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Last Updated: October 21, 2019

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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-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.

Drug patent expirations by year for ANGELIQ
Drug Prices for ANGELIQ

See drug prices for ANGELIQ

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

Recent Litigation for ANGELIQ

Identify potential future generic entrants

District Court Litigation
Case NameDate
Bayer Schering Pharma AG v. Mylan Pharmaceuticals Inc.2011-04-19
Bayer Schering Pharma AG v. Sun Pharmaceutical Industries, Inc.2011-01-12
Bayer Schering Pharma AG v. Lupin Ltd.2010-07-15

See all ANGELIQ litigation

Pharmacology for ANGELIQ

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
Paragraph IV (Patent) Challenges for ANGELIQ
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 0.25 mg/0.5 mg ➤ Subscribe   Start Trial
➤ Subscribe Tablets 0.5 mg/1 mg ➤ Subscribe   Start Trial

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
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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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
Harvard Business School
McKesson

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