DURAGESIC-100 Drug Patent Profile
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Which patents cover Duragesic-100, and what generic alternatives are available?
Duragesic-100 is a drug marketed by Janssen Pharms and is included in one NDA.
The generic ingredient in DURAGESIC-100 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.
Summary for DURAGESIC-100
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 38 |
Clinical Trials: | 26 |
Patent Applications: | 4,426 |
Formulation / Manufacturing: | see details |
DailyMed Link: | DURAGESIC-100 at DailyMed |
Recent Clinical Trials for DURAGESIC-100
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 |
Anatomical Therapeutic Chemical (ATC) Classes for DURAGESIC-100
US Patents and Regulatory Information for DURAGESIC-100
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-100 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813-001 | Aug 7, 1990 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
Expired US Patents for DURAGESIC-100
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Pharms | DURAGESIC-100 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813-001 | Aug 7, 1990 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharms | DURAGESIC-100 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813-001 | Aug 7, 1990 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharms | DURAGESIC-100 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813-001 | Aug 7, 1990 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for DURAGESIC-100
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 DURAGESIC-100
See the table below for patents covering DURAGESIC-100 around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | S6137725 | SKIN ADMINISTRATION OF FENTANYL AND DEVICE | ⤷ Try a Trial |
Italy | 1183912 | SOMMINISTRAZIONE TRANSDERMICA DI FENTANILE E DISPOSITIVO PER TALE SOMMINISTRAZIONE | ⤷ Try a Trial |
Switzerland | 665351 | TRANSDERMALES ABGABESYSTEM ZUR VERABREICHUNG VON FENTANYL. | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DURAGESIC-100
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |