FENTANYL-100 Drug Patent Profile
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Which patents cover Fentanyl-100, and what generic alternatives are available?
Fentanyl-100 is a drug marketed by Actavis Labs Ut Inc, Difgen Pharms, Kindeva, Lavipharm Labs, Mayne Pharma, Mylan Technologies, Noven, Specgx Llc, and Zydus Pharms. and is included in nine NDAs.
The generic ingredient in FENTANYL-100 is fentanyl. There are thirty-one drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fentanyl profile page.
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Summary for FENTANYL-100
| US Patents: | 0 |
| Applicants: | 9 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 1,913 |
| Patent Applications: | 4,609 |
| DailyMed Link: | FENTANYL-100 at DailyMed |
Recent Clinical Trials for FENTANYL-100
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Baylor College of Medicine | PHASE1 |
| Christopher D. Verrico | PHASE1 |
| Montefiore Medical Center | PHASE3 |
Pharmacology for FENTANYL-100
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
US Patents and Regulatory Information for FENTANYL-100
| 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-100 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 076709-004 | Aug 20, 2007 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Noven | FENTANYL-100 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 077775-004 | Oct 16, 2009 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Lavipharm Labs | FENTANYL-100 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 077051-004 | Aug 4, 2006 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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-100
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Kyowa Kirin Holdings B.V. | PecFent | fentanyl | EMEA/H/C/001164PecFent 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/000959Instanyl 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/000833Effentora 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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
