Fentanyl - Generic Drug Details
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What are the generic drug sources for fentanyl and what is the scope of patent protection?
Fentanyl
is the generic ingredient in twenty-five branded drugs marketed by Janssen Pharms, Actavis Labs Ut Inc, Aveva, Kindeva, Lavipharm Labs, Mayne Pharma, Mylan Technologies, Noven, Specgx Llc, Btcp Pharma, Adalvo, Abbott, Fresenius Kabi Usa, Hospira, Watson Labs, Dr Reddys, Hikma, Akorn, Cephalon, Sentynl Theraps Inc, Actavis Labs Fl Inc, Par Pharm, and The Medicines Co, and is included in thirty-two NDAs. There are twenty-nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Fentanyl has thirty-two patent family members in seventeen countries.
There are thirty-one drug master file entries for fentanyl. Seven suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for fentanyl
International Patents: | 32 |
US Patents: | 29 |
Tradenames: | 25 |
Applicants: | 23 |
NDAs: | 32 |
Drug Master File Entries: | 31 |
Finished Product Suppliers / Packagers: | 7 |
Raw Ingredient (Bulk) Api Vendors: | 31 |
Clinical Trials: | 1,586 |
Patent Applications: | 6,865 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for fentanyl |
Drug Sales Revenues: | Drug sales revenues 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 |
---|---|
McMaster Children's Hospital | Phase 4 |
Icahn School of Medicine at Mount Sinai | Phase 3 |
Bicycle Health | Phase 4 |
Generic filers with tentative approvals for FENTANYL
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 800MCG | TABLET;BUCCAL |
See Plans and Pricing | See Plans and Pricing | 600MCG | TABLET;BUCCAL |
See Plans and Pricing | See Plans and Pricing | 400MCG | TABLET;BUCCAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for fentanyl
Drug Class | Opioid Agonist |
Mechanism of Action | Full Opioid Agonists |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Btcp Pharma | SUBSYS | fentanyl | SPRAY;SUBLINGUAL | 202788-005 | Jan 4, 2012 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Specgx Llc | FENTANYL-100 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 077154-004 | Feb 9, 2011 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Cephalon | FENTANYL | fentanyl citrate | TROCHE/LOZENGE;ORAL | 020195-001 | Oct 4, 1993 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Watson Labs | FENTANYL CITRATE | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 079075-002 | Jan 7, 2011 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 |
---|---|---|---|---|---|---|---|
Janssen Pharms | DURAGESIC-100 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813-001 | Aug 7, 1990 | See Plans and Pricing | See Plans and Pricing |
Janssen Pharms | DURAGESIC-50 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813-003 | Aug 7, 1990 | See Plans and Pricing | See Plans and Pricing |
Janssen Pharms | DURAGESIC-75 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813-002 | Aug 7, 1990 | See Plans and Pricing | See Plans and Pricing |
Janssen Pharms | DURAGESIC-50 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813-003 | Aug 7, 1990 | See Plans and Pricing | See Plans and Pricing |
>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
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Portugal | 2180844 | See Plans and Pricing | |
Slovenia | 1976521 | See Plans and Pricing | |
Spain | 2668366 | See Plans and Pricing | |
European Patent Office | 2641595 | Aörosol sublingual de fentanyl (Sublingual fentanyl spray) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for fentanyl
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0836511 | 122006000022 | Germany | See Plans and Pricing | PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126 |
1769785 | C300522 | Netherlands | See Plans and Pricing | PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006 |
0901368 | C300523 | Netherlands | See Plans and Pricing | PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006 |
1635783 | C300653 | Netherlands | See Plans and Pricing | 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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