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Last Updated: March 18, 2024

FENTANYL CITRATE Drug Patent Profile


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Which patents cover Fentanyl Citrate, and when can generic versions of Fentanyl Citrate launch?

Fentanyl Citrate is a drug marketed by Abbott, Fresenius Kabi Usa, Hikma, Hospira, Watson Labs, Exela Pharma, Dr Reddys Labs Sa, Actavis Labs Fl Inc, Par Pharm, Specgx Llc, Astrazeneca, and Dr Reddys. and is included in nineteen NDAs.

The generic ingredient in FENTANYL CITRATE is droperidol; fentanyl citrate. There are five drug master file entries for this compound. Additional details are available on the droperidol; fentanyl citrate profile page.

Drug patent expirations by year for FENTANYL CITRATE
Drug Prices for FENTANYL CITRATE

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Recent Clinical Trials for FENTANYL CITRATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of British ColumbiaPhase 4
Chung-Ang University Gwangmyeong HospitalN/A
Ciusss de L'Est de l'Île de MontréalN/A

See all FENTANYL CITRATE clinical trials

Pharmacology for FENTANYL CITRATE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Paragraph IV (Patent) Challenges for FENTANYL CITRATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ABSTRAL Sublingual Tablets fentanyl citrate 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg 022510 1 2014-06-19
FENTORA Buccal Tablets fentanyl citrate 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg 021947 1 2007-11-13
ACTIQ Lozenges fentanyl citrate 0.6 mg 020747 2004-12-20
ACTIQ Lozenges fentanyl citrate 0.8 mg, 1.2 mg and 1.6 mg 020747 2004-11-22
ACTIQ Lozenges fentanyl citrate 0.2 mg 020747 2004-10-29
ACTIQ Lozenges fentanyl citrate 0.4 mg 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
Astrazeneca FENTANYL CITRATE AND DROPERIDOL droperidol; fentanyl citrate INJECTABLE;INJECTION 072028-001 Apr 13, 1989 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Pharm FENTANYL CITRATE fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 077312-006 Oct 30, 2009 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira FENTANYL CITRATE PRESERVATIVE FREE fentanyl citrate INJECTABLE;INJECTION 072786-001 Sep 24, 1991 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Pharm FENTANYL CITRATE fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 077312-002 Oct 30, 2009 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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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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.