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Last Updated: May 28, 2022

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

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Drug patent expirations by year for SUBSYS
Drug Prices for SUBSYS

See drug prices for SUBSYS

Recent Clinical Trials for SUBSYS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
INSYS Therapeutics IncN/A
Loyola UniversityPhase 3
INSYS Therapeutics IncPhase 3

See all SUBSYS clinical trials

Pharmacology for SUBSYS
Drug Class Opioid Agonist
Mechanism of ActionFull Opioid Agonists
Paragraph IV (Patent) Challenges for SUBSYS
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SUBSYS Sublingual Spray fentanyl 0.1 mg/spray, 0.2 mg/spray, 0.6 mg/spray, 0.8 mg/spray, 1.2 mg/spray, 1.6 mg/spray 202788 1 2017-12-07
SUBSYS Sublingual Spray fentanyl 0.4 mg/spray 202788 1 2017-05-22

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

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-004 Jan 4, 2012 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-006 Aug 30, 2012 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-007 Aug 30, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-005 Jan 4, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-006 Aug 30, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-006 Aug 30, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
Baxter
McKesson
Moodys
Medtronic
AstraZeneca

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 verification 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.