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Generated: August 19, 2017
What are the generic sources for fentanyl citrate and what is the scope of fentanyl citrate patent protection?
Fentanyl citrate is the generic ingredient in nine branded drugs marketed by West-ward Pharms Int, Mallinckrodt, Sentynl Theraps Inc, Par Pharm, Hospira, Watson Labs Inc, Akorn, Abbott, Cephalon, Bdsi, Depomed Inc, and Watson Labs, and is included in seventeen NDAs. There are nineteen patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 9 |
| Patents: | 19 |
| Applicants: | 12 |
| NDAs: | 17 |
| Drug Master File Entries: see list | 31 |
| Suppliers / Packagers: see list | 17 |
| Bulk Api Vendors: see list | 16 |
| Clinical Trials: see list | 1,286 |
| Patent Applications: see list | 2,767 |
| Therapeutic Class: | Analgesics |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | fentanyl citrate at DailyMed |
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-002 | Sep 25, 2006 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-004 | Sep 25, 2006 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-005 | Sep 25, 2006 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Cephalon | FENTANYL | fentanyl citrate | TROCHE/LOZENGE;ORAL | 020195-001 | Oct 4, 1993 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-006 | Mar 2, 2007 | DISCN | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-002 | Nov 4, 1998 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Cephalon | FENTANYL | fentanyl citrate | TROCHE/LOZENGE;ORAL | 020195-007 | Oct 30, 1995 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Bdsi | ONSOLIS | fentanyl citrate | FILM;BUCCAL | 022266-001 | Jul 16, 2009 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-005 | Nov 4, 1998 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-001 | Nov 4, 1998 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,298,577 | Effervescent oral opiate dosage forms and methods of administering opiates | ► Subscribe | |||||||||||||||||||||||||||
| 6,764,696 | Effervescent drug delivery system for oral administration | ► Subscribe | |||||||||||||||||||||||||||
| 6,350,470 | Effervescent drug delivery system for oral administration | ► Subscribe | |||||||||||||||||||||||||||
| 8,454,996 | Pharmaceutical composition for the treatment of acute disorders | ► Subscribe | |||||||||||||||||||||||||||
| 6,576,250 | Pharmaceutical compositions for rectal and vaginal administration | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Spain | 2207295 | ► Subscribe | |||||||||||||||||||||||||||
| Portugal | 1115383 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 101184138 | ► Subscribe | |||||||||||||||||||||||||||
| Argentina | 048000 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 4478512 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2006000022 | Germany | ► Subscribe | PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126 | ||||||||||||||||||||||||||
| 2014000024 | Germany | ► Subscribe | PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831 | ||||||||||||||||||||||||||
| 00714 | Netherlands | ► Subscribe | PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718 | ||||||||||||||||||||||||||
| 00523 | Netherlands | ► Subscribe | PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006 | ||||||||||||||||||||||||||
| 0653 | Netherlands | ► Subscribe | PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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