FLUOROMETHOLONE - Generic Drug Details
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What are the generic sources for fluorometholone and what is the scope of freedom to operate?
Fluorometholone
is the generic ingredient in eight branded drugs marketed by Pharmacia And Upjohn, Allergan, Novartis, Amneal, Abbvie, and Harrow Eye, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.There are five drug master file entries for fluorometholone. Three suppliers are listed for this compound.
Summary for FLUOROMETHOLONE
| US Patents: | 0 |
| Tradenames: | 8 |
| Applicants: | 6 |
| NDAs: | 9 |
| Drug Master File Entries: | 5 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 67 |
| Clinical Trials: | 22 |
| Patent Applications: | 6,752 |
| Drug Prices: | Drug price trends for FLUOROMETHOLONE |
| What excipients (inactive ingredients) are in FLUOROMETHOLONE? | FLUOROMETHOLONE excipients list |
| DailyMed Link: | FLUOROMETHOLONE at DailyMed |
Recent Clinical Trials for FLUOROMETHOLONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Maastricht University Medical Center | Phase 4 |
| Navy Medical Center San Diego | Phase 4 |
| Benha University | Phase 1 |
Pharmacology for FLUOROMETHOLONE
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for FLUOROMETHOLONE
Anatomical Therapeutic Chemical (ATC) Classes for FLUOROMETHOLONE
US Patents and Regulatory Information for FLUOROMETHOLONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allergan | FML | fluorometholone | OINTMENT;OPHTHALMIC | 017760-001 | Sep 4, 1985 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abbvie | FML FORTE | fluorometholone | SUSPENSION/DROPS;OPHTHALMIC | 019216-001 | Apr 23, 1986 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | FLUOR-OP | fluorometholone | SUSPENSION/DROPS;OPHTHALMIC | 070185-001 | Feb 27, 1986 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abbvie | FML | fluorometholone | SUSPENSION/DROPS;OPHTHALMIC | 016851-002 | Jul 28, 1982 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Amneal | FLUOROMETHOLONE | fluorometholone | SUSPENSION/DROPS;OPHTHALMIC | 216348-001 | Jan 9, 2024 | AB | RX | 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 |
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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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