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Drospirenone - Generic Drug Details

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

Drospirenone is the generic ingredient in eighteen branded drugs marketed by Exeltis Usa Inc, Bayer Hlthcare, Anda Repository, Barr, Glenmark Pharms Ltd, Hetero Labs Ltd, Jubilant Cadista, Mylan Labs Ltd, Watson Labs, Sun Pharm, Aurobindo Pharma Ltd, Xiromed, Novast Labs, Lupin Ltd, Accord Hlthcare, Apotex, Mayne Pharma, and Watson Labs Inc, and is included in thirty-four NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Drospirenone has twenty-eight patent family members in seventeen countries.

There are eleven drug master file entries for drospirenone. One supplier is listed for this compound.

Summary for drospirenone

International Patents:	28
US Patents:	8
Tradenames:	18
Applicants:	18
NDAs:	34
Drug Master File Entries:	11
Suppliers / Packagers:	1
Bulk Api Vendors:	60
Clinical Trials:	88
Patent Applications:	1,675
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for drospirenone
Drug Sales Revenues:	Drug sales revenues for drospirenone
DailyMed Link:	drospirenone at DailyMed

See drug prices for drospirenone

See drug sales revenues for drospirenone

Recent Clinical Trials for drospirenone

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

Sponsor	Phase
University of California, San Francisco	Phase 4
Quotient Sciences	Phase 1
Janssen Sciences Ireland UC	Phase 1

See all drospirenone clinical trials

Pharmacology for drospirenone

Drug Class

Progestin

Synonyms for drospirenone

(1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0^{2,4}.0^{5,10}.0^{14,19}.0^{16,18}]nonadecane-15,2'-oxolan]-5-ene-5',7-dione

(1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-dimethylspiro[hexacyclo[9.8.0.0;{2,4}.0;{5,10}.0;{14,19}.0;{16,18}]nonadecane-15,2'-oxolan]-5-ene-5',7-dione

(4aR,4bS,6aS,7S,7aS,8aS,8bS,8cR,8dR,9aR)-4a,6a-dimethyl-3',4,4a,4b,4',5,6,6a,7a,8,8a,8b,8c,8d,9,9a-hexadecahydro-5'H-spiro[cyclopropa[4,5]cyclopenta[1,2-a]cyclopropa[l]phenanthrene-7,2'-f

(6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11,12,13,14,15,15a,16-Hexadecahydro-10,13-dimethylspiro-(17H-dicyclopropa(6,7:15,16)cyclopenta(a)phenanthrene-17,2'(5'H)-furan)-3,5'(2H)-dione

1, 2-Dihydrospirorenone

1,2-dihydro-spirorenone

1,2-Dihydrospirorenone

17-Hydroxy-6beta,7beta:15beta,16beta-dimethylene-3-oxo-17alpha-pregn-4-ene-21-carboxylic acid, gamma-lactone

3-oxo-6alpha,7alpha,15alpha,16alpha-tetrahydro-7'H,16'H-dicyclopropa[6,7;15,16]-17alpha-pregn-4-ene-21,17-carbolactone

392D874

6-beta,7-beta;15-beta,16-beta-Dimethylene-3-oxo-17-alpha-pregn-4-ene-21,17-carbolactone

6|A,7|A,15|A,16|A-dimethylene-3-oxo-17|A-pregn-4-ene-21,17 carbolactone

67392-87-4

6beta,7beta,15beta,16beta -Dimethylene-3-oxo-17alpha-pregn-4-ene-21,17-carbolactone

6beta,7beta,15beta,16beta-dimethylen-3-oxo-17alpha-pregn-4-en-21,17-carbolacton

6beta,7beta,15beta,16beta-dimethylene-3-oxo-17alpha-pregn-4-ene-21,17 carbolactone

6beta,7beta;15beta,16beta-Dimethylene-3-oxo-17alpha-pregn-4-ene-21,17-carbolactone

AB01274783_02

AB01274783-01

AB2000073

AC1L2AMM

AKOS015895237

AN-614

AS-13025

BCP27035

BCP9000628

BCPP000250

BDBM150275

BRD-K04394237-001-06-0

BRN 4765500

C-21042

C24H30O3

CAS-67392-87-4

CC-27405

CCRIS 6523

CHEBI:50838

CHEMBL1509

CS-1863

D03917

D4209

DB01395

Dehydrospirorenone

Dihydrospirorenone

Drospirenona

Drospirenona [INN-Spanish]

Drospirenone (JAN/USP/INN)

Drospirenone [INN]

Drospirenone [USAN:USP:INN:BAN]

Drospirenone for peak identification, European Pharmacopoeia (EP) Reference Standard

Drospirenone, >=98% (HPLC)

Drospirenone, European Pharmacopoeia (EP) Reference Standard

Drospirenone, United States Pharmacopeia (USP) Reference Standard

Drospirenonum

Drospirenonum [INN-Latin]

Drospireone

DRSP

DSSTox_CID_26465

DSSTox_GSID_46465

DSSTox_RID_81639

DTXSID7046465

EINECS 266-679-2

FT-0641122

GTPL2874

HSDB 7896

HY-B0111

LS-146115

METQSPRSQINEEU-HXCATZOESA-N

MFCD00867350

N295J34A25

NCGC00164590-01

NCGC00164590-02

PubChem24197

Q-101411

RP17696

s1377

SC-16105

SCHEMBL153316

SH-470

SR-01000942231

SR-01000942231-1

Tox21_112216

Tox21_112216_1

UNII-N295J34A25

uran]-2,5'(3H)-dione

US8987239, A

ZINC3927200

ZK 3059

ZK 30595

ZK-30595

ZK30595

US Patents and Regulatory Information for drospirenone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	AB	RX	Yes	Yes			Y
Mylan Labs Ltd	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL-28	202131-001	May 4, 2015	AB	RX	No	No
Watson Labs	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL	078833-001	Nov 28, 2011	AB	RX	No	No
Apotex	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL-28	205876-001	Sep 21, 2016	AB	RX	No	No
Hetero Labs Ltd	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL	211944-001	Mar 22, 2019	AB	RX	No	No
Sun Pharm	KEMEYA	drospirenone; ethinyl estradiol	TABLET;ORAL-28	202138-001	Mar 13, 2019	AB	RX	No	No

International Patents for drospirenone

Country	Patent Number	Estimated Expiration
Japan	2013529665
Peru	20130780
Eurasian Patent Organization	028680
South Korea	20170085604
Canada	3003062
Peru	20161410

Supplementary Protection Certificates for drospirenone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	SPC/GB04/032	United Kingdom		PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
0398460	04C0022	France		PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008