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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

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.
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:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrength0.15% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 3, 2000TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jul 9, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING OCULAR HYPERTENSION
Patent:  Start TrialPatent Expiration:Jul 9, 2021Product 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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