PREDNISOLONE Drug Patent Profile
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When do Prednisolone patents expire, and what generic alternatives are available?
Prednisolone is a drug marketed by Chartwell Rx, Hikma, Ivax Sub Teva Pharms, Lannett Co Inc, Nesher Pharms, Pharm Assoc, Pharmobedient Cnsltg, Teva Pharms, We Pharms, Aurobindo Pharma Ltd, Barr, Bundy, Chartwell Molecular, Elkins Sinn, Everylife, Ferrante, Fosun Pharma, Heather, Impax Labs, Inwood Labs, Marshall Pharma, Panray, Phoenix Labs Ny, Purepac Pharm, Pvt Form, Rising, Roxane, Sperti, Superpharm, Tablicaps, Teva, UDL, Valeant Pharm Intl, Vitarine, Watson Labs, West Ward, Whiteworth Town Plsn, Bel Mar, Cent Pharms, Epic Pharma Llc, Alcon Pharms Ltd, Bausch And Lomb, Sola Barnes Hind, Amneal, Amneal Pharms, Bausch, Edenbridge Pharms, Mission Pharma, Vintage, Vintage Pharms, and Xttrium Labs Inc. and is included in eighty-five NDAs.
The generic ingredient in PREDNISOLONE is prednisolone tebutate. There are eighty-eight drug master file entries for this compound. Additional details are available on the prednisolone tebutate profile page.
Summary for PREDNISOLONE
See drug prices for PREDNISOLONE
Recent Clinical Trials for PREDNISOLONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Maastricht University Medical Center | Phase 2 |
| Erasmus Medical Center | Phase 2 |
| Academisch Ziekenhuis Groningen | Phase 2 |
Pharmacology for PREDNISOLONE
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for PREDNISOLONE
Anatomical Therapeutic Chemical (ATC) Classes for PREDNISOLONE
US Patents and Regulatory Information for PREDNISOLONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sola Barnes Hind | PREDNISOLONE SODIUM PHOSPHATE | prednisolone sodium phosphate | SOLUTION/DROPS;OPHTHALMIC | 084169-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Tablicaps | PREDNISOLONE | prednisolone | TABLET;ORAL | 085170-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Phoenix Labs Ny | PREDNISOLONE | prednisolone | TABLET;ORAL | 080322-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pharm Assoc | PREDNISOLONE SODIUM PHOSPHATE | prednisolone sodium phosphate | SOLUTION;ORAL | 076123-001 | Dec 23, 2002 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Watson Labs | PREDNISOLONE | prednisolone | TABLET;ORAL | 085416-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Watson Labs | PREDNISOLONE ACETATE | prednisolone acetate | INJECTABLE;INJECTION | 083767-001 | Approved Prior to Jan 1, 1982 | DISCN | 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 |
EU/EMA Drug Approvals for PREDNISOLONE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| LE VET B.V. | Equisolon | Prednisolone | EMEA/V/C/002382 Alleviation of inflammatory and clinical parameters associated with recurrent airway obstruction (RAO) in horses, in combination with environmental control. |
Authorised | no | no | no | 2014-03-12 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
