You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

FENTANYL-50 Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Fentanyl-50 patents expire, and when can generic versions of Fentanyl-50 launch?

Fentanyl-50 is a drug marketed by Actavis Labs Ut Inc, Aveva, Kindeva, Lavipharm Labs, Mayne Pharma, Mylan Technologies, Noven, Specgx Llc, and Zydus Pharms. and is included in nine NDAs.

The generic ingredient in FENTANYL-50 is fentanyl. There are thirty-one drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fentanyl profile page.

Drug patent expirations by year for FENTANYL-50
Recent Clinical Trials for FENTANYL-50

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

SponsorPhase
University Hospital "Sestre Milosrdnice"N/A
National Trauma CenterN/A
University of British ColumbiaPhase 2

See all FENTANYL-50 clinical trials

Pharmacology for FENTANYL-50
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

US Patents and Regulatory Information for FENTANYL-50

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Labs Ut Inc FENTANYL-50 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 076709-002 Aug 20, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Noven FENTANYL-50 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 077775-002 Oct 16, 2009 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lavipharm Labs FENTANYL-50 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 077051-002 Aug 4, 2006 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc FENTANYL-50 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 077154-002 Feb 9, 2011 AB RX 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

EU/EMA Drug Approvals for FENTANYL-50

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Kyowa Kirin Holdings B.V. PecFent fentanyl EMEA/H/C/001164
PecFent is indicated for the management of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equi-analgesic dose of another opioid for a week or longer.
Authorised no no no 2010-08-31
Takeda Pharma A/S Instanyl fentanyl EMEA/H/C/000959
Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Authorised no no no 2009-07-20
Teva B.V. Effentora fentanyl EMEA/H/C/000833
Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain., , BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain., , Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. ,
Authorised no no no 2008-04-04
Incline Therapeutics Europe Ltd Ionsys fentanyl EMEA/H/C/002715
Ionsys is indicated for the management of acute moderate to severe post-operative pain in adult patients.
Withdrawn no no no 2015-11-18
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Make Better Decisions: Try a trial or see plans & pricing

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.