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Last Updated: January 21, 2020

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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.

Drug Prices for drospirenone

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Drug Sales Revenue Trends for drospirenone

See drug sales revenues for drospirenone

Recent Clinical Trials for drospirenone

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

SponsorPhase
University of California, San FranciscoPhase 4
Quotient SciencesPhase 1
Janssen Sciences Ireland UCPhase 1

See all drospirenone clinical trials

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

Supplementary Protection Certificates for drospirenone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0398460 SPC/GB04/032 United Kingdom   Start Trial 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   Start Trial PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
0398460 04C0022 France   Start Trial 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   Start Trial PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
AstraZeneca
McKinsey
Medtronic
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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 verifification 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.