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Last Updated: November 15, 2019

DrugPatentWatch Database Preview

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
Generic Entry Opportunity Date for 021355
Generic Entry Date for 021355*:
Constraining patent/regulatory exclusivity:
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 ActionEstrogen 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)
Paragraph IV (Patent) Challenges for 021355
Tradename Dosage Ingredient NDA Submissiondate
ANGELIQ TABLET;ORAL drospirenone; estradiol 021355 2015-01-08
ANGELIQ TABLET;ORAL drospirenone; estradiol 021355 2007-12-26

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG;0.5MG
Approval Date:Feb 29, 2012TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Oct 22, 2031Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG;1MG
Approval Date:Sep 28, 2005TE:RLD:Yes

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