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Serving leading biopharmaceutical companies globally:

Express Scripts
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Generated: February 17, 2018

DrugPatentWatch Database Preview

Fentanyl citrate - Generic Drug Details

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What are the generic sources for fentanyl citrate and what is the scope of fentanyl citrate patent protection?

Fentanyl citrate
is the generic ingredient in nine branded drugs marketed by Bdsi, Abbott, Hospira, Watson Labs, Watson Labs Inc, West-ward Pharms Int, Akorn, Elefsee Pharms Intl, Cephalon, Sentynl Theraps Inc, Actavis Labs Fl Inc, Par Pharm, and Specgx Llc, and is included in eighteen NDAs. There are twenty patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fentanyl citrate has three hundred and fifty-seven patent family members in forty-one countries.

There are thirty-one drug master file entries for fentanyl citrate. Sixteen suppliers are listed for this compound.
Summary for fentanyl citrate
Pharmacology for fentanyl citrate
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

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
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-005 Sep 25, 2006 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Specgx Llc FENTANYL CITRATE fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 078907-006 Oct 30, 2009 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Par Pharm FENTANYL CITRATE fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 077312-004 Oct 30, 2009 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-002 Nov 4, 1998 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Watson Labs FENTANYL CITRATE fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 079075-002 Jan 7, 2011 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-006 Jan 7, 2011 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Elefsee Pharms Intl LAZANDA fentanyl citrate SPRAY, METERED;NASAL 022569-002 Jun 30, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-002 Sep 25, 2006 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-004 Jul 16, 2009 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-005 Jan 7, 2011 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for fentanyl citrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-004 Nov 4, 1998 ➤ Sign Up ➤ Sign Up
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-002 Nov 4, 1998 ➤ Sign Up ➤ Sign Up
Cephalon FENTANYL fentanyl citrate TROCHE/LOZENGE;ORAL 020195-001 Oct 4, 1993 ➤ Sign Up ➤ Sign Up
Cephalon FENTANYL fentanyl citrate TROCHE/LOZENGE;ORAL 020195-007 Oct 30, 1995 ➤ Sign Up ➤ Sign Up
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-001 Nov 4, 1998 ➤ Sign Up ➤ Sign Up
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-001 Nov 4, 1998 ➤ Sign Up ➤ Sign Up
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-006 Nov 4, 1998 ➤ Sign Up ➤ Sign Up
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-001 Jul 16, 2009 ➤ Sign Up ➤ Sign Up
Cephalon FENTANYL fentanyl citrate TROCHE/LOZENGE;ORAL 020195-002 Oct 4, 1993 ➤ Sign Up ➤ Sign Up
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-002 Nov 4, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for fentanyl citrate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,454,996 Pharmaceutical composition for the treatment of acute disorders ➤ Sign Up
9,655,843 Transmucosal delivery devices with enhanced uptake ➤ Sign Up
6,764,696 Effervescent drug delivery system for oral administration ➤ Sign Up
5,800,832 Bioerodable film for delivery of pharmaceutical compounds to mucosal surfaces ➤ Sign Up
8,298,577 Effervescent oral opiate dosage forms and methods of administering opiates ➤ Sign Up
8,512,747 Pharmaceutical composition for the treatment of acute disorders ➤ Sign Up
8,802,130 Sublingual buccal effervescent ➤ Sign Up
6,391,335 Effervescent drug delivery system for oral administration ➤ Sign Up
6,641,838 Effervescent drug delivery system for oral administration ➤ Sign Up
7,858,121 Effervescent oral fentanyl dosage form and methods of administering fentanyl ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for fentanyl citrate

Country Document Number Estimated Expiration
Cyprus 1107711 ➤ Sign Up
Brazil PI0714712 ➤ Sign Up
Australia 3892401 ➤ Sign Up
Australia 2007275581 ➤ Sign Up
Spain 2433930 ➤ Sign Up
Austria 433745 ➤ Sign Up
Canada 2345064 ➤ Sign Up
Germany 69923675 ➤ Sign Up
Croatia P20110336 ➤ Sign Up
Japan 2005281322 ➤ Sign Up
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for fentanyl citrate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00016 Denmark ➤ Sign Up 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
00521 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
00522 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
0653 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
2014000024 Germany ➤ Sign Up PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
2015 00004 Denmark ➤ Sign Up PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
636 Luxembourg ➤ Sign Up PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
00523 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
00653 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
2011000009 Germany ➤ Sign Up PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Cerilliant
Dow
McKinsey
Harvard Business School
Healthtrust
Federal Trade Commission
US Department of Justice
Chinese Patent Office

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 verifification 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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