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Last Updated: March 28, 2024

Subsys Drug Patent Profile


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When do Subsys patents expire, 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-two patent family members in seventeen countries.

The generic ingredient in SUBSYS is fentanyl. There are thirty-one drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fentanyl profile page.

DrugPatentWatch® Generic Entry Outlook for Subsys

There have been three 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 are two tentative approvals 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

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Recent Clinical Trials for Subsys

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

SponsorPhase
INSYS Therapeutics IncN/A
Loyola UniversityPhase 3
National Cancer Institute (NCI)Phase 3

See all Subsys clinical trials

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Sublingual fentanyl spray
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Sublingual fentanyl spray
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Sublingual fentanyl spray
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PAIN

Sublingual fentanyl spray
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Sublingual fentanyl spray and methods of treating pain
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PAIN

Sublingual fentanyl spray
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Method of treating pain by administering sublingual fentanyl spray
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PAIN

Sublingual fentanyl spray and methods of use to treat pain
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PAIN

Sublingual fentanyl spray
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-004 Jan 4, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-006 Aug 30, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-007 Aug 30, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-005 Jan 4, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-006 Aug 30, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for Subsys

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Kyowa Kirin Holdings B.V. PecFent fentanyl EMEA/H/C/001164
PecFent is indicated for the management of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equi-analgesic dose of another opioid for a week or longer.
Authorised no no no 2010-08-31
Takeda Pharma A/S Instanyl fentanyl EMEA/H/C/000959
Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Authorised no no no 2009-07-20
Teva B.V. Effentora fentanyl EMEA/H/C/000833
Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain., , BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain., , Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. ,
Authorised no no no 2008-04-04
Incline Therapeutics Europe Ltd Ionsys fentanyl EMEA/H/C/002715
Ionsys is indicated for the management of acute moderate to severe post-operative pain in adult patients.
Withdrawn no no no 2015-11-18
Eli Lilly and Company Limited  Recuvyra fentanyl EMEA/V/C/002239
For the control of pain associated with orthopaedic and soft tissue surgery in dogs.
Withdrawn no no no 2011-10-06
Janssen-Cilag International NV Ionsys fentanyl EMEA/H/C/000612
Management of acute moderate to severe post-operative pain for use in a hospital setting only
Withdrawn no no no 2006-01-24 2008-07-25
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for Subsys

See the table below for patents covering Subsys around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2007087431 ⤷  Try a Trial
Portugal 1976521 ⤷  Try a Trial
Russian Federation 2432950 ПОДЪЯЗЫЧНЫЙ СПРЕЙ НА ОСНОВЕ ФЕНТАНИЛА (SUBLINGUAL FENTANYL-BASED SPRAY) ⤷  Try a Trial
Japan 5241514 ⤷  Try a Trial
Mexico 2020008616 ROCIO DE FENTANILO SUBLINGUAL. (SUBLINGUAL FENTANYL SPRAY.) ⤷  Try a Trial
Canada 2637672 PULVERISATION SUBLINGUALE DE FENTANYLE (SUBLINGUAL FENTANYL SPRAY) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for Subsys

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1635783 C300653 Netherlands ⤷  Try a Trial PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0901368 C300523 Netherlands ⤷  Try a Trial PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
0836511 SPC/GB06/022 United Kingdom ⤷  Try a Trial PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
1769785 C300521 Netherlands ⤷  Try a Trial PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
0975367 122011000009 Germany ⤷  Try a 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 ⤷  Try a 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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