FENTANYL HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for fentanyl hydrochloride and what is the scope of freedom to operate?
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 | ⤷ 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 |
---|---|---|---|
China | 106573136 | 开关验证电路和方法 (Switch validation circuit and method) | ⤷ Try a Trial |
Singapore | 192950 | TWO-PART ELECTROTRANSPORT DEVICE | ⤷ Try a Trial |
Japan | 5813856 | ⤷ Try a Trial | |
Denmark | 2691145 | ⤷ Try a Trial | |
Singapore | 193236 | SWITCH VALIDATION CIRCUIT AND METHOD | ⤷ Try a Trial |
Russian Federation | 2013148572 | ДВУХМОДУЛЬНОЕ УСТРОЙСТВО ЭЛЕКТРОПЕРЕНОСА | ⤷ 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 |
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 |
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 |
1635783 | 300653 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906 |
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 |