FENTANYL Drug Patent Profile
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Which patents cover Fentanyl, and when can generic versions of Fentanyl launch?
Fentanyl is a drug marketed by Cephalon, Abbott, Fresenius Kabi Usa, Hikma, Hospira, Watson Labs, Exela Pharma, Dr Reddys Labs Sa, Actavis Labs Fl Inc, Par Pharm, Specgx Llc, Astrazeneca, Dr Reddys, Actavis Labs Ut Inc, Difgen Pharms, Kindeva, Lavipharm Labs, Mayne Pharma, Mylan Technologies, Noven, and Zydus Pharms. and is included in twenty-nine NDAs.
The generic ingredient in FENTANYL is fentanyl. There are thirty-one drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fentanyl profile page.
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Summary for FENTANYL
| US Patents: | 0 |
| Applicants: | 21 |
| NDAs: | 29 |
| Raw Ingredient (Bulk) Api Vendors: | 38 |
| Clinical Trials: | 1,654 |
| Patent Applications: | 4,273 |
| Drug Prices: | Drug price information for FENTANYL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FENTANYL |
| What excipients (inactive ingredients) are in FENTANYL? | FENTANYL excipients list |
| DailyMed Link: | FENTANYL at DailyMed |
Recent Clinical Trials for FENTANYL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Alabama at Birmingham | Phase 1 |
| Merck Sharp & Dohme LLC | N/A |
| University Hospital "Sestre Milosrdnice" | N/A |
Medical Subject Heading (MeSH) Categories for FENTANYL
Anatomical Therapeutic Chemical (ATC) Classes for FENTANYL
Paragraph IV (Patent) Challenges for FENTANYL
US Patents and Regulatory Information for FENTANYL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zydus Pharms | FENTANYL-25 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 209655-002 | Jan 24, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zydus Pharms | FENTANYL-87 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 209655-007 | Jan 24, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Specgx Llc | FENTANYL CITRATE | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 078907-005 | Oct 30, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Par Pharm | FENTANYL CITRATE | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 077312-002 | Oct 30, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for FENTANYL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cephalon | FENTANYL | fentanyl citrate | TROCHE/LOZENGE;ORAL | 020195-007 | Oct 30, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Cephalon | FENTANYL | fentanyl citrate | TROCHE/LOZENGE;ORAL | 020195-003 | Oct 4, 1993 | ⤷ Sign Up | ⤷ Sign Up |
| Cephalon | FENTANYL | fentanyl citrate | TROCHE/LOZENGE;ORAL | 020195-002 | Oct 4, 1993 | ⤷ Sign Up | ⤷ Sign Up |
| Cephalon | FENTANYL | fentanyl citrate | TROCHE/LOZENGE;ORAL | 020195-001 | Oct 4, 1993 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for FENTANYL
| 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 |
International Patents for FENTANYL
See the table below for patents covering FENTANYL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2089027 | ⤷ Sign Up | |
| Japan | 2580076 | ⤷ Sign Up | |
| Norway | 920856 | ⤷ Sign Up | |
| Australia | 6337190 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FENTANYL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1635783 | 122014000024 | Germany | ⤷ Sign Up | PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831 |
| 1769785 | C300522 | Netherlands | ⤷ Sign Up | PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006 |
| 0836511 | 122006000022 | Germany | ⤷ Sign Up | PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126 |
| 1635783 | C300653 | Netherlands | ⤷ Sign Up | PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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