FLOLAN Drug Patent Profile
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When do Flolan patents expire, and when can generic versions of Flolan launch?
Flolan is a drug marketed by Glaxosmithkline Llc and is included in one NDA.
The generic ingredient in FLOLAN is epoprostenol sodium. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the epoprostenol sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Flolan
A generic version of FLOLAN was approved as epoprostenol sodium by MEITHEAL on April 23rd, 2008.
Summary for FLOLAN
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 56 |
Clinical Trials: | 16 |
Patent Applications: | 3,953 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for FLOLAN |
What excipients (inactive ingredients) are in FLOLAN? | FLOLAN excipients list |
DailyMed Link: | FLOLAN at DailyMed |
Recent Clinical Trials for FLOLAN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University Health Network, Toronto | Phase 4 |
GlaxoSmithKline | Phase 4 |
Rune Rasmussen | Phase 2 |
Pharmacology for FLOLAN
Drug Class | Prostacycline Vasodilator |
Physiological Effect | Vasodilation |
Anatomical Therapeutic Chemical (ATC) Classes for FLOLAN
US Patents and Regulatory Information for FLOLAN
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Glaxosmithkline Llc | FLOLAN | epoprostenol sodium | INJECTABLE;INJECTION | 020444-002 | Sep 20, 1995 | AP1 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 FLOLAN
International Patents for FLOLAN
See the table below for patents covering FLOLAN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
France | 2359125 | NOUVEAUX DERIVES DE PROSTAGLANDINE, LEUR PROCEDE DE PREPARATION ET MEDICAMENT LES CONTENANT | ⤷ Try a Trial |
Australia | 2112577 | ⤷ Try a Trial | |
France | 2401919 | ⤷ Try a Trial | |
Ireland | 48231 | PHARMACEUTICAL FORMULATIONS CONTAINING PROSTAGLANDIN COMPOUNDS | ⤷ Try a Trial |
Mexico | 4811 | ⤷ Try a Trial | |
Ireland | 46036 | PROSTACYCLIN AND DERIVATIVES THEREOF | ⤷ Try a Trial |
Austria | A333177 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |