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Last Updated: August 14, 2020

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ANGELIQ Drug Profile

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Which patents cover Angeliq, and what generic alternatives are available?

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-two patent family members in seventeen countries.

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.

US ANDA Litigation and Generic Entry Outlook for Angeliq

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 22, 2031. This may change due to patent challenges or generic licensing.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for ANGELIQ
Drug Prices for ANGELIQ

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Generic Entry Opportunity Date for ANGELIQ
Generic Entry Date for ANGELIQ*:
Constraining patent/regulatory exclusivity:
NDA:
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 ANGELIQ

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

SponsorPhase
Brigham and Women's HospitalPhase 4
BayerN/A
BayerPhase 2

See all ANGELIQ clinical trials

Pharmacology for ANGELIQ
Paragraph IV (Patent) Challenges for ANGELIQ
Tradename Dosage Ingredient NDA Submissiondate
ANGELIQ TABLET;ORAL drospirenone; estradiol 021355 2015-01-08
ANGELIQ TABLET;ORAL drospirenone; estradiol 021355 2007-12-26

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

Supplementary Protection Certificates for ANGELIQ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0398460 04C0022 France   Start Trial PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
0918791 PA2006009 Lithuania   Start Trial PRODUCT NAME: DROSPIRENONUM; NAT. REGISTRATION NO/DATE: LT/1/06/0520/001, 2006 07 10 LT/1/06/0520/002, 2006 07 10 LT/1/06/0520/003, 2006 07 10 LT/1/06/0520/004 20060710; FIRST REGISTRATION: RVG 31781 20050804
0398460 SPC/GB04/032 United Kingdom   Start Trial PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.