EPOPROSTENOL SODIUM - Generic Drug Details
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What are the generic drug sources for epoprostenol sodium and what is the scope of patent protection?
Epoprostenol sodium
is the generic ingredient in three branded drugs marketed by Meitheal, Sun Pharm, Glaxosmithkline Llc, and Actelion, and is included in four NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Epoprostenol sodium has nineteen patent family members in fifteen countries.
There are seven drug master file entries for epoprostenol sodium. Three suppliers are listed for this compound.
Summary for EPOPROSTENOL SODIUM
International Patents: | 19 |
US Patents: | 2 |
Tradenames: | 3 |
Applicants: | 4 |
NDAs: | 4 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 42 |
Clinical Trials: | 7 |
Patent Applications: | 1,491 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EPOPROSTENOL SODIUM |
What excipients (inactive ingredients) are in EPOPROSTENOL SODIUM? | EPOPROSTENOL SODIUM excipients list |
DailyMed Link: | EPOPROSTENOL SODIUM at DailyMed |
Recent Clinical Trials for EPOPROSTENOL SODIUM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
GlaxoSmithKline | Phase 4 |
Actelion | Phase 4 |
United Therapeutics | Phase 4 |
Pharmacology for EPOPROSTENOL SODIUM
Drug Class | Prostacycline Vasodilator |
Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for EPOPROSTENOL SODIUM
Anatomical Therapeutic Chemical (ATC) Classes for EPOPROSTENOL SODIUM
Paragraph IV (Patent) Challenges for EPOPROSTENOL SODIUM
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
VELETRI | Injection | epoprostenol sodium | 0. 5m/vial and 1.5 mg/vial | 022260 | 1 | 2017-03-31 |
US Patents and Regulatory Information for EPOPROSTENOL SODIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxosmithkline Llc | FLOLAN | epoprostenol sodium | INJECTABLE;INJECTION | 020444-001 | Sep 20, 1995 | AP1 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Meitheal | EPOPROSTENOL SODIUM | epoprostenol sodium | INJECTABLE;INJECTION | 078396-002 | Apr 23, 2008 | AP1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Actelion | VELETRI | epoprostenol sodium | INJECTABLE;INJECTION | 022260-001 | Jun 27, 2008 | AP2 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 EPOPROSTENOL SODIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline Llc | FLOLAN | epoprostenol sodium | INJECTABLE;INJECTION | 020444-002 | Sep 20, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline Llc | FLOLAN | epoprostenol sodium | INJECTABLE;INJECTION | 020444-001 | Sep 20, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline Llc | FLOLAN | epoprostenol sodium | INJECTABLE;INJECTION | 020444-002 | Sep 20, 1995 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EPOPROSTENOL SODIUM
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Russian Federation | 2008135701 | КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ЭПОПРОСТЕНОЛ, И СПОСОБ ЕЕ ПОЛУЧЕНИЯ | ⤷ Sign Up |
Hungary | E026166 | ⤷ Sign Up | |
Portugal | 1993557 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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