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-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
Summary for ANGELIQ
International Patents: | 21 |
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 |


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
Sponsor | Phase |
---|---|
Brigham and Women's Hospital | Phase 4 |
Bayer | |
Bayer | Phase 2 |
Pharmacology for ANGELIQ
Drug Class | Estrogen Progestin |
Mechanism of Action | Estrogen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes 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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Bayer Hlthcare | ANGELIQ | drospirenone; estradiol | TABLET;ORAL | 021355-002 | Sep 28, 2005 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ANGELIQ
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Hlthcare | ANGELIQ | drospirenone; estradiol | TABLET;ORAL | 021355-002 | Sep 28, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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: ⤷ Try a Trial
Australia
Patent: 11240102
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2012026115
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 95801
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2985070
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 30107
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 120523
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 6095
Estimated Expiration: ⤷ Try a Trial
Patent: 1201403
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 58063
Estimated Expiration: ⤷ Try a Trial
Guatemala
Patent: 1200281
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 20465
Estimated Expiration: ⤷ Try a Trial
Patent: 13523860
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 6702
Estimated Expiration: ⤷ Try a Trial
Patent: 12012026
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 130097073
Estimated Expiration: ⤷ Try a Trial
Patent: 180018827
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 19300
Estimated Expiration: ⤷ Try a Trial
Patent: 1204368
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 343
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
South Korea | 20180018827 | 초저-용량의 HRT용 고체 경구 투여 형태 (- VERY LOW-DOSED SOLID ORAL DOSAGE FORMS FOR HRT) | ⤷ Try a Trial |
China | 102985070 | Very low-dosed solid oral dosage forms for HRT | ⤷ Try a Trial |
Brazil | 112012026115 | formas de dosagem sólidas orais muito baixas para hrt | ⤷ Try a Trial |
Spain | 2175451 | ⤷ Try a Trial | |
Denmark | 0918791 | ⤷ Try a Trial | |
Poland | 331530 | ⤷ Try a Trial | |
Slovenia | 1149841 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ANGELIQ
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2588114 | LUC00227 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022 |
0398460 | SPC/GB04/032 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310 |
3632448 | LUC00266 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401 |
0918791 | PA2006009 | Lithuania | ⤷ Try a 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 | 04C0022 | France | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |