Fentanyl hydrochloride - Generic Drug Details
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What are the generic sources for fentanyl hydrochloride and what is the scope of patent protection?
Fentanyl hydrochloride
is the generic ingredient in one branded drug marketed by The Medicines Co and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Fentanyl hydrochloride has eighty-nine patent family members in eighteen countries.
There are two drug master file entries for fentanyl hydrochloride.
Summary for fentanyl hydrochloride
| International Patents: | 89 |
| US Patents: | 8 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 12 |
| Clinical Trials: | 1,624 |
| Patent Applications: | 136 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | fentanyl hydrochloride at DailyMed |
Recent Clinical Trials for fentanyl hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Hospital "Sestre Milosrdnice" | N/A |
| National Trauma Center | N/A |
| University of British Columbia | Phase 2 |
US Patents and Regulatory Information for fentanyl hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | 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 |
Expired US Patents for fentanyl hydrochloride
International Patents for fentanyl hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2012238095 | Switch validation circuit and method | ⤷ Try a Trial |
| Spain | 2635242 | ⤷ Try a Trial | |
| Brazil | 112013025000 | dispositivo de transporte elétrico de duas partes | ⤷ Try a Trial |
| Russian Federation | 2014153102 | УПРАВЛЕНИЕ ТОКОМ ДЛЯ ЭЛЕКТРОПЕРЕНОСА ЛЕКАРСТВЕННЫХ ПРЕПАРАТОВ | ⤷ Try a Trial |
| Mexico | 347308 | AUTOPRUEBA PARA PRODUCTO ANALGESICO. (SELF-TEST FOR ANALGESIC PRODUCT.) | ⤷ Try a Trial |
| China | 104519947 | Self-test for analgesic product | ⤷ Try a Trial |
| Mexico | 342033 | CONTROL DE CORRIENTE PARA ADMINISTRACION DE FARMACOS POR ELECTROTRANSPORTE. (CURRENT CONTROL FOR ELECTROTRANSPORT DRUG DELIVERY.) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for fentanyl hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0901368 | C300523 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006 |
| 1769785 | C300521 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FENTANYL; REG 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 |
| 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 |
| 0836511 | 122006000022 | Germany | ⤷ Try a Trial | PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126 |
| 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 |
| 1769785 | C300522 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
