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SUBSYS Drug Profile
» See Plans and Pricing
Which patents cover Subsys, and when can generic versions of Subsys launch?
Subsys is a drug marketed by Btcp Pharma and is included in one NDA. There are ten patents protecting this drug and two Paragraph IV challenges.
This drug has thirty-one patent family members in seventeen countries.
The generic ingredient in SUBSYS is fentanyl. There are thirty-one drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the fentanyl profile page.
US ANDA Litigation and Generic Entry Outlook for Subsys
There have been two 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 (fentanyl), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for SUBSYS
| International Patents: | 31 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 28 |
| Clinical Trials: | 5 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SUBSYS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SUBSYS |
| DailyMed Link: | SUBSYS at DailyMed |
Recent Clinical Trials for SUBSYS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| INSYS Therapeutics Inc | Phase 2 |
| INSYS Therapeutics Inc | N/A |
| Loyola University | Phase 3 |
Pharmacology for SUBSYS
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
US Patents and Regulatory Information for SUBSYS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Btcp Pharma | SUBSYS | fentanyl | SPRAY;SUBLINGUAL | 202788-005 | Jan 4, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Btcp Pharma | SUBSYS | fentanyl | SPRAY;SUBLINGUAL | 202788-004 | Jan 4, 2012 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Btcp Pharma | SUBSYS | fentanyl | SPRAY;SUBLINGUAL | 202788-006 | Aug 30, 2012 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Btcp Pharma | SUBSYS | fentanyl | SPRAY;SUBLINGUAL | 202788-007 | Aug 30, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Btcp Pharma | SUBSYS | fentanyl | SPRAY;SUBLINGUAL | 202788-005 | Jan 4, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Btcp Pharma | SUBSYS | fentanyl | SPRAY;SUBLINGUAL | 202788-006 | Aug 30, 2012 | RX | Yes | No | 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 SUBSYS
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 2180844 | Start Trial |
| Japan | 2009528272 | Start Trial |
| Mexico | 2008009522 | Start Trial |
| Spain | 2668366 | Start Trial |
| Portugal | 1976521 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2009017837 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SUBSYS
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1635783 | 122014000024 | Germany | Start Trial | PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831 |
| 1635783 | CA 2014 00016 | Denmark | Start Trial | 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 |
| 1769785 | C300521 | Netherlands | Start Trial | PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006 |
| 0901368 | C300523 | Netherlands | Start Trial | PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006 |
| 0836511 | CA 2006 00019 | Denmark | Start Trial | PRODUCT NAME: FENTANYL HYDROCHLORID |
| 0975367 | 122011000009 | Germany | Start Trial | PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
