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-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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for SUBSYS?
- What are the global sales for SUBSYS?
- What is Average Wholesale Price for SUBSYS?
Summary for SUBSYS
International Patents: | 32 |
US Patents: | 10 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 38 |
Clinical Trials: | 5 |
Patent Applications: | 2,151 |
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 |
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Sublingual fentanyl spray
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Sublingual fentanyl spray
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Sublingual fentanyl spray
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PAIN
Sublingual fentanyl spray
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Sublingual fentanyl spray and methods of treating pain
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PAIN
Sublingual fentanyl spray
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Method of treating pain by administering sublingual fentanyl spray
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PAIN
Sublingual fentanyl spray and methods of use to treat pain
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PAIN
Sublingual fentanyl spray
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Btcp Pharma | SUBSYS | fentanyl | SPRAY;SUBLINGUAL | 202788-004 | Jan 4, 2012 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Btcp Pharma | SUBSYS | fentanyl | SPRAY;SUBLINGUAL | 202788-006 | Aug 30, 2012 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | |
>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 |
---|---|---|---|
Australia | 2008282743 | Sublingual fentanyl spray | ⤷ Sign Up |
Denmark | 1976521 | ⤷ Sign Up | |
Japan | 2013056928 | SUBLINGUAL FENTANYL SPRAY | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SUBSYS
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0836511 | SPC/GB06/022 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124 |
1635783 | 122014000024 | Germany | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 |