You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: October 31, 2024

DROSPIRENONE; ESTETROL - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for drospirenone; estetrol and what is the scope of patent protection?

Drospirenone; estetrol is the generic ingredient in one branded drug marketed by Mayne Pharma and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Drospirenone; estetrol has two hundred and two patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for DROSPIRENONE; ESTETROL
International Patents:202
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 10
DailyMed Link:DROSPIRENONE; ESTETROL at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DROSPIRENONE; ESTETROL
Generic Entry Date for DROSPIRENONE; ESTETROL*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
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 DROSPIRENONE; ESTETROL

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

SponsorPhase
McGill University Health Centre/Research Institute of the McGill University Health CentrePhase 4
Quotient SciencesPhase 1
EstetraPhase 2

See all DROSPIRENONE; ESTETROL clinical trials

US Patents and Regulatory Information for DROSPIRENONE; ESTETROL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mayne Pharma NEXTSTELLIS drospirenone; estetrol TABLET;ORAL 214154-001 Apr 15, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Mayne Pharma NEXTSTELLIS drospirenone; estetrol TABLET;ORAL 214154-001 Apr 15, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mayne Pharma NEXTSTELLIS drospirenone; estetrol TABLET;ORAL 214154-001 Apr 15, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Mayne Pharma NEXTSTELLIS drospirenone; estetrol TABLET;ORAL 214154-001 Apr 15, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for DROSPIRENONE; ESTETROL

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Estetra SPRL Lydisilka estetrol, drospirenone EMEA/H/C/005382
Oral contraception.The decision to prescribe Lydisilka should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Lydisilka compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
Authorised no no no 2021-05-19
Gedeon Richter Plc. Drovelis estetrol, drospirenone EMEA/H/C/005336
oral contraceptive
Authorised no no no 2021-05-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for DROSPIRENONE; ESTETROL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
3701944 PA2022508 Lithuania ⤷  Sign Up PRODUCT NAME: DROSPIRENONAS DERINYJE SU ESTETROLIU; REGISTRATION NO/DATE: EU/1/21/1547 20210519
3632448 LUC00266 Luxembourg ⤷  Sign Up PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
2588114 LUC00227 Luxembourg ⤷  Sign Up PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022
>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.