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Prednisolone acetate - Generic Drug Details
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This ingredient has forty-four patent family members in fourteen countries.
There are eighty-two drug master file entries for prednisolone acetate. Six suppliers are listed for this compound.
Summary for Generic Name: prednisolone acetate
| Tradenames: | 18 |
| Patents: | 5 |
| Applicants: | 12 |
| NDAs: | 27 |
| Drug Master File Entries: see list | 82 |
| Suppliers / Packaging: see list | 6 |
| Therapeutic Class: | Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal) Inflammatory Bowel Disease Agents Ophthalmic Agents |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: prednisolone acetate
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Clinical Trials for: prednisolone acetate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Akorn | PREDNISOLONE ACETATE | prednisolone acetate | INJECTABLE;INJECTION | 084492-001 | Approved Prior to Jan 1, 1982 | DISCN | No | ||||||||||||||||||||||
Allergan | BLEPHAMIDE | prednisolone acetate; sulfacetamide sodium | SUSPENSION;OPHTHALMIC | 012813-002 | Approved Prior to Jan 1, 1982 | RX | Yes | ||||||||||||||||||||||
Taro | FLO-PRED | prednisolone acetate | SUSPENSION;ORAL | 022067-001 | Jan 17, 2008 | DISCN | No | 7,799,331 | Oct 11, 2028 | Y | |||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: prednisolone acetate
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Taro | FLO-PRED | prednisolone acetate | SUSPENSION;ORAL | 022067-001 | Jan 17, 2008 | 5,881,926 | <disabled> | ||||||||||||||||||||||
Taro | FLO-PRED | prednisolone acetate | SUSPENSION;ORAL | 022067-001 | Jan 17, 2008 | 6,102,254 | <disabled> | ||||||||||||||||||||||
Taro | FLO-PRED | prednisolone acetate | SUSPENSION;ORAL | 022067-002 | Jan 17, 2008 | 6,102,254 | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Generic Ingredient: prednisolone acetate
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,461,139 | Oral suspension of prednisolone acetate | <disabled in preview> | |||||||||||||||||||||||||||
| 6,102,254 | Pharmaceutical compositions in semisolid form and a device for administration thereof | <disabled in preview> | |||||||||||||||||||||||||||
| 6,355,258 | Method for formulating spill resistant pharmaceutical compositions in semi-solid form | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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International Patent Family for Ingredient: prednisolone acetate
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Germany | 69939792 | <disabled in preview> | |||||||||||||||||||||||||||
| European Patent Office | 2008649 | <disabled in preview> | |||||||||||||||||||||||||||
| Australia | 2006278620 | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
Export unavailable in trial.
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