FENTANYL CITRATE - Generic Drug Details
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What are the generic 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: | 106 |
Patent Applications: | 6,178 |
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 |
---|---|
Stichting ZiektekostenVerzekering Krijgsmacht | Phase 3 |
Ambulance Amsterdam | Phase 3 |
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Phase 3 |
Generic filers with tentative approvals for FENTANYL CITRATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 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 |
Anatomical Therapeutic Chemical (ATC) Classes for FENTANYL CITRATE
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 | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-001 | Nov 4, 1998 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Fresenius Kabi Usa | FENTANYL CITRATE PRESERVATIVE FREE | fentanyl citrate | INJECTABLE;INJECTION | 210762-001 | May 3, 2019 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Rising | SUBLIMAZE PRESERVATIVE FREE | fentanyl citrate | INJECTABLE;INJECTION | 016619-001 | Approved Prior to Jan 1, 1982 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Dr Reddys Labs Sa | FENTANYL CITRATE | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 206329-003 | Aug 22, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Watson Labs | FENTANYL CITRATE | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 079075-001 | Jan 7, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Btcp Pharma | LAZANDA | fentanyl citrate | SPRAY, METERED;NASAL | 022569-001 | Jun 30, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 |
---|---|---|---|---|---|---|---|
Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-005 | Sep 25, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-002 | Jan 7, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Adalvo | ONSOLIS | fentanyl citrate | FILM;BUCCAL | 022266-002 | Jul 16, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-004 | Jan 7, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-001 | Jan 7, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Sentynl Theraps Inc | ABSTRAL | fentanyl citrate | TABLET;SUBLINGUAL | 022510-003 | Jan 7, 2011 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FENTANYL CITRATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | 122020000250 | dispositivos para administração de fármaco | ⤷ Sign Up |
China | 1723012 | Pharmaceutical compositions comprising fentanyl for intranasal delivery | ⤷ Sign Up |
Poland | 212950 | ⤷ Sign Up | |
Japan | 2013151549 | TRANSMUCOSAL DELIVERY DEVICE WITH ENHANCED UPTAKE | ⤷ Sign Up |
Japan | 2009544619 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2008011194 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FENTANYL CITRATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0836511 | 122006000022 | Germany | ⤷ Sign Up | PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126 |
1635783 | 122014000024 | Germany | ⤷ Sign Up | PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831 |
1635783 | 132014902242643 | Italy | ⤷ Sign Up | 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 |
0975367 | 122011000009 | Germany | ⤷ Sign Up | PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831 |
0836511 | SPC/GB06/022 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124 |
1635783 | C300653 | Netherlands | ⤷ Sign Up | 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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