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Last Updated: September 27, 2021

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UNOPROSTONE ISOPROPYL - Generic Drug Details

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What are the generic drug sources for unoprostone isopropyl and what is the scope of patent protection?

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
Raw Ingredient (Bulk) Api Vendors: 24
Clinical Trials: 1
Patent Applications: 2,347
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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Sucampo Pharma Llc RESCULA unoprostone isopropyl SOLUTION/DROPS;OPHTHALMIC 021214-001 Aug 3, 2000 ⤷  Try it Free ⤷  Try it Free
Sucampo Pharma Llc RESCULA unoprostone isopropyl SOLUTION/DROPS;OPHTHALMIC 021214-001 Aug 3, 2000 ⤷  Try it Free ⤷  Try it Free
Sucampo Pharma Llc RESCULA unoprostone isopropyl SOLUTION/DROPS;OPHTHALMIC 021214-001 Aug 3, 2000 ⤷  Try it Free ⤷  Try it Free
Sucampo Pharma Llc RESCULA unoprostone isopropyl SOLUTION/DROPS;OPHTHALMIC 021214-001 Aug 3, 2000 ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free 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

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Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Boehringer Ingelheim
Express Scripts
Harvard Business School
McKesson

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