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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Fuji
Farmers Insurance
Cantor Fitzgerald
Merck
Teva
Covington
Mallinckrodt
UBS
Chinese Patent Office

Generated: August 20, 2017

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. It is available from one supplier. There are two patents 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. One supplier is listed for this compound. Additional details are available on the unoprostone isopropyl profile page.

Summary for NDA: 021214

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:2

Pharmacology for NDA: 021214

Ingredient-typeProstaglandins

Suppliers and Packaging for NDA: 021214

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RESCULA
unoprostone isopropyl
SOLUTION/DROPS;OPHTHALMIC 021214 NDA Sucampo Pharma Americas, LLC 17350-015 17350-015-05 5 mL in 1 BOTTLE, DROPPER (17350-015-05)

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:► SubscribePatent Expiration:Nov 24, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF REDUCING OCULAR HYPERTENSION
Patent:► SubscribePatent Expiration:Jul 9, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING OCULAR HYPERTENSION
Patent:► SubscribePatent Expiration:Jul 9, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:THE LONG TERM TREATMENT OF PROPHYLACTIC MANAGEMENT OF OCULAR HYPERTENSION AND GLAUCOMA

Expired Orange Book Patents for NDA: 021214

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sucampo Pharma Llc
RESCULA
unoprostone isopropyl
SOLUTION/DROPS;OPHTHALMIC021214-001Aug 3, 2000► Subscribe► Subscribe
Sucampo Pharma Llc
RESCULA
unoprostone isopropyl
SOLUTION/DROPS;OPHTHALMIC021214-001Aug 3, 2000► Subscribe► Subscribe
Sucampo Pharma Llc
RESCULA
unoprostone isopropyl
SOLUTION/DROPS;OPHTHALMIC021214-001Aug 3, 2000► Subscribe► Subscribe
Sucampo Pharma Llc
RESCULA
unoprostone isopropyl
SOLUTION/DROPS;OPHTHALMIC021214-001Aug 3, 2000► Subscribe► Subscribe
Sucampo Pharma Llc
RESCULA
unoprostone isopropyl
SOLUTION/DROPS;OPHTHALMIC021214-001Aug 3, 2000► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Healthtrust
Daiichi Sankyo
Colorcon
Cerilliant
QuintilesIMS
Boehringer Ingelheim
Farmers Insurance
Moodys
Mallinckrodt
US Department of Justice

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 verifification 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.

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