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Fentanyl citrate - Generic Drug Details
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What are the generic drug sources for fentanyl citrate and what is the scope of patent protection?
Fentanyl citrate
is the generic ingredient in nine branded drugs marketed by Bdsi, Abbott, Fresenius Kabi Usa, Hospira, Watson Labs, Dr Reddys, Hikma, Akorn, Btcp Pharma, Cephalon, Sentynl Theraps Inc, Actavis Labs Fl Inc, Par Pharm, and Specgx Llc, and is included in twenty NDAs. There are eleven 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 ninety-six patent family members in thirty-five countries.
There are thirty-one drug master file entries for fentanyl citrate. Ten suppliers are listed for this compound.
Summary for fentanyl citrate
| International Patents: | 196 |
| US Patents: | 11 |
| Tradenames: | 9 |
| Applicants: | 14 |
| NDAs: | 20 |
| Drug Master File Entries: | 31 |
| Suppliers / Packagers: | 10 |
| Bulk Api Vendors: | 28 |
| Clinical Trials: | 74 |
| Patent Applications: | 3,560 |
| 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 |
| DailyMed Link: | fentanyl citrate at DailyMed |
Recent Clinical Trials for fentanyl citrate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Tribhuvan University Teaching Hospital, Institute Of Medicine. | Phase 4 |
| Keith M. Vogt, MD, PhD | Phase 4 |
| McGill University | Phase 2/Phase 3 |
Pharmacology for fentanyl citrate
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
Paragraph IV (Patent) Challenges for FENTANYL CITRATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ABSTRAL | TABLET;SUBLINGUAL | fentanyl citrate | 022510 | 2014-06-19 |
| FENTORA | TABLET;BUCCAL, SUBLINGUAL | fentanyl citrate | 021947 | 2007-11-13 |
| ACTIQ | TROCHE/LOZENGE;TRANSMUCOSAL | fentanyl citrate | 020747 | 2004-12-20 |
| ACTIQ | TROCHE/LOZENGE;TRANSMUCOSAL | fentanyl citrate | 020747 | 2004-11-22 |
| ACTIQ | TROCHE/LOZENGE;TRANSMUCOSAL | fentanyl citrate | 020747 | 2004-10-29 |
| ACTIQ | TROCHE/LOZENGE;TRANSMUCOSAL | fentanyl citrate | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-002 | Jan 7, 2011 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-005 | Sep 25, 2006 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Specgx Llc | FENTANYL CITRATE | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 078907-002 | Oct 30, 2009 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Bdsi | ONSOLIS | fentanyl citrate | FILM;BUCCAL | 022266-004 | Jul 16, 2009 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Specgx Llc | FENTANYL CITRATE | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 078907-004 | Oct 30, 2009 | AB | RX | No | No | Start Trial | Start Trial | Start 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 | Start Trial | Start Trial |
| Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-006 | Nov 4, 1998 | Start Trial | Start Trial |
| Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-004 | Jan 7, 2011 | Start Trial | Start Trial |
| Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-005 | Nov 4, 1998 | Start Trial | Start Trial |
| Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-005 | Jan 7, 2011 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for fentanyl citrate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 100423709 | Start Trial |
| Canada | 2658585 | Start Trial |
| Norway | 338714 | Start Trial |
| Hong Kong | 1193566 | Start Trial |
| China | 1901891 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for fentanyl citrate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0975367 | 122011000009 | Germany | Start 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 | Start Trial | PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126 |
| 0836511 | CA 2006 00019 | Denmark | Start Trial | PRODUCT NAME: FENTANYL HYDROCHLORID |
| 1635783 | 122014000024 | Germany | Start Trial | PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831 |
| 1769785 | C300522 | Netherlands | Start 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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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ISSN: 2162-2639
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.
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