FENTANYL CITRATE Drug Patent Profile
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Which patents cover Fentanyl Citrate, and when can generic versions of Fentanyl Citrate launch?
Fentanyl Citrate is a drug marketed by Abbott, Fresenius Kabi Usa, Hikma, Hospira, Watson Labs, Exela Pharma, Dr Reddys Labs Sa, Actavis Labs Fl Inc, Par Pharm, Specgx Llc, Astrazeneca, and Dr Reddys. and is included in nineteen NDAs.
The generic ingredient in FENTANYL CITRATE is droperidol; fentanyl citrate. There are five drug master file entries for this compound. Additional details are available on the droperidol; fentanyl citrate profile page.
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Summary for FENTANYL CITRATE
| US Patents: | 0 |
| Applicants: | 12 |
| NDAs: | 19 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 39 |
| Clinical Trials: | 106 |
| Patent Applications: | 3,927 |
| Drug Prices: | Drug price information 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 |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Phase 3 |
| Stichting ZiektekostenVerzekering Krijgsmacht | Phase 3 |
| Ambulance Amsterdam | Phase 3 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca | FENTANYL CITRATE AND DROPERIDOL | droperidol; fentanyl citrate | INJECTABLE;INJECTION | 072028-001 | Apr 13, 1989 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Par Pharm | FENTANYL CITRATE | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 077312-006 | Oct 30, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira | FENTANYL CITRATE PRESERVATIVE FREE | fentanyl citrate | INJECTABLE;INJECTION | 072786-001 | Sep 24, 1991 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Par Pharm | FENTANYL CITRATE | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 077312-002 | Oct 30, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Specgx Llc | FENTANYL CITRATE | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 078907-001 | Oct 30, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Par Pharm | FENTANYL CITRATE | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 077312-003 | Oct 30, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abbott | FENTANYL CITRATE | fentanyl citrate | INJECTABLE;INJECTION | 070636-001 | Apr 30, 1990 | DISCN | No | 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 |
