PREDNISOLONE ACETATE Drug Patent Profile
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When do Prednisolone Acetate patents expire, and when can generic versions of Prednisolone Acetate launch?
Prednisolone Acetate is a drug marketed by Bel Mar, Cent Pharms, Epic Pharma Llc, Watson Labs, and Lupin Ltd. and is included in ten NDAs.
The generic ingredient in PREDNISOLONE ACETATE is prednisolone acetate. There are eighty-eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the prednisolone acetate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Prednisolone Acetate
A generic version of PREDNISOLONE ACETATE was approved as prednisolone acetate by LUPIN LTD on August 2nd, 2024.
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Summary for PREDNISOLONE ACETATE
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 10 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 74 |
| Clinical Trials: | 106 |
| Patent Applications: | 4,205 |
| Drug Prices: | Drug price information for PREDNISOLONE ACETATE |
| Drug Sales Revenues: | Drug sales revenues for PREDNISOLONE ACETATE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PREDNISOLONE ACETATE |
| What excipients (inactive ingredients) are in PREDNISOLONE ACETATE? | PREDNISOLONE ACETATE excipients list |
| DailyMed Link: | PREDNISOLONE ACETATE at DailyMed |
See drug prices for PREDNISOLONE ACETATE
Recent Clinical Trials for PREDNISOLONE ACETATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Baoping XU | Phase 4 |
| Wyse Eyecare | Phase 4 |
| Salvat | Phase 3 |
Pharmacology for PREDNISOLONE ACETATE
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for PREDNISOLONE ACETATE
US Patents and Regulatory Information for PREDNISOLONE ACETATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bel Mar | PREDNISOLONE ACETATE | prednisolone acetate | INJECTABLE;INJECTION | 083738-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | PREDNISOLONE ACETATE | prednisolone acetate | INJECTABLE;INJECTION | 083398-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Cent Pharms | PREDNISOLONE ACETATE | prednisolone acetate | INJECTABLE;INJECTION | 084717-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Lupin Ltd | PREDNISOLONE ACETATE | prednisolone acetate | SUSPENSION/DROPS;OPHTHALMIC | 216935-001 | Aug 2, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Watson Labs | PREDNISOLONE ACETATE | prednisolone acetate | INJECTABLE;INJECTION | 083654-001 | Approved Prior to Jan 1, 1982 | 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 |
