Unoprostone isopropyl - Generic Drug Details
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What are the generic 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. Additional information is available in the individual branded drug profile pages.There are three drug master file entries for unoprostone isopropyl.
Summary for unoprostone isopropyl
US Patents: | 0 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 34 |
Clinical Trials: | 1 |
Patent Applications: | 2,098 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for unoprostone isopropyl |
DailyMed Link: | unoprostone isopropyl at DailyMed |
Recent Clinical Trials for unoprostone isopropyl
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sucampo Pharma Americas, LLC | Phase 2 |
Sucampo Pharmaceuticals, Inc. | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for unoprostone isopropyl
Paragraph IV (Patent) Challenges for UNOPROSTONE ISOPROPYL
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
RESCULA | Ophthalmic Solution | unoprostone isopropyl | 0.15% | 021214 | 1 | 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Sucampo Pharma Llc | RESCULA | unoprostone isopropyl | SOLUTION/DROPS;OPHTHALMIC | 021214-001 | Aug 3, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |