PREDNISOLONE ACETATE - Generic Drug Details
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What are the generic drug sources for prednisolone acetate and what is the scope of freedom to operate?
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, Lupin Ltd, Taro, Allergan, Alcon, Pharmafair, Novartis, and Bausch And Lomb, and is included in twenty-eight 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. Nine suppliers are listed for this compound.
Summary for PREDNISOLONE ACETATE
International Patents: | 11 |
US Patents: | 1 |
Tradenames: | 18 |
Applicants: | 16 |
NDAs: | 28 |
Drug Master File Entries: | 18 |
Finished Product Suppliers / Packagers: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 74 |
Clinical Trials: | 106 |
Patent Applications: | 6,160 |
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 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Harrow Eye | ECONOPRED | prednisolone acetate | SUSPENSION/DROPS;OPHTHALMIC | 017468-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Abbvie | PRED FORTE | prednisolone acetate | SUSPENSION/DROPS;OPHTHALMIC | 017011-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Allergan | BLEPHAMIDE | prednisolone acetate; sulfacetamide sodium | SUSPENSION;OPHTHALMIC | 012813-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Allergan | BLEPHAMIDE S.O.P. | prednisolone acetate; sulfacetamide sodium | OINTMENT;OPHTHALMIC | 087748-001 | Dec 3, 1986 | DISCN | 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 |
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 | ⤷ Sign Up | ⤷ Sign Up |
Taro | FLO-PRED | prednisolone acetate | SUSPENSION;ORAL | 022067-002 | Jan 17, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Taro | FLO-PRED | prednisolone acetate | SUSPENSION;ORAL | 022067-001 | Jan 17, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Taro | FLO-PRED | prednisolone acetate | SUSPENSION;ORAL | 022067-002 | Jan 17, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Taro | FLO-PRED | prednisolone acetate | SUSPENSION;ORAL | 022067-002 | Jan 17, 2008 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PREDNISOLONE ACETATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Africa | 200800926 | ORAL SUSPENSION OF PREDNISOLONE ACETATE | ⤷ Sign Up |
Japan | 2013014634 | ORAL SUSPENSION OF PREDNISOLONE ACETATE | ⤷ Sign Up |
New Zealand | 566117 | Oral suspension of prednisolone acetate | ⤷ Sign Up |
Japan | 2009503097 | ⤷ Sign Up | |
European Patent Office | 2630951 | Suspension orale d'acétate de prednisolone (Oral suspension of prednisolone acetate) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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