You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: June 20, 2024

~ Buy the ANGELIQ (drospirenone; estradiol) Drug Profile, 2024 PDF Report in the Report Store ~

ANGELIQ Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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-one patent family members in sixteen 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.

DrugPatentWatch® 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 are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

< Available with Subscription >

  Sign Up

Summary for ANGELIQ
Drug patent expirations by year for ANGELIQ
Drug Prices for ANGELIQ

See drug prices for ANGELIQ

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Bayer
BayerPhase 2

See all ANGELIQ clinical trials

Pharmacology for ANGELIQ
Drug ClassEstrogen
Progestin
Mechanism of ActionEstrogen Receptor Agonists
Paragraph IV (Patent) Challenges for ANGELIQ
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ANGELIQ Tablets drospirenone; estradiol 0.25 mg/0.5 mg 021355 1 2015-01-08
ANGELIQ Tablets drospirenone; estradiol 0.5 mg/1 mg 021355 1 2007-12-26

US Patents and Regulatory Information for ANGELIQ

ANGELIQ is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ANGELIQ is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ANGELIQ

Very low-dosed solid oral dosage forms for HRT
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

International Patents for ANGELIQ

When does loss-of-exclusivity occur for ANGELIQ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 0912
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 11240102
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2012026115
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 95801
Estimated Expiration: ⤷  Sign Up

China

Patent: 2985070
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 30107
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 120523
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 6095
Estimated Expiration: ⤷  Sign Up

Patent: 1201403
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 58063
Estimated Expiration: ⤷  Sign Up

Guatemala

Patent: 1200281
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 20465
Estimated Expiration: ⤷  Sign Up

Patent: 13523860
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 6702
Estimated Expiration: ⤷  Sign Up

Patent: 12012026
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 130097073
Estimated Expiration: ⤷  Sign Up

Patent: 180018827
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 19300
Estimated Expiration: ⤷  Sign Up

Patent: 1204368
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 343
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ANGELIQ around the world.

Country Patent Number Title Estimated Expiration
Canada 2795801 FORMES PHARMACEUTIQUES ORALES SOLIDES A TRES FAIBLE DOSE POUR HRT (VERY LOW-DOSED SOLID ORAL DOSAGE FORMS FOR HRT) ⤷  Sign Up
Germany 19633685 Verfahren zur Herstellung von Drospirenon (6beta,7beta;15 beta,16beta-Dimethyl-en-3-oxo-17alpha-pregn-4-en-21,17-carbolacton, DRSP) sowie 7alpha-(3-Hydroxy-1-propyl)-6beta,7beta;15beta, 16beta-dimethylen-5beta-androstan-3beta,5,17beta-triol (ZK 92836) und 6beta,7beta;15beta,16beta-dimethylen-5beta-hydroxy-3-oxo-17alpha-androstan-21,17-carbolacton (90965) als Zwischenprodukte des Verfahrens (Production of drospirenone useful as steroidal agent) ⤷  Sign Up
Spain 2320626 ⤷  Sign Up
Iceland 2100 ⤷  Sign Up
New Zealand 333697 Production of Drospirenone (6beta,7beta,15beta,16beta-dimethylene-3-oxo-17alpha-preg-4-en-21,17-carbolactone, DRSP), and an androstane-triol (ZK 92836) and an androstane-carbolactone (90965) as intermediates ⤷  Sign Up
South Korea 20130097073 VERY LOW-DOSED SOLID ORAL DOSAGE FORMS FOR HRT ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ANGELIQ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3632448 22C1031 France ⤷  Sign Up PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 31332 20191016
3632448 LUC00266 Luxembourg ⤷  Sign Up PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
0398460 04C0022 France ⤷  Sign Up 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 ⤷  Sign Up 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
2588114 LUC00227 Luxembourg ⤷  Sign Up PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022
0398460 SPC/GB04/032 United Kingdom ⤷  Sign Up 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

Make Better Decisions: Try a trial or see plans & pricing

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.