FENTANYL CITRATE - Generic Drug Details
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What are the generic sources for fentanyl citrate and what is the scope of patent protection?
Fentanyl citrate
is the generic ingredient in nine branded drugs marketed by Adalvo, Abbott, Fresenius Kabi Usa, Hikma, Hospira, Watson Labs, Dr Reddys, Rising, Exela Pharma, Btcp Pharma, Dr Reddys Labs Sa, Cephalon, Sentynl Theraps Inc, Actavis Labs Fl Inc, Par Pharm, and Specgx Llc, and is included in twenty-two NDAs. There are ten patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Fentanyl citrate has one hundred and seventy-two patent family members in thirty-five countries.
There are fifteen drug master file entries for fentanyl citrate. Ten suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for FENTANYL CITRATE
International Patents: | 172 |
US Patents: | 10 |
Tradenames: | 9 |
Applicants: | 16 |
NDAs: | 22 |
Drug Master File Entries: | 15 |
Finished Product Suppliers / Packagers: | 10 |
Raw Ingredient (Bulk) Api Vendors: | 39 |
Clinical Trials: | 105 |
Patent Applications: | 6,596 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for FENTANYL CITRATE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FENTANYL CITRATE |
What excipients (inactive ingredients) are in FENTANYL CITRATE? | FENTANYL CITRATE excipients list |
DailyMed Link: | FENTANYL CITRATE at DailyMed |
Recent Clinical Trials for FENTANYL CITRATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of British Columbia | Phase 4 |
Chung-Ang University Gwangmyeong Hospital | N/A |
Ciusss de L'Est de l'Île de Montréal | N/A |
Generic filers with tentative approvals for FENTANYL CITRATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for FENTANYL CITRATE
Drug Class | Opioid Agonist |
Mechanism of Action | Full Opioid Agonists |
Paragraph IV (Patent) Challenges for FENTANYL CITRATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ABSTRAL | Sublingual Tablets | fentanyl citrate | 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg | 022510 | 1 | 2014-06-19 |
FENTORA | Buccal Tablets | fentanyl citrate | 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg | 021947 | 1 | 2007-11-13 |
ACTIQ | Lozenges | fentanyl citrate | 0.6 mg | 020747 | 2004-12-20 | |
ACTIQ | Lozenges | fentanyl citrate | 0.8 mg, 1.2 mg and 1.6 mg | 020747 | 2004-11-22 | |
ACTIQ | Lozenges | fentanyl citrate | 0.2 mg | 020747 | 2004-10-29 | |
ACTIQ | Lozenges | fentanyl citrate | 0.4 mg | 020747 | 2004-10-06 |
US Patents and Regulatory Information for FENTANYL CITRATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Adalvo | ONSOLIS | fentanyl citrate | FILM;BUCCAL | 022266-003 | Jul 16, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Adalvo | ONSOLIS | fentanyl citrate | FILM;BUCCAL | 022266-005 | Jul 16, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-003 | Sep 25, 2006 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Hospira | FENTANYL CITRATE PRESERVATIVE FREE | fentanyl citrate | INJECTABLE;INJECTION | 072786-001 | Sep 24, 1991 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Specgx Llc | FENTANYL CITRATE | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 078907-003 | Oct 30, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-004 | Nov 4, 1998 | RX | 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 CITRATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-005 | Sep 25, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-002 | Sep 25, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-003 | Sep 25, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-003 | Sep 25, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-001 | Sep 25, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-001 | Sep 25, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FENTANYL CITRATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Argentina | 048029 | FORMAS DE DOSIFICACION ORAL EFERVESCENTE DE OPIACEOS Y METODOS DE ADMINISTRACION DE OPIACEOS | ⤷ Try a Trial |
Croatia | P20161168 | ⤷ Try a Trial | |
Austria | E498395 | ⤷ Try a Trial | |
Serbia | 54764 | SREDSTVO ZA TRANSMUKOZALNU ISPORUKU SA POVEĆANIM NAKUPLJANJEM (TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE) | ⤷ Try a Trial |
Japan | 5685611 | ⤷ Try a Trial | |
Canada | 2548915 | FORME GALENIQUE DE FENTANYL GENERALEMENT LINEAIRE EFFERVESCENTE ET ORALE ET SES PROCEDES D'ADMINISTRATION (GENERALLY LINEAR EFFERVESCENT ORAL FENTANYL DOSAGE FORM AND METHODS OF ADMINISTERING) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FENTANYL CITRATE
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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