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ANGELIQ Drug Profile

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When do Angeliq patents expire, and when can generic versions of Angeliq launch?

Angeliq is a drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has twenty patent family members in seventeen countries.

The generic ingredient in ANGELIQ is drospirenone; estradiol. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the drospirenone; estradiol profile page.

Summary for ANGELIQ

International Patents:	20
US Patents:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Clinical Trials:	7
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ANGELIQ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ANGELIQ
DailyMed Link:	ANGELIQ at DailyMed

Generic Entry Opportunity Date for ANGELIQ

NDA:

021355

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.

Pharmacology for ANGELIQ

Ingredient-type	Estradiol Congeners Progesterone Congeners
Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for ANGELIQ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-001	Feb 29, 2012		RX	Yes	No			Y
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-002	Sep 28, 2005		RX	Yes	Yes

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Expired US Patents for ANGELIQ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-002	Sep 28, 2005

Paragraph IV (Patent) Challenges for ANGELIQ

Drugname	Dosage	Strength	RLD	Date
	Tablets	0.25 mg/0.5 mg
	Tablets	0.5 mg/1 mg

Non-Orange Book US Patents for ANGELIQ

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,592,245	Very low-dosed solid oral dosage forms for HRT

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International Patents for ANGELIQ

Country	Document Number	Estimated Expiration
European Patent Office	2558063
Israel	222353
World Intellectual Property Organization (WIPO)	2011128336
Costa Rica	20120523
Australia	2011240102

Supplementary Protection Certificates for ANGELIQ

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0022	France		PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
C/GB04/032	United Kingdom		PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310