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Last Updated: April 20, 2024

Iloprost - Generic Drug Details


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What are the generic drug sources for iloprost and what is the scope of freedom to operate?

Iloprost is the generic ingredient in two branded drugs marketed by Actelion and Eicos Sci, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for iloprost. One supplier is listed for this compound.

Summary for iloprost
Recent Clinical Trials for iloprost

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Peter KorstenN/A
DiaMed GmbHN/A
Charite University, Berlin, GermanyPhase 1/Phase 2

See all iloprost clinical trials

Pharmacology for iloprost
Drug ClassProstacycline
Medical Subject Heading (MeSH) Categories for iloprost

US Patents and Regulatory Information for iloprost

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actelion VENTAVIS iloprost SOLUTION;INHALATION 021779-001 Dec 29, 2004 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eicos Sci AURLUMYN iloprost SOLUTION;INTRAVENOUS 217933-001 Feb 13, 2024 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actelion VENTAVIS iloprost SOLUTION;INHALATION 021779-002 Dec 8, 2005 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actelion VENTAVIS iloprost SOLUTION;INHALATION 021779-003 Aug 7, 2009 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

EU/EMA Drug Approvals for iloprost

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Bayer AG Ventavis iloprost EMEA/H/C/000474
Treatment of patients with primary pulmonary hypertension, classified as New York Heart Association functional class III, to improve exercise capacity and symptoms.
Authorised no no no 2003-09-15
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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