DROSPIRENONE; ESTRADIOL - Generic Drug Details

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What are the generic sources for drospirenone; estradiol and what is the scope of freedom to operate?

Drospirenone; estradiol is the generic ingredient in one branded drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Drospirenone; estradiol has twenty-one patent family members in sixteen countries.

One supplier is listed for this compound.

Summary for DROSPIRENONE; ESTRADIOL

International Patents:	21
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	49
DailyMed Link:	DROSPIRENONE; ESTRADIOL at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DROSPIRENONE; ESTRADIOL

Generic Entry Date for DROSPIRENONE; ESTRADIOL^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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; ESTRADIOL

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

Sponsor	Phase
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4
Eli Lilly and Company	Phase 1
Bristol-Myers Squibb	Phase 1

See all DROSPIRENONE; ESTRADIOL clinical trials

Pharmacology for DROSPIRENONE; ESTRADIOL

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for DROSPIRENONE; ESTRADIOL

G03AC	Progestogens
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for DROSPIRENONE; ESTRADIOL

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 DROSPIRENONE; ESTRADIOL

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Glossary

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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

Expired US Patents for DROSPIRENONE; ESTRADIOL

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-002	Sep 28, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for DROSPIRENONE; ESTRADIOL

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2558063	FORMULATION SOLIDE A TRÈS BAS DOSAGE POUR LA THERAPIE HORMONALE DE REMPLACEMENT (MENOPAUSE) (VERY LOW-DOSED SOLID ORAL DOSAGE FORMS FOR HRT)	⤷ Sign Up
Taiwan	I519300		⤷ Sign Up
Eurasian Patent Organization	201201403	ОЧЕНЬ НИЗКОДОЗИРОВАННЫЕ ТВЕРДЫЕ ПЕРОРАЛЬНЫЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ ДЛЯ ГЗТ	⤷ Sign Up
Guatemala	201200281	FORMAS DE DOSIFICACIÓN SÓLIDAS ORALES CON DOSIS MUY BAJAS PARA LA HRT	⤷ Sign Up
Japan	2013523860		⤷ Sign Up
Argentina	080912	FORMAS DE DOSIFICACION SOLIDAS ORALES CON DOSIS MUY BAJAS PARA LA HRT	⤷ Sign Up
Eurasian Patent Organization	026095	ОЧЕНЬ НИЗКОДОЗИРОВАННЫЕ ТВЕРДЫЕ ПЕРОРАЛЬНЫЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ ДЛЯ ГОРМОНОЗАМЕСТИТЕЛЬНОЙ ТЕРАПИИ (ГЗТ) (VERY LOW-DOSED SOLID ORAL DOSAGE FORMS FOR HORMONE REPLACEMENT THERAPY (HRT))	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for DROSPIRENONE; ESTRADIOL

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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
3632448	22C1031	France	⤷ Sign Up	PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 61678 20191016
2588114	LUC00227	Luxembourg	⤷ Sign Up	PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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