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Generated: October 20, 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 West-ward Pharms Int, Mallinckrodt, Sentynl Theraps Inc, Par Pharm, Hospira, Watson Labs Inc, Akorn, Abbott, Cephalon, Bdsi, Depomed Inc, and Watson Labs, 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-four patent family members in forty-one countries and fifteen supplementary protection certificates in six countries.

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

Summary for Generic Name: fentanyl citrate

US Patents:20
Tradenames:9
Applicants:12
NDAs:17
Drug Master File Entries: see list31
Suppliers / Packagers: see list17
Bulk Api Vendors: see list16
Clinical Trials: see list1,321
Patent Applications: see list2,885
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:fentanyl citrate at DailyMed

Pharmacology for Ingredient: 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 Product Substance Delist Req. Exclusivity Expiration
Watson Labs
FENTANYL CITRATE
fentanyl citrate
INJECTABLE;INJECTION073488-001Jun 30, 1992DISCNNoNo► Subscribe► Subscribe► Subscribe
Sentynl Theraps Inc
ABSTRAL
fentanyl citrate
TABLET;SUBLINGUAL022510-003Jan 7, 2011RXYesNo► Subscribe► SubscribeY ► Subscribe
Depomed Inc
LAZANDA
fentanyl citrate
SPRAY, METERED;NASAL022569-001Jun 30, 2011RXYesNo► Subscribe► SubscribeY ► Subscribe
Depomed Inc
LAZANDA
fentanyl citrate
SPRAY, METERED;NASAL022569-002Jun 30, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-002Sep 25, 2006RXYesNo► Subscribe► SubscribeY ► Subscribe
Bdsi
ONSOLIS
fentanyl citrate
FILM;BUCCAL022266-003Jul 16, 2009DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Bdsi
ONSOLIS
fentanyl citrate
FILM;BUCCAL022266-004Jul 16, 2009DISCNNoNo► Subscribe► Subscribe ► Subscribe
Cephalon
FENTANYL
fentanyl citrate
TROCHE/LOZENGE;ORAL020195-001Oct 4, 1993DISCNNoNo► Subscribe► Subscribe► Subscribe
Depomed Inc
LAZANDA
fentanyl citrate
SPRAY, METERED;NASAL022569-002Jun 30, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Bdsi
ONSOLIS
fentanyl citrate
FILM;BUCCAL022266-001Jul 16, 2009DISCNNoNo► Subscribe► Subscribe ► 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
Bdsi
ONSOLIS
fentanyl citrate
FILM;BUCCAL022266-004Jul 16, 2009► Subscribe► Subscribe
Cephalon
ACTIQ
fentanyl citrate
TROCHE/LOZENGE;TRANSMUCOSAL020747-002Nov 4, 1998► Subscribe► Subscribe
Bdsi
ONSOLIS
fentanyl citrate
FILM;BUCCAL022266-005Jul 16, 2009► Subscribe► Subscribe
Cephalon
ACTIQ
fentanyl citrate
TROCHE/LOZENGE;TRANSMUCOSAL020747-006Nov 4, 1998► Subscribe► Subscribe
Cephalon
ACTIQ
fentanyl citrate
TROCHE/LOZENGE;TRANSMUCOSAL020747-005Nov 4, 1998► Subscribe► Subscribe
Cephalon
ACTIQ
fentanyl citrate
TROCHE/LOZENGE;TRANSMUCOSAL020747-005Nov 4, 1998► Subscribe► Subscribe
Bdsi
ONSOLIS
fentanyl citrate
FILM;BUCCAL022266-001Jul 16, 2009► Subscribe► Subscribe
Cephalon
ACTIQ
fentanyl citrate
TROCHE/LOZENGE;TRANSMUCOSAL020747-001Nov 4, 1998► Subscribe► Subscribe
Cephalon
ACTIQ
fentanyl citrate
TROCHE/LOZENGE;TRANSMUCOSAL020747-003Nov 4, 1998► Subscribe► Subscribe
Cephalon
ACTIQ
fentanyl citrate
TROCHE/LOZENGE;TRANSMUCOSAL020747-005Nov 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
6,576,250 Pharmaceutical compositions for rectal and vaginal administration► Subscribe
8,802,130Sublingual buccal effervescent► Subscribe
8,454,996Pharmaceutical composition for the treatment of acute disorders► Subscribe
6,509,036 Effervescent drug delivery system for oral administration► Subscribe
6,391,335 Effervescent drug delivery system for oral administration► Subscribe
8,298,577Effervescent oral opiate dosage forms and methods of administering opiates► Subscribe
6,641,838 Effervescent drug delivery system for oral administration► Subscribe
6,764,696 Effervescent drug delivery system for oral administration► Subscribe
6,350,470 Effervescent drug delivery system for oral administration► Subscribe
8,147,866Transmucosal delivery devices with enhanced uptake► 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
Japan2006516272► Subscribe
South Korea20090033903► Subscribe
Germany69923675► Subscribe
Japan4880657► Subscribe
Norway338567► Subscribe
European Patent Office1082106► Subscribe
Hungary230468► Subscribe
Estonia200100182► Subscribe
Ukraine96455► Subscribe
Japan2002526439► 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
4Finland► Subscribe
0653Netherlands► SubscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
2011000009Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
636Luxembourg► SubscribePRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
C/GB06/022United Kingdom► SubscribePRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
00521Netherlands► SubscribePRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
2015 00004Denmark► SubscribePRODUCT 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
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
00653Netherlands► SubscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
00522Netherlands► SubscribePRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Queensland Health
Argus Health
Dow
McKesson
Chubb
QuintilesIMS
Farmers Insurance
Boehringer Ingelheim
Chinese Patent Office
Fish and Richardson

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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