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ENJUVIA Drug Profile

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When do Enjuvia patents expire, and what generic alternatives are available?

Enjuvia is a drug marketed by Aspen and is included in one NDA. There are two patents protecting this drug.

This drug has seventeen patent family members in nine countries.

The generic ingredient in ENJUVIA is estrogens, conjugated synthetic b. There are three drug master file entries for this compound. Additional details are available on the estrogens, conjugated synthetic b profile page.

US ANDA Litigation and Generic Entry Outlook for Enjuvia

Enjuvia was eligible for patent challenges on December 31^st, 1968.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 8^th, 2021. This may change due to patent challenges or generic licensing.

Summary for ENJUVIA

International Patents:	17
US Patents:	2
Applicants:	1
NDAs:	1
Clinical Trials:	2
Formulation / Manufacturing:	see details
DailyMed Link:	ENJUVIA at DailyMed

See drug sales revenues for ENJUVIA

Generic Entry Opportunity Date for ENJUVIA

NDA:

021443

Dosage:

TABLET;ORAL

^*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 ENJUVIA

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

Sponsor	Phase
Duramed Research	Phase 4
Duramed Research	Phase 3

See all ENJUVIA clinical trials

US Patents and Regulatory Information for ENJUVIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aspen	ENJUVIA	estrogens, conjugated synthetic b	TABLET;ORAL	021443-001	Dec 20, 2004		DISCN	No	No			Y	Y
Aspen	ENJUVIA	estrogens, conjugated synthetic b	TABLET;ORAL	021443-002	Dec 20, 2004		DISCN	No	No			Y	Y
Aspen	ENJUVIA	estrogens, conjugated synthetic b	TABLET;ORAL	021443-004	May 10, 2004		DISCN	No	No			Y	Y
Aspen	ENJUVIA	estrogens, conjugated synthetic b	TABLET;ORAL	021443-001	Dec 20, 2004		DISCN	No	No			Y	Y
Aspen	ENJUVIA	estrogens, conjugated synthetic b	TABLET;ORAL	021443-002	Dec 20, 2004		DISCN	No	No			Y	Y
Aspen	ENJUVIA	estrogens, conjugated synthetic b	TABLET;ORAL	021443-005	Apr 27, 2007		DISCN	No	No			Y	Y
Aspen	ENJUVIA	estrogens, conjugated synthetic b	TABLET;ORAL	021443-005	Apr 27, 2007		DISCN	No	No			Y	Y

Premature patent expiration for: ENJUVIA

Expiration due to failure to pay maintenance fee

Patent Number	Tradename	Expiration Date
	ENJUVIA

International Patents for ENJUVIA

Country	Patent Number	Estimated Expiration
Japan	2011256181
Austria	377605
Japan	2004500396
European Patent Office	1267852
World Intellectual Property Organization (WIPO)	0168669
European Patent Office	1263770
Australia	4541701