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Last Updated: March 29, 2024

FENTANYL-62 Drug Patent Profile


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When do Fentanyl-62 patents expire, and when can generic versions of Fentanyl-62 launch?

Fentanyl-62 is a drug marketed by Aveva, Mylan Technologies, Specgx Llc, and Zydus Pharms. and is included in four NDAs.

The generic ingredient in FENTANYL-62 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-62
Recent Clinical Trials for FENTANYL-62

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-62 clinical trials

Pharmacology for FENTANYL-62
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

US Patents and Regulatory Information for FENTANYL-62

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aveva FENTANYL-62 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 077449-007 Dec 6, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms FENTANYL-62 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 209655-005 Jan 24, 2023 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Technologies FENTANYL-62 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 076258-007 Dec 29, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc FENTANYL-62 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 077154-007 Jan 14, 2020 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-62

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
Eli Lilly and Company Limited  Recuvyra fentanyl EMEA/V/C/002239
For the control of pain associated with orthopaedic and soft tissue surgery in dogs.
Withdrawn no no no 2011-10-06
Janssen-Cilag International NV Ionsys fentanyl EMEA/H/C/000612
Management of acute moderate to severe post-operative pain for use in a hospital setting only
Withdrawn no no no 2006-01-24 2008-07-25
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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