ILOPROST - Generic Drug Details

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What are the generic drug sources for iloprost and what is the scope of patent protection?

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. Two suppliers are listed for this compound.

Summary for ILOPROST

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	98
Patent Applications:	7,223
What excipients (inactive ingredients) are in ILOPROST?	ILOPROST excipients list
DailyMed Link:	ILOPROST at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ILOPROST

Generic Entry Date for ILOPROST^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: TREATMENT OF SEVERE FROSTBITE IN ADULTS TO REDUCE THE RISK OF DIGIT AMPUTATIONS Dosage: SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ILOPROST

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

Sponsor	Phase
DiaMed GmbH	N/A
Peter Korsten	N/A
Charite University, Berlin, Germany	Phase 1/Phase 2

See all ILOPROST clinical trials

Pharmacology for ILOPROST

Drug Class	Prostacycline

Medical Subject Heading (MeSH) Categories for ILOPROST

Platelet Aggregation Inhibitors
Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for ILOPROST

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

US Patents and Regulatory Information for ILOPROST

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actelion	VENTAVIS	iloprost	SOLUTION;INHALATION	021779-003	Aug 7, 2009		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eicos Sci	AURLUMYN	iloprost	SOLUTION;INTRAVENOUS	217933-001	Feb 13, 2024		RX	Yes	Yes	⤷ 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

EU/EMA Drug Approvals for ILOPROST

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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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