DURAGESIC-12 Drug Patent Profile
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Which patents cover Duragesic-12, and what generic alternatives are available?
Duragesic-12 is a drug marketed by Janssen Pharms and is included in one NDA.
The generic ingredient in DURAGESIC-12 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.
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Summary for DURAGESIC-12
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 38 |
Clinical Trials: | 26 |
Patent Applications: | 3,988 |
Formulation / Manufacturing: | see details |
DailyMed Link: | DURAGESIC-12 at DailyMed |
![DURAGESIC-12 drug patent expirations Drug patent expirations by year for DURAGESIC-12](/p/graph/s/t/DURAGESIC-12-patent-expirations.png)
Recent Clinical Trials for DURAGESIC-12
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Jiarong Chen, MD | Phase 4 |
Emory University | Phase 4 |
Loyola University | Phase 2/Phase 3 |
US Patents and Regulatory Information for DURAGESIC-12
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Pharms | DURAGESIC-12 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813-005 | Feb 4, 2005 | 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 DURAGESIC-12
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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for DURAGESIC-12
See the table below for patents covering DURAGESIC-12 around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hong Kong | 8191 | TRANSDERMAL ADMINISTRATION OF FENTANYL AND DEVICE THEREFOR | ⤷ Sign Up |
Netherlands | 8501979 | ⤷ Sign Up | |
Spain | 8707667 | ⤷ Sign Up | |
Canada | 1245983 | ADMINISTRATION TRANSCUTANEE DE FENTANYL, ET DISPOSITIF POUR CE FAIRE (TRANSDERMAL ADMINISTRATION OF FENTANYL AND DEVICE THEREFOR) | ⤷ Sign Up |
United Kingdom | 8514445 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DURAGESIC-12
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1769785 | C300521 | Netherlands | ⤷ Sign Up | PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006 |
0836511 | SPC/GB06/022 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124 |
1635783 | 300653 | Netherlands | ⤷ Sign Up | PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906 |
0901368 | C300523 | Netherlands | ⤷ Sign Up | PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006 |
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 |