SUBSYS Drug Patent Profile
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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. Eight suppliers are listed for this compound. Additional details are available on the fentanyl profile page.
DrugPatentWatch® 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 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 29 |
Clinical Trials: | 5 |
Patent Applications: | 1,158 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for SUBSYS |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SUBSYS |
What excipients (inactive ingredients) are in SUBSYS? | SUBSYS excipients list |
DailyMed Link: | SUBSYS at DailyMed |


Recent Clinical Trials for SUBSYS
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
INSYS Therapeutics Inc | N/A |
Loyola University | Phase 3 |
INSYS Therapeutics Inc | Phase 3 |
Pharmacology for SUBSYS
Drug Class | Opioid Agonist |
Mechanism of Action | Full Opioid Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for SUBSYS
Paragraph IV (Patent) Challenges for SUBSYS
US Patents and Regulatory Information for SUBSYS
SUBSYS is protected by ten US patents.
Patents protecting SUBSYS
Sublingual fentanyl spray
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Sublingual fentanyl spray
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Sublingual fentanyl spray
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Sublingual fentanyl spray
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN
Sublingual fentanyl spray
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Sublingual fentanyl spray and methods of treating pain
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN
Sublingual fentanyl spray
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Method of treating pain by administering sublingual fentanyl spray
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN
Sublingual fentanyl spray and methods of use to treat pain
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PAIN
Sublingual fentanyl spray
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
International Patents for SUBSYS
See the table below for patents covering SUBSYS around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1976521 | Pulvérisation sublinguale de fentanyle (Sublingual fentanyl spray) | See Plans and Pricing |
Spain | 2535233 | See Plans and Pricing | |
European Patent Office | 2180844 | AÉROSOL SUBLINGUAL DE FENTANYL (SUBLINGUAL FENTANYL SPRAY) | See Plans and Pricing |
Canada | 2637672 | PULVERISATION SUBLINGUALE DE FENTANYLE (SUBLINGUAL FENTANYL SPRAY) | See Plans and Pricing |
Mexico | 2008009522 | ROCIO DE FENTANILO SUBLINGUAL. (SUBLINGUAL FENTANYL SPRAY.) | See Plans and Pricing |
Australia | 2008282743 | Sublingual fentanyl spray | See Plans and Pricing |
European Patent Office | 2641595 | Aörosol sublingual de fentanyl (Sublingual fentanyl spray) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SUBSYS
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0383579 | C960030 | Netherlands | See Plans and Pricing | PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517 |
1635783 | C300653 | Netherlands | See Plans and Pricing | PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906 |
0836511 | 122006000022 | Germany | See Plans and Pricing | PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126 |
0975367 | 122011000009 | Germany | See Plans and Pricing | PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831 |
0836511 | SPC/GB06/022 | United Kingdom | See Plans and Pricing | PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124 |
1635783 | 300653 | Netherlands | See Plans and Pricing | PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906 |
1635783 | 122014000024 | Germany | See Plans and Pricing | 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 |