FLUOROMETHOLONE Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Fluorometholone, and when can generic versions of Fluorometholone launch?
Fluorometholone is a drug marketed by Amneal and is included in one NDA.
The generic ingredient in FLUOROMETHOLONE is fluorometholone. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the fluorometholone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fluorometholone
A generic version of FLUOROMETHOLONE was approved as fluorometholone by AMNEAL on January 9th, 2024.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for FLUOROMETHOLONE?
- What are the global sales for FLUOROMETHOLONE?
- What is Average Wholesale Price for FLUOROMETHOLONE?
Summary for FLUOROMETHOLONE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 67 |
| Clinical Trials: | 22 |
| Patent Applications: | 4,310 |
| Drug Prices: | Drug price information 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
FLUOROMETHOLONE is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting FLUOROMETHOLONE
COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
