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Last Updated: October 14, 2019

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Rosuvastatin calcium - Generic Drug Details

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What are the generic sources for rosuvastatin calcium and what is the scope of freedom to operate?

Rosuvastatin calcium is the generic ingredient in three branded drugs marketed by Sun Pharma Global, IPR, Accord Hlthcare, Alkem Labs Ltd, Allied, Amneal Pharms Co, Apotex Inc, Aurobindo Pharma Ltd, Biocon Ltd, Cadila Pharms Ltd, Changzhou Pharm, Glenmark Pharms, Hetero Labs Ltd V, Jubilant Generics, Lupin Ltd, Msn Labs Pvt Ltd, Mylan, Sandoz Inc, Sciegen Pharms Inc, Shandong, Sun Pharm, Teva Pharms Usa, Torrent, Umedica Labs Pvt Ltd, Watson Labs Inc, and Zydus Pharms, and is included in twenty-six NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Rosuvastatin calcium has two hundred patent family members in forty-nine countries.

There are forty-two drug master file entries for rosuvastatin calcium. Forty-six suppliers are listed for this compound.

Drug Prices for rosuvastatin calcium

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Drug Sales Revenue Trends for rosuvastatin calcium

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Recent Clinical Trials for rosuvastatin calcium

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

SponsorPhase
Damanhour UniversityPhase 4
Tanta UniversityPhase 4
University of CoimbraPhase 4

See all rosuvastatin calcium clinical trials

Recent Litigation for rosuvastatin calcium

Identify potential future generic entrants

District Court Litigation
Case NameDate
Amgen Inc. v. Accord Healthcare, Inc.2018-06-28
Amgen Inc. v. Amneal Pharmaceuticals2016-09-22
MUSC Foundation for Research Development v. AstraZeneca Pharmaceuticals LP2013-12-09

See all rosuvastatin calcium litigation

Pharmacology for rosuvastatin calcium
Medical Subject Heading (MeSH) Categories for rosuvastatin calcium
Synonyms for rosuvastatin calcium
(3R,5R)-Rosuvastatin
(3R,5S,6E)-7-(4-(4-fluorophenyl)-6-(1-methylethyl)-2-(ethyl(methylsulfonyl)amino)-5-pyrimidinyl)-3,5-dihydroxy-6-heptenoic acid
(3R,5S,6E)-7-[4-(4-fluorophenyl)-2-(N-methylmethanesulfonamido)-6-(propan-2-yl)pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic acid
(3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic Acid Calcium Salt
(3R,5S,6E)-7-{4-(4-fluorophenyl)-2-[methyl(methylsulfonyl)amino]-6-(propan-2-yl)pyrimidin-5-yl}-3,5-dihydroxyhept-6-enoic acid
(3R,5S,6E)-7-{4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl}-3,5-dihydroxyhept-6-enoic acid
(3R,5S,E)-7-(4-(4-Fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6-enoic acid
(3R,5S)-7-[4-(4-fluorophenyl)-2-(methyl-methylsulfonylamino)-6-propan-2-ylpyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic acid
(3R,5S)-trans-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6-enoic acid
(E,3R,5S)-7-[4-(4-fluorophenyl)-2-[methyl(methylsulfonyl)amino]-6-propan-2-ylpyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic acid
(E,3R,5S)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-3,5-dihydroxy-hept-6-enoic acid
(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid
(E)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid
(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6enoic acid
(S-((R*,S*-(E)))- 7-(4-(4-fluorophenyl)-6-(1-methylethyl)-2-(methyl(methylsulfonyl) amino)-5-pyrimidinyl)-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1)
(S-((R*,S*-(E)))- 7-(4-(4-fluorophenyl)-6-(1-methylethyl)-2-(methyl(methylsulfonyl) amino)-5-pyrimidinyl)-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1)
(S-(R*,S*-(E)))-7-(4-(4-Fluorophenyl)-6-(1-methylethyl)-2-(methyl(methylsulfonyl)amino)-5-pyrimidinyl)-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1)
1094100-06-7
1354641-86-3
147098-20-2
147098-20-2 (Calcium)
2695AH
28050-EP2269990A1
28050-EP2272841A1
28050-EP2272842A1
28050-EP2280006A1
28050-EP2281813A1
28050-EP2284158A1
28050-EP2287165A2
28050-EP2287166A2
28050-EP2292620A2
28050-EP2295406A1
28050-EP2298731A1
28050-EP2298742A1
28050-EP2298745A1
28050-EP2298772A1
28050-EP2298776A1
28050-EP2298779A1
28050-EP2301923A1
28050-EP2301931A1
28050-EP2301936A1
28050-EP2308839A1
28050-EP2314588A1
287714-41-4
2C22H27FN3O6S.Ca
3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic Acid-3H
413KH5ZJ73
6-Heptenoic acid, 7-(4-(4-fluorophenyl)-6-(1-methylethyl)-2-(ethyl(methylsulfonyl)amino)-5-pyrimidinyl)-3,5-dihydroxy-, (3R,5S,6E)
6-Heptenoic acid, 7-(4-(4-fluorophenyl)-6-(1-methylethyl)-2-(methyl(methylsulfonyl)amino)-5-pyrimidinyl)-3,5-dihydroxy-, calcium salt (2:1), (3R,5S,6E)
6-Heptenoic acid, 7-(4-(4-fluorophenyl)-6-(1-methylethyl)-2-(methyl(methylsulfonyl)amino)-5-pyrimidinyl)-3,5-dihydroxy-, calcium salt (2:1), (3R,5S,6E)-
7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-(methyl-methylsulfonyl-amino)-pyrimidin-5-yl]-3,5-dihydroxy-hept-6-enoic acid;Rosuvastatin;Rosuvastatin Acid
83MVU38M7Q
A24862
AC1L9J7O
AC1NR03S
AJ-26825
AK144736
AKOS000280777
AKOS005145896
AKOS017343682
AM84890
AN-29122
AN-5353
AS-12247
AS-12488
AZD-4522
BCP04131
BDBM18372
bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhelpt-6-enoic acid] calcium salt
BPRHUIZQVSMCRT-VEUZHWNKSA-N
BRD-K82941592-001-01-3
BRD-K82941592-238-02-9
BSPBio_003429
C22H28FN3O6S
calcium (3R,5S,E)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6-enoate
calcium (E,3R,5S)-7-[4-(4-fluorophenyl)-2-[methyl(methylsulfonyl)amino]-6-propan-2-ylpyrimidin-5-yl]-3,5-dihydroxyhept-6-enoate
calcium (E,3R,5S)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-3,5-dihydroxy-hept-6-enoate
calcium bis[(3R,5S,6E)-7-{4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl}-3,5-dihydroxyhept-6-enoate]
calcium;(E,3R,5S)-7-[4-(4-fluorophenyl)-2-[methyl(methylsulfonyl)amino]-6-propan-2-ylpyrimidin-5-yl]-3,5-dihydroxyhept-6-enoate
CCG-40119
CHEBI:38545
CHEBI:77249
CHEBI:93454
CHEMBL1496
CHEMBL1744447
Creston (TN)
Crestor
Crestor (TN)
CS-2112
D01915
D08492
DB01098
DTXSID8048492
E-(7-{2-(N-methyl-N-methanesulfonylamino)-4-(4-fluorophenyl)-6-isopropyl-pyrimidin-5-yl}-(3R,5S)-3,5-dihydroxy-hept-6-enoic acid]
E-7-[2-(N-methyl-N-methanesulfonylamino)-4-(4-fluorophenyl)-6-isopropyl-pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid
Fortius
GTPL2954
HMS1922N09
HSDB 7317
HY-17504A
I06-044
KB-125361
KS-1109
LALFOYNTGMUKGG-BGRFNVSISA-L
LS-181805
LS-187345
MolPort-000-883-884
MolPort-003-987-534
MolPort-044-724-033
NCGC00178070-01
Provisacor
Q-201685
R0180
Rostar
Rosuvastatin
Rosuvastatin (INN)
Rosuvastatin [INN:BAN]
Rosuvastatin calcium (JAN/USAN)
Rosuvastatin calcium [USAN]
Rosuvastatin Calcium Salt
Rosuvastatin hemicalcium
Rosuvastatin-3H
Rovista
RT-017537
S 4522
S-4522
SBI-0206727.P001
SCHEMBL150740
SCHEMBL154400
SCHEMBL2520
SCHEMBL429217
Shufutan
SPECTRUM1505213
Spectrum5_001695
ST2413786
TL8006179
UNII-413KH5ZJ73
UNII-83MVU38M7Q
ZD 4522
ZD 4522 Calcium Salt
ZD 4522, calcium salt
ZD-4522
ZD-4522 (Calcium salt)
ZD4522
ZD4522 (calcium salt)
ZINC1535101

US Patents and Regulatory Information for rosuvastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-003 Aug 12, 2003 AB RX Yes No   See Pricing   See Pricing Y   See Pricing
Sun Pharm ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079169-004 Jul 19, 2016 AB RX No No   See Pricing   See Pricing   See Pricing
Aurobindo Pharma Ltd ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079170-003 Jul 19, 2016 AB RX No No   See Pricing   See Pricing   See Pricing
Amneal Pharms Co ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 208850-003 Oct 16, 2018 DISCN No No   See Pricing   See Pricing   See Pricing
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003 AB RX Yes Yes   See Pricing   See Pricing   See Pricing
Apotex Inc ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079145-001 Jul 19, 2016 AB RX No No   See Pricing   See Pricing   See Pricing
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-004 Aug 12, 2003 AB RX Yes No   See Pricing   See Pricing   See Pricing
>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 rosuvastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003   See Pricing   See Pricing
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-004 Aug 12, 2003   See Pricing   See Pricing
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-002 Aug 12, 2003   See Pricing   See Pricing
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-004 Aug 12, 2003   See Pricing   See Pricing
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-002 Aug 12, 2003   See Pricing   See Pricing
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003   See Pricing   See Pricing
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-003 Aug 12, 2003   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for rosuvastatin calcium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0720599 300688 Netherlands   See Pricing PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NATIONAL REGISTRATION NO/DATE: RVG114002-004 20140811; FIRST REGISTRATION: NO 13-9663 - 9665 20140724
0521471 0391023-9 Sweden   See Pricing PRODUCT NAME: ROSUVASTATIN
0720599 CR 2014 00048 Denmark   See Pricing PRODUCT NAME: KOMBINATION AF ROSUVASTATIN OG EZETIMIBE ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER ROSUVASTATIN SOM ZINK; NAT. REG. NO/DATE: 52921, 52922, 52923 20140820; FIRST REG. NO/DATE: NO 13-9663, 13-9664, 13-9665 20140724
0521471 03C0043 France   See Pricing PRODUCT NAME: ROSUVASTATIN; NAT. REGISTRATION NO/DATE: NL 28 274 20030611; FIRST REGISTRATION: NL - 26872 20021106
0720599 92544 Luxembourg   See Pricing PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ROSUVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ROSUVASTATINE SOUD FORME DE SEL DE ZINC; FIRST REGISTRATION DATE: 20140724
0521471 SPC/GB03/033 United Kingdom   See Pricing PRODUCT NAME: ROSUVASTATIN OPTIONALLY IN THE FORM OF A NON-TOXIC PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE CALCIUM SALT.; REGISTERED: NL 26872 20021106; NL 26873 20021106; NL 26874 20021106; UK PL 17901/0201 20030321; UK PL 17901/0202 20030321; UK PL 17901/0203 20030321
0521471 C300125 Netherlands   See Pricing PRODUCT NAME: ROSUVASTATINUM, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET CALCIUMZOUT; REGISTRATION NO/DATE: RVG 26872 - RVG 26874 20021106
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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