FENTANYL-12 Drug Patent Profile
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When do Fentanyl-12 patents expire, and what generic alternatives are available?
Fentanyl-12 is a drug marketed by Difgen Pharms, Kindeva, Mylan Technologies, Specgx Llc, and Zydus Pharms. and is included in five NDAs.
The generic ingredient in FENTANYL-12 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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Questions you can ask:
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Summary for FENTANYL-12
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 38 |
| Clinical Trials: | 1,654 |
| Patent Applications: | 4,362 |
| DailyMed Link: | FENTANYL-12 at DailyMed |
Recent Clinical Trials for FENTANYL-12
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 |
Pharmacology for FENTANYL-12
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
US Patents and Regulatory Information for FENTANYL-12
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Difgen Pharms | FENTANYL-12 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 077449-005 | Sep 11, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Specgx Llc | FENTANYL-12 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 077154-005 | Jun 11, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Kindeva | FENTANYL-12 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 202097-001 | Nov 4, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan Technologies | FENTANYL-12 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 076258-005 | Jan 23, 2007 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Pharms | FENTANYL-12 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 209655-001 | Jan 24, 2023 | 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 |
EU/EMA Drug Approvals for FENTANYL-12
| 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 |
