Fluorescein sodium - Generic Drug Details
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What are the generic drug sources for fluorescein sodium and what is the scope of patent protection?
Fluorescein sodium
is the generic ingredient in five branded drugs marketed by Novartis, Long Grove Pharms, Nexus Pharms, and Alcon Labs Inc, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.There are two drug master file entries for fluorescein sodium. Three suppliers are listed for this compound.
Summary for fluorescein sodium
| US Patents: | 0 |
| Tradenames: | 5 |
| Applicants: | 4 |
| NDAs: | 4 |
| Drug Master File Entries: | 2 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 41 |
| Clinical Trials: | 42 |
| Patent Applications: | 72 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in fluorescein sodium? | fluorescein sodium excipients list |
| DailyMed Link: | fluorescein sodium at DailyMed |
Recent Clinical Trials for fluorescein sodium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Early Phase 1 |
| Seoul National University Bundang Hospital | Phase 4 |
| Eximore Ltd. | Phase 1 |
Pharmacology for fluorescein sodium
| Drug Class | Diagnostic Dye |
| Mechanism of Action | Dyes |
Medical Subject Heading (MeSH) Categories for fluorescein sodium
Anatomical Therapeutic Chemical (ATC) Classes for fluorescein sodium
US Patents and Regulatory Information for fluorescein sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | FUNDUSCEIN-25 | fluorescein sodium | INJECTABLE;INJECTION | 017869-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Alcon Labs Inc | FLUORESCITE | fluorescein sodium | INJECTABLE;INTRAVENOUS | 021980-001 | Mar 28, 2006 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Long Grove Pharms | AK-FLUOR 10% | fluorescein sodium | INJECTABLE;INTRAVENOUS | 022186-001 | Aug 8, 2008 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Nexus Pharms | FLUORESCEIN SODIUM | fluorescein sodium | INJECTABLE;INTRAVENOUS | 215709-001 | Sep 25, 2023 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
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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 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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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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