➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Dow
Johnson and Johnson
Baxter
Mallinckrodt

Last Updated: July 3, 2020

DrugPatentWatch Database Preview

UNOPROSTONE ISOPROPYL - Generic Drug Details

» See Plans and Pricing

« Back to Dashboard

What are the generic sources for unoprostone isopropyl and what is the scope of freedom to operate?

Unoprostone isopropyl is the generic ingredient in one branded drug marketed by Sucampo Pharma Llc and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Unoprostone isopropyl has twenty-one patent family members in eighteen countries.

There are four drug master file entries for unoprostone isopropyl.

Summary for UNOPROSTONE ISOPROPYL
International Patents:21
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 4
Bulk Api Vendors: 17
Clinical Trials: 1
Patent Applications: 790
DailyMed Link:UNOPROSTONE ISOPROPYL at DailyMed
Recent Clinical Trials for UNOPROSTONE ISOPROPYL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Sucampo Pharmaceuticals, Inc.Phase 2

See all UNOPROSTONE ISOPROPYL clinical trials

Paragraph IV (Patent) Challenges for UNOPROSTONE ISOPROPYL
Tradename Dosage Ingredient NDA Submissiondate
RESCULA SOLUTION/DROPS;OPHTHALMIC unoprostone isopropyl 021214 2014-05-12

US Patents and Regulatory Information for UNOPROSTONE ISOPROPYL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sucampo Pharma Llc RESCULA unoprostone isopropyl SOLUTION/DROPS;OPHTHALMIC 021214-001 Aug 3, 2000 DISCN Yes No   Start Trial   Start Trial   Start Trial
>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 UNOPROSTONE ISOPROPYL

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

Supplementary Protection Certificates for UNOPROSTONE ISOPROPYL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0289349 C300135 Netherlands   Start Trial PRODUCT NAME: UNOPROSTONEZUUR, DESGEWENST IN DE VORM VAN EEN ESTER OF EEN ZOUT; NATL REGISTRATION NO/DATE: RVG 28628 20030708; FIRST REGISTRATION: FR 359 911-5 AND 359 912-1 20020917
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Dow
Johnson and Johnson
Baxter
Mallinckrodt

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 verification 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.