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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, 3m Drug Delivery, Actavis Labs Ut Inc, Aveva, Lavipharm Labs, Mayne Pharma, Mylan Technologies, Noven, Specgx Llc, Btcp Pharma, Bdsi, Abbott, Hospira, Watson Labs, Dr Reddys, Fresenius Kabi Usa, Hikma, Akorn, Cephalon, Sentynl Theraps Inc, Actavis Labs Fl Inc, Par Pharm, and The Medicines Co, and is included in thirty NDAs. There are thirty patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Fentanyl has thirty-one patent family members in seventeen countries.
There are thirty-one drug master file entries for fentanyl. Ten suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for fentanyl
| International Patents: | 31 |
| US Patents: | 30 |
| Tradenames: | 25 |
| Applicants: | 23 |
| NDAs: | 30 |
| Drug Master File Entries: | 31 |
| Suppliers / Packagers: | 10 |
| Bulk Api Vendors: | 27 |
| Clinical Trials: | 1,191 |
| Patent Applications: | 6,831 |
| 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 |
| DailyMed Link: | fentanyl at DailyMed |
Recent Clinical Trials for fentanyl
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Helse Fonna | Phase 4 |
| Nanfang Hospital of Southern Medical University | Phase 4 |
| Assiut University | Phase 4 |
Generic filers with tentative approvals for FENTANYL
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 800MCG | TABLET;BUCCAL |
| Start Trial | Start Trial | 600MCG | TABLET;BUCCAL |
| Start Trial | Start Trial | 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
Paragraph IV (Patent) Challenges for FENTANYL
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SUBSYS | SPRAY;SUBLINGUAL | fentanyl | 202788 | 2017-12-07 |
| SUBSYS | SPRAY;SUBLINGUAL | fentanyl | 202788 | 2017-05-22 |
| DURAGESIC-12 | FILM, EXTENDED RELEASE;TRANSDERMAL | fentanyl | 019813 | |
| DURAGESIC-75 | FILM, EXTENDED RELEASE;TRANSDERMAL | fentanyl | 019813 | |
| DURAGESIC-25 | FILM, EXTENDED RELEASE;TRANSDERMAL | fentanyl | 019813 | |
| DURAGESIC-37 | FILM, EXTENDED RELEASE;TRANSDERMAL | fentanyl | 019813 | |
| DURAGESIC-100 | FILM, EXTENDED RELEASE;TRANSDERMAL | fentanyl | 019813 | |
| DURAGESIC-50 | FILM, EXTENDED RELEASE;TRANSDERMAL | fentanyl | 019813 |
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 | 202788-001 | Jan 4, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Mylan Technologies | FENTANYL-62 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 076258-007 | Dec 29, 2014 | RX | No | No | Start Trial | Start Trial | Start Trial | ||||
| Aveva | FENTANYL-12 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 077449-005 | Sep 11, 2015 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Btcp Pharma | SUBSYS | fentanyl | SPRAY;SUBLINGUAL | 202788-004 | Jan 4, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >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-75 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813-002 | Aug 7, 1990 | Start Trial | Start Trial |
| Janssen Pharms | DURAGESIC-25 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813-004 | Aug 7, 1990 | Start Trial | Start Trial |
| Janssen Pharms | DURAGESIC-100 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813-001 | Aug 7, 1990 | Start Trial | Start Trial |
| Janssen Pharms | DURAGESIC-100 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813-001 | Aug 7, 1990 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for fentanyl
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2668366 | Start Trial |
| Japan | 2009528272 | Start Trial |
| Australia | 2008282743 | Start Trial |
| Japan | 5630877 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for fentanyl
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1769785 | C300521 | Netherlands | Start Trial | PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006 |
| 0975367 | 122011000009 | Germany | Start Trial | PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831 |
| 1635783 | CA 2014 00016 | Denmark | Start Trial | PRODUCT NAME: FENTANYL I EN HVILKEN SOM HELST AF DE FORMER, DER ER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/10/644/001-006 20100831 |
| 1635783 | 122014000024 | Germany | Start Trial | PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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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