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Generated: December 11, 2017

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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, Depomed Inc, Cephalon, Sentynl Theraps Inc, Mallinckrodt, and Par Pharm, and is included in seventeen 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-five patent family members in forty-one countries and sixteen supplementary protection certificates in six countries.

There are thirty-one drug master file entries for fentanyl citrate. Seventeen suppliers are listed for this compound.

Pharmacology for fentanyl citrate

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
HospiraFENTANYL CITRATE PRESERVATIVE FREEfentanyl citrateINJECTABLE;INJECTION072786-001Sep 24, 1991APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
CephalonACTIQfentanyl citrateTROCHE/LOZENGE;TRANSMUCOSAL020747-002Nov 4, 1998ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Par PharmFENTANYL CITRATEfentanyl citrateTROCHE/LOZENGE;TRANSMUCOSAL077312-002Oct 30, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sentynl Theraps IncABSTRALfentanyl citrateTABLET;SUBLINGUAL022510-001Jan 7, 2011RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
CephalonACTIQfentanyl citrateTROCHE/LOZENGE;TRANSMUCOSAL020747-005Nov 4, 1998ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Watson LabsFENTANYL CITRATEfentanyl citrateTABLET;BUCCAL, SUBLINGUAL079075-001Jan 7, 2011DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
CephalonFENTORAfentanyl citrateTABLET;BUCCAL, SUBLINGUAL021947-004Sep 25, 2006RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Depomed IncLAZANDAfentanyl citrateSPRAY, METERED;NASAL022569-002Jun 30, 2011RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
CephalonFENTORAfentanyl citrateTABLET;BUCCAL, SUBLINGUAL021947-005Sep 25, 2006RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
CephalonFENTORAfentanyl citrateTABLET;BUCCAL, SUBLINGUAL021947-002Sep 25, 2006RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: fentanyl citrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
CephalonFENTANYLfentanyl citrateTROCHE/LOZENGE;ORAL020195-003Oct 4, 1993► Subscribe► Subscribe
CephalonFENTANYLfentanyl citrateTROCHE/LOZENGE;ORAL020195-001Oct 4, 1993► Subscribe► Subscribe
BdsiONSOLISfentanyl citrateFILM;BUCCAL022266-003Jul 16, 2009► Subscribe► Subscribe
CephalonACTIQfentanyl citrateTROCHE/LOZENGE;TRANSMUCOSAL020747-001Nov 4, 1998► Subscribe► Subscribe
CephalonACTIQfentanyl citrateTROCHE/LOZENGE;TRANSMUCOSAL020747-006Nov 4, 1998► Subscribe► Subscribe
CephalonACTIQfentanyl citrateTROCHE/LOZENGE;TRANSMUCOSAL020747-006Nov 4, 1998► Subscribe► Subscribe
CephalonACTIQfentanyl citrateTROCHE/LOZENGE;TRANSMUCOSAL020747-005Nov 4, 1998► Subscribe► Subscribe
CephalonACTIQfentanyl citrateTROCHE/LOZENGE;TRANSMUCOSAL020747-005Nov 4, 1998► Subscribe► Subscribe
BdsiONSOLISfentanyl citrateFILM;BUCCAL022266-001Jul 16, 2009► Subscribe► Subscribe
CephalonACTIQfentanyl citrateTROCHE/LOZENGE;TRANSMUCOSAL020747-006Nov 4, 1998► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
9,814,705Intranasal spray device containing pharmaceutical composition► Subscribe
8,802,130Sublingual buccal effervescent► Subscribe
5,800,832 Bioerodable film for delivery of pharmaceutical compounds to mucosal surfaces► Subscribe
7,858,121Effervescent oral fentanyl dosage form and methods of administering fentanyl► Subscribe
6,391,335 Effervescent drug delivery system for oral administration► Subscribe
6,576,250 Pharmaceutical compositions for rectal and vaginal administration► Subscribe
6,764,696 Effervescent drug delivery system for oral administration► Subscribe
6,509,036 Effervescent drug delivery system for oral administration► Subscribe
6,350,470 Effervescent drug delivery system for oral administration► Subscribe
8,298,577Effervescent oral opiate dosage forms and methods of administering opiates► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: fentanyl citrate

Country Document Number Estimated Expiration
China100423709► Subscribe
South Korea20120102121► Subscribe
Australia2004204381► Subscribe
Russian Federation2001111025► Subscribe
Germany60042463► Subscribe
Taiwan200611697► Subscribe
New Zealand337289► Subscribe
Argentina048000► Subscribe
Japan2007517054► Subscribe
Israel169480► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: FENTANYL CITRATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB06/022United Kingdom► SubscribePRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
636Luxembourg► SubscribePRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2014000024Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
4Finland► Subscribe
2011000009Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
0714Netherlands► SubscribePRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
0653Netherlands► SubscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
00653Netherlands► SubscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
2015000006Germany► SubscribePRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
2006000022Germany► SubscribePRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
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Serving leading biopharmaceutical companies globally:

Accenture
Chinese Patent Office
Julphar
Citi
Johnson and Johnson
Federal Trade Commission
Cerilliant
Daiichi Sankyo
Chubb
Covington

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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