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Last Updated: June 29, 2022

ANGELIQ Drug Patent 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.

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

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Summary for ANGELIQ
International Patents:22
US Patents:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 7
Formulation / Manufacturing:see details
Drug Prices: Drug price information for ANGELIQ
What excipients (inactive ingredients) are in ANGELIQ?ANGELIQ excipients list
DailyMed Link:ANGELIQ at DailyMed
Drug patent expirations by year for ANGELIQ
Drug Prices for ANGELIQ

See drug prices for ANGELIQ

DrugPatentWatch® Estimated 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
Bayer
BayerPhase 2

See all ANGELIQ clinical trials

Pharmacology for ANGELIQ
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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bayer Hlthcare ANGELIQ drospirenone; estradiol TABLET;ORAL 021355-002 Sep 28, 2005 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 11240102
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2012026115
Estimated Expiration: See Plans and Pricing

Canada

Patent: 95801
Estimated Expiration: See Plans and Pricing

China

Patent: 2985070
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 30107
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 120523
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 6095
Estimated Expiration: See Plans and Pricing

Patent: 1201403
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 58063
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 1200281
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2353
Estimated Expiration: See Plans and Pricing

Japan

Patent: 20465
Estimated Expiration: See Plans and Pricing

Patent: 13523860
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 6702
Estimated Expiration: See Plans and Pricing

Patent: 12012026
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 130097073
Estimated Expiration: See Plans and Pricing

Patent: 180018827
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 19300
Estimated Expiration: See Plans and Pricing

Patent: 1204368
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 343
Estimated Expiration: See Plans and Pricing

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
Hungary 9903089 See Plans and Pricing
South Korea 20180018827 초저-용량의 HRT용 고체 경구 투여 형태 (- VERY LOW-DOSED SOLID ORAL DOSAGE FORMS FOR HRT) See Plans and Pricing
Brazil 9711060 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ANGELIQ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0398460 04C0022 France See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing 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.