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Last Updated: April 26, 2024

FLOLAN Drug Patent Profile


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Which patents cover Flolan, 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.

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Drug patent expirations by year for FLOLAN
Drug Prices for FLOLAN

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Recent Clinical Trials for FLOLAN

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SponsorPhase
University Health Network, TorontoPhase 4
GlaxoSmithKlinePhase 4
Rune RasmussenPhase 2

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Pharmacology for FLOLAN
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation

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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-002 Sep 20, 1995 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-001 Sep 20, 1995 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-001 Sep 20, 1995 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-001 Sep 20, 1995 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-002 Sep 20, 1995 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-002 Sep 20, 1995 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-002 Sep 20, 1995 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

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