Prednisolone acetate - Generic Drug Details
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What are the generic sources for prednisolone acetate and what is the scope of patent protection?
Prednisolone acetate
is the generic ingredient in eighteen branded drugs marketed by Schering, Bel Mar, Cent Pharms, Epic Pharma Llc, Watson Labs, Pfizer, Harrow Eye, Sandoz, Abbvie, Taro, Allergan, Alcon, Pharmafair, Novartis, and Bausch And Lomb, and is included in twenty-seven NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Prednisolone acetate has eleven patent family members in nine countries.
There are eighteen drug master file entries for prednisolone acetate. Seven suppliers are listed for this compound.
Summary for prednisolone acetate
| International Patents: | 11 |
| US Patents: | 1 |
| Tradenames: | 18 |
| Applicants: | 15 |
| NDAs: | 27 |
| Drug Master File Entries: | 18 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 74 |
| Clinical Trials: | 105 |
| Patent Applications: | 6,205 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends 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 |
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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer | STERANE | prednisolone acetate | INJECTABLE;INJECTION | 011446-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | VASOCIDIN | prednisolone acetate; sulfacetamide sodium | OINTMENT;OPHTHALMIC | 088791-001 | Oct 5, 1984 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Alcon | ISOPTO CETAPRED | prednisolone acetate; sulfacetamide sodium | SUSPENSION;OPHTHALMIC | 087547-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Epic Pharma Llc | PREDAMIDE | prednisolone acetate; sulfacetamide sodium | SUSPENSION/DROPS;OPHTHALMIC | 088059-001 | Jul 29, 1983 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pharmafair | PREDSULFAIR | prednisolone acetate; sulfacetamide sodium | OINTMENT;OPHTHALMIC | 088032-001 | Apr 15, 1983 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bel Mar | PREDNISOLONE ACETATE | prednisolone acetate | INJECTABLE;INJECTION | 083738-001 | 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 |
Expired US Patents for prednisolone acetate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Taro | FLO-PRED | prednisolone acetate | SUSPENSION;ORAL | 022067-001 | Jan 17, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Taro | FLO-PRED | prednisolone acetate | SUSPENSION;ORAL | 022067-001 | Jan 17, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Taro | FLO-PRED | prednisolone acetate | SUSPENSION;ORAL | 022067-001 | Jan 17, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Taro | FLO-PRED | prednisolone acetate | SUSPENSION;ORAL | 022067-001 | Jan 17, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Taro | FLO-PRED | prednisolone acetate | SUSPENSION;ORAL | 022067-002 | Jan 17, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Taro | FLO-PRED | prednisolone acetate | SUSPENSION;ORAL | 022067-002 | Jan 17, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for prednisolone acetate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 101247786 | Oral suspension of prednisolone acetate | ⤷ Try a Trial |
| South Korea | 20080044245 | ORAL SUSPENSION OF PREDNISOLONE ACETATE | ⤷ Try a Trial |
| European Patent Office | 1909798 | SUSPENSION ORALE D'ACETATE DE PREDNISOLONE (ORAL SUSPENSION OF PREDNISOLONE ACETATE) | ⤷ Try a Trial |
| Japan | 2009503097 | ⤷ Try a Trial | |
| European Patent Office | 2630951 | Suspension orale d'acétate de prednisolone (Oral suspension of prednisolone acetate) | ⤷ Try a Trial |
| Australia | 2006278620 | Oral suspension of prednisolone acetate | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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