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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
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Cipla
Citi
US Army
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Generated: August 19, 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 nineteen patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fentanyl citrate has two hundred and ninety-five patent family members in thirty-nine 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

Tradenames:9
Patents:19
Applicants:12
NDAs:17
Drug Master File Entries: see list31
Suppliers / Packagers: see list17
Bulk Api Vendors: see list16
Clinical Trials: see list1,286
Patent Applications: see list2,767
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
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-002Sep 25, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-004Sep 25, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-005Sep 25, 2006RXYesNo► Subscribe► SubscribeY ► Subscribe
Cephalon
FENTANYL
fentanyl citrate
TROCHE/LOZENGE;ORAL020195-001Oct 4, 1993DISCNNoNo► Subscribe► Subscribe► Subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-006Mar 2, 2007DISCNYesNo► 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
Cephalon
ACTIQ
fentanyl citrate
TROCHE/LOZENGE;TRANSMUCOSAL020747-002Nov 4, 1998► Subscribe► Subscribe
Cephalon
FENTANYL
fentanyl citrate
TROCHE/LOZENGE;ORAL020195-007Oct 30, 1995► Subscribe► Subscribe
Bdsi
ONSOLIS
fentanyl citrate
FILM;BUCCAL022266-001Jul 16, 2009► Subscribe► Subscribe
Cephalon
ACTIQ
fentanyl citrate
TROCHE/LOZENGE;TRANSMUCOSAL020747-005Nov 4, 1998► Subscribe► Subscribe
Cephalon
ACTIQ
fentanyl citrate
TROCHE/LOZENGE;TRANSMUCOSAL020747-001Nov 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
8,298,577Effervescent oral opiate dosage forms and methods of administering opiates► Subscribe
6,764,696 Effervescent drug delivery system for oral administration► Subscribe
6,350,470 Effervescent drug delivery system for oral administration► Subscribe
8,454,996Pharmaceutical composition for the treatment of acute disorders► Subscribe
6,576,250 Pharmaceutical compositions for rectal and vaginal administration► 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
Spain2207295► Subscribe
Portugal1115383► Subscribe
South Korea101184138► Subscribe
Argentina048000► Subscribe
Japan4478512► 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
2006000022Germany► SubscribePRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
2014000024Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
00714Netherlands► SubscribePRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
00523Netherlands► SubscribePRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
0653Netherlands► SubscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Baxter
US Army
Harvard Business School
Johnson and Johnson
Teva
US Department of Justice
Medtronic
Julphar
Merck
Mallinckrodt

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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