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Details for New Drug Application (NDA): 021214
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NDA 021214 describes RESCULA, which is a drug marketed by Sucampo Pharma Llc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the RESCULA profile page.
The generic ingredient in RESCULA is unoprostone isopropyl. There are four drug master file entries for this compound. Additional details are available on the unoprostone isopropyl profile page.
The generic ingredient in RESCULA is unoprostone isopropyl. There are four drug master file entries for this compound. Additional details are available on the unoprostone isopropyl profile page.
Summary for 021214
| Tradename: | RESCULA |
| Applicant: | Sucampo Pharma Llc |
| Ingredient: | unoprostone isopropyl |
| Patents: | 1 |
Generic Entry Opportunity Date for 021214
Generic Entry Date for 021214*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION/DROPS;OPHTHALMIC |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Paragraph IV (Patent) Challenges for 021214
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| RESCULA | SOLUTION/DROPS;OPHTHALMIC | unoprostone isopropyl | 021214 | 2014-05-12 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.15% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
| Approval Date: | Aug 3, 2000 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Jul 9, 2021 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING OCULAR HYPERTENSION | ||||||||
| Patent: | Start Trial | Patent Expiration: | Jul 9, 2021 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | THE LONG TERM TREATMENT OF PROPHYLACTIC MANAGEMENT OF OCULAR HYPERTENSION AND GLAUCOMA | ||||||||
Expired US Patents for NDA 021214
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | Start Trial | Start Trial |
| Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | Start Trial | Start Trial |
| Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | Start Trial | Start Trial |
| Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | Start Trial | Start Trial |
| Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | Start Trial | Start Trial |
| Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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