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Fentanyl citrate - Generic Drug Details
What are the generic drug 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 Bdsi, Abbott, Hospira, Watson Labs, Watson Labs Inc, West-ward Pharms Int, Akorn, Elefsee Pharms Intl, Cephalon, Sentynl Theraps Inc, Actavis Labs Fl Inc, Par Pharm, and Specgx Llc, and is included in eighteen NDAs. There are twenty patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Fentanyl citrate has three hundred and fifty-seven patent family members in forty-one countries.
There are thirty-one drug master file entries for fentanyl citrate. Thirteen suppliers are listed for this compound.
Summary for fentanyl citrate
| International Patents: | 357 |
| US Patents: | 20 |
| Tradenames: | 9 |
| Applicants: | 13 |
| NDAs: | 18 |
| Drug Master File Entries: | 31 |
| Suppliers / Packagers: | 13 |
| Bulk Api Vendors: | 27 |
| Clinical Trials: | 63 |
| Patent Applications: | 3,092 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for fentanyl citrate |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for fentanyl citrate |
| DailyMed Link: | fentanyl citrate at DailyMed |
Pharmacology for fentanyl citrate
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
Synonyms for fentanyl citrate
| 2-hydroxypropane-1,2,3-tricarboxylic acid; N-(1-phenethylpiperidin-4-yl)-N-phenylpropanamide |
| 437-38-7 (Parent) |
| 990-73-8 |
| 990F738 |
| Abstral (TN) |
| AC1L22J8 |
| AC1Q5SOC |
| AKOS024457504 |
| AN-48204 |
| API0002694 |
| B5403 |
| CHEBI:31602 |
| CHEMBL688 |
| CITRIC ACID; FENTANYL |
| citric acid; N-phenyl-N-[1-(2-phenylethyl)-4-piperidyl]propanamide |
| D01399 |
| DTXSID80243933 |
| EINECS 213-588-0 |
| Fentanyl citrate (JP17/USP) |
| Fentanyl citrate [USAN:JAN] |
| Fentanyl citrate [USAN:USP:BAN:JAN] |
| FENTANYL CITRATE PRESERVATIVE FREE |
| Fentanyl citrate salt |
| Fentanyl citrate salt solution, drug standard, 100 mug/mL in methanol: tert-butanol (3:2) |
| Fentanyl citrate, United States Pharmacopeia (USP) Reference Standard |
| Fentanyl dihydrogen citrate |
| fentanyl monocitrate |
| Fentanylcitrate |
| Fentaz |
| Fentora (TN) |
| FT-0668509 |
| HE071150 |
| IVLVTNPOHDFFCJ-UHFFFAOYSA-N |
| Lazanda (TN) |
| Leptanol |
| LS-124441 |
| McN-JR 4263 |
| McN-JR-4263-49 |
| MFCD00058359 |
| MUN5LYG46H |
| N-(1-Phenethyl-4-piperidinyl)propionanilide dihydrogen citrate |
| N-(1-Phenethyl-4-piperidyl)propionanilide citrate |
| N-(1-Phenethyl-4-piperidyl)propionanilide citrate (1:1) |
| N-(1-Phenethyl-4-piperidyl)propionanilide dihydrogen citrate |
| N-(1-phenethylpiperidin-4-yl)-N-phenylpropionamide citrate |
| N-(Phenyl)-N-(1-[2-phenylethyl]-4-piperidinyl)propanamide Citrate |
| N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]propanamide citrate |
| N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]propanamide citrate salt |
| N-phenyl-N-[1-(2-phenylethyl)-4-piperidyl]propanamide citrate |
| N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]propanamide 2-hydroxypropane-1,2,3-tricarboxylate |
| Oralet |
| Oralet (TN) |
| Oravescent |
| Phentanyl citrate |
| Propanamide, N-phenyl-N-(1-(2-phenylethyl)-4-piperidinyl)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1) |
| Propionanilide, N-(1-phenethyl-4-piperidyl)-, citrate (1:1) |
| R 5240 |
| SCHEMBL40733 |
| SUBLIMAZE PRESERVATIVE FREE |
| UNII-MUN5LYG46H |
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 | 021947-002 | Sep 25, 2006 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-005 | Jan 7, 2011 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Bdsi | ONSOLIS | fentanyl citrate | FILM;BUCCAL | 022266-003 | Jul 16, 2009 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Actavis Labs Fl Inc | FENTANYL CITRATE | fentanyl citrate | TABLET;SUBLINGUAL | 207338-006 | Nov 17, 2017 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Par Pharm | FENTANYL CITRATE | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 077312-005 | Oct 30, 2009 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Elefsee Pharms Intl | LAZANDA | fentanyl citrate | SPRAY, METERED;NASAL | 022569-001 | Jun 30, 2011 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-002 | Sep 25, 2006 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| 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 |
|---|---|---|---|---|---|---|---|
| Elefsee Pharms Intl | LAZANDA | fentanyl citrate | SPRAY, METERED;NASAL | 022569-002 | Jun 30, 2011 | ➤ Sign Up | ➤ Sign Up |
| Bdsi | ONSOLIS | fentanyl citrate | FILM;BUCCAL | 022266-004 | Jul 16, 2009 | ➤ Sign Up | ➤ Sign Up |
| Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-003 | Nov 4, 1998 | ➤ Sign Up | ➤ Sign Up |
| Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-004 | Nov 4, 1998 | ➤ Sign Up | ➤ Sign Up |
| Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-003 | Nov 4, 1998 | ➤ Sign Up | ➤ Sign Up |
| Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-006 | Nov 4, 1998 | ➤ Sign Up | ➤ Sign Up |
| Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-003 | Nov 4, 1998 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for fentanyl citrate
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2009106177 | ➤ Sign Up |
| Norway | 20063429 | ➤ Sign Up |
| South Korea | 20120102121 | ➤ Sign Up |
| Japan | 2014511307 | ➤ Sign Up |
| Israel | 176449 | ➤ Sign Up |
| Czech Republic | 302975 | ➤ Sign Up |
| New Zealand | 613309 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for fentanyl citrate
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 00653 | Netherlands | ➤ Sign Up | PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906 |
| C/GB06/022 | United Kingdom | ➤ Sign Up | PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124 |
| 00714 | Netherlands | ➤ Sign Up | PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718 |
| 00523 | Netherlands | ➤ Sign Up | PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006 |
| 0653 | Netherlands | ➤ Sign Up | PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906 |
| 2006000022 | Germany | ➤ Sign Up | PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126 |
| 4 | Finland | ➤ Sign Up | |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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