| 0653 | Netherlands | ► Subscribe | PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906 | ||||||||||||||||||||||||||
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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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