FENTANYL HYDROCHLORIDE - Generic Drug Details
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What are the generic drug 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FENTANYL HYDROCHLORIDE
Generic Entry Date for FENTANYL HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
Dosage:
SYSTEM;IONTOPHORESIS, TRANSDERMAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 |
British Columbia Cancer Agency | 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 | 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 | ||||
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
The Medicines Co | IONSYS | fentanyl hydrochloride | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 021338-001 | May 22, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FENTANYL HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | 112013024783 | circuito de validação de comutador e método | ⤷ Try a Trial |
Denmark | 2691148 | ⤷ Try a Trial | |
Canada | 2828617 | DISPOSITIF DE TRANSPORT D'ELECTRONS CONSTITUE DE DEUX PARTIES (TWO-PART ELECTROTRANSPORT DEVICE) | ⤷ Try a Trial |
Portugal | 2691145 | ⤷ 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 |
---|---|---|---|---|
1635783 | 122014000024 | 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 |
0836511 | CA 2006 00019 | Denmark | ⤷ Try a Trial | PRODUCT NAME: FENTANYL HYDROCHLORID |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |