DURAGESIC-75 Drug Patent Profile
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Which patents cover Duragesic-75, and what generic alternatives are available?
Duragesic-75 is a drug marketed by Janssen Pharms and is included in one NDA.
The generic ingredient in DURAGESIC-75 is fentanyl. There are thirty-one drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fentanyl profile page.
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Summary for DURAGESIC-75
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 26 |
| Patent Applications: | 4,791 |
| DailyMed Link: | DURAGESIC-75 at DailyMed |
Recent Clinical Trials for DURAGESIC-75
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-75
| 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-75 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813-002 | Aug 7, 1990 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for DURAGESIC-75
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | DURAGESIC-75 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813-002 | Aug 7, 1990 | 4,060,084 | ⤷ Start Trial |
| Janssen Pharms | DURAGESIC-75 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813-002 | Aug 7, 1990 | 4,144,317 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for DURAGESIC-75
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Kyowa Kirin Holdings B.V. | PecFent | fentanyl | EMEA/H/C/001164PecFent 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/000959Instanyl 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/000833Effentora 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/002715Ionsys 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/002239For 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-75
See the table below for patents covering DURAGESIC-75 around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 4452785 | ⤷ Start Trial | |
| Australia | 565177 | ⤷ Start Trial | |
| Belgium | 902884 | ⤷ Start Trial | |
| Belgium | 905568 | ⤷ Start Trial | |
| Canada | 1245983 | ADMINISTRATION TRANSCUTANEE DE FENTANYL, ET DISPOSITIF POUR CE FAIRE (TRANSDERMAL ADMINISTRATION OF FENTANYL AND DEVICE THEREFOR) | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DURAGESIC-75
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0836511 | CA 2006 00019 | Denmark | ⤷ Start Trial | PRODUCT NAME: FENTANYL HYDROCHLORID |
| 0836511 | SPC/GB06/022 | United Kingdom | ⤷ Start Trial | PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124 |
| 0901368 | C300523 | Netherlands | ⤷ Start Trial | PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006 |
| 1769785 | C300522 | Netherlands | ⤷ Start Trial | PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006 |
| 1769785 | C300521 | Netherlands | ⤷ Start Trial | PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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