Details for New Drug Application (NDA): 021355

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NDA 021355 describes ANGELIQ, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the ANGELIQ profile page.

The generic ingredient in ANGELIQ is drospirenone; estradiol. There are eleven 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 021355

Tradename:	ANGELIQ
Applicant:	Bayer Hlthcare
Ingredient:	drospirenone; estradiol
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 021355

Generic Entry Date for 021355^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 NDA: 021355

Mechanism of Action	Estrogen Receptor Agonists

Suppliers and Packaging for NDA: 021355

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-482	50419-482-03	3 BLISTER PACK in 1 CARTON (50419-482-03) / 28 TABLET, FILM COATED in 1 BLISTER PACK (50419-482-01)
ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-482	50419-482-72	1 BLISTER PACK in 1 CARTON (50419-482-72) / 14 TABLET, FILM COATED in 1 BLISTER PACK (50419-482-71)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.25MG;0.5MG
Approval Date:	Feb 29, 2012	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Oct 22, 2031	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG;1MG
Approval Date:	Sep 28, 2005	TE:		RLD:	Yes

Expired US Patents for NDA 021355

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

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