Fentanyl citrate - Generic Drug Details
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What are the generic drug sources for fentanyl citrate and what is the scope of patent protection?
Fentanyl citrate
is the generic ingredient in nine branded drugs marketed by Adalvo, Abbott, Fresenius Kabi Usa, Hikma, Hospira, Watson Labs, Dr Reddys, Rising, Exela Pharma, Btcp Pharma, Dr Reddys Labs Sa, Cephalon, Sentynl Theraps Inc, Actavis Labs Fl Inc, Par Pharm, and Specgx Llc, and is included in twenty-two NDAs. There are ten patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Fentanyl citrate has one hundred and seventy-two patent family members in thirty-five countries.
There are fifteen drug master file entries for fentanyl citrate. Ten suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for fentanyl citrate
| International Patents: | 172 |
| US Patents: | 10 |
| Tradenames: | 9 |
| Applicants: | 16 |
| NDAs: | 22 |
| Drug Master File Entries: | 15 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 39 |
| Clinical Trials: | 105 |
| Patent Applications: | 6,596 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for fentanyl citrate |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for fentanyl citrate |
| What excipients (inactive ingredients) are in fentanyl citrate? | fentanyl citrate excipients list |
| DailyMed Link: | fentanyl citrate at DailyMed |
Recent Clinical Trials for fentanyl citrate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of British Columbia | Phase 4 |
| Chung-Ang University Gwangmyeong Hospital | N/A |
| Ciusss de L'Est de l'Île de Montréal | N/A |
Generic filers with tentative approvals for FENTANYL CITRATE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try a Trial | ⤷ Try a Trial | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION |
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 citrate
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
Paragraph IV (Patent) Challenges for FENTANYL CITRATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ABSTRAL | Sublingual Tablets | fentanyl citrate | 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg | 022510 | 1 | 2014-06-19 |
| FENTORA | Buccal Tablets | fentanyl citrate | 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg | 021947 | 1 | 2007-11-13 |
| ACTIQ | Lozenges | fentanyl citrate | 0.6 mg | 020747 | 2004-12-20 | |
| ACTIQ | Lozenges | fentanyl citrate | 0.8 mg, 1.2 mg and 1.6 mg | 020747 | 2004-11-22 | |
| ACTIQ | Lozenges | fentanyl citrate | 0.2 mg | 020747 | 2004-10-29 | |
| ACTIQ | Lozenges | fentanyl citrate | 0.4 mg | 020747 | 2004-10-06 |
US Patents and Regulatory Information for fentanyl citrate
| 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 | 021947-005 | Sep 25, 2006 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-002 | Jan 7, 2011 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-002 | Sep 25, 2006 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 citrate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-002 | Nov 4, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-001 | Sep 25, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Adalvo | ONSOLIS | fentanyl citrate | FILM;BUCCAL | 022266-002 | Jul 16, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for fentanyl citrate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 103339034 | Improved container | ⤷ Try a Trial |
| Norway | 338714 | ⤷ Try a Trial | |
| Poland | 1708686 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for fentanyl citrate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1635783 | 132014902242643 | Italy | ⤷ Try a Trial | PRODUCT NAME: FENTANIL IN QUALSIASI FORMA PROTETTA DAL BREVETTO DI BASE(PECFENT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/10/644/001-004, 20100831 |
| 0836511 | SPC/GB06/022 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124 |
| 1769785 | C300522 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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