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For drug patent information on drugs not available in Asia
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To update my knowledge in several markets
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To follow patent expirations for generic production purposes
— Pharmacist, Tunisia
For paragraph IV challenge research
— Pharmaceutical company, USA
To get reliable data on drug patent information
— CFO, Pharmaceuticals, Singapore
Generated: May 23, 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 twenty patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 9 |
| Patents: | 20 |
| 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 | 559 |
| 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 | 8,092,832 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Watson Labs | FENTANYL CITRATE | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 079075-001 | Jan 7, 2011 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-002 | Sep 25, 2006 | RX | Yes | No | 6,974,590 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Depomed Inc | LAZANDA | fentanyl citrate | SPRAY, METERED;NASAL | 022569-002 | Jun 30, 2011 | RX | Yes | Yes | 8,216,604 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-002 | Sep 25, 2006 | RX | Yes | No | 8,119,158 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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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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