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Last Updated: January 24, 2020

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Rosuvastatin calcium - Generic Drug Details

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What are the generic drug sources for rosuvastatin calcium and what is the scope of patent protection?

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, Zhejiang Yongtai, and Zydus Pharms, and is included in twenty-seven NDAs. There are three 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 and two patent family members in forty-nine countries.

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

Drug Prices for rosuvastatin calcium

See drug prices for rosuvastatin calcium

Drug Sales Revenue Trends for rosuvastatin calcium

See drug sales revenues for rosuvastatin calcium

Recent Clinical Trials for rosuvastatin calcium

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

SponsorPhase
Chinese University of Hong KongN/A
Damanhour UniversityPhase 4
Tanta UniversityPhase 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
Paragraph IV (Patent) Challenges for ROSUVASTATIN CALCIUM
Tradename Dosage Ingredient NDA Submissiondate
CRESTOR TABLET;ORAL rosuvastatin calcium 021366 2007-08-13

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
Alkem Labs Ltd ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 206465-004 Mar 21, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz Inc ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079171-003 Jul 19, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 206513-002 Mar 1, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079166-004 Jul 19, 2016 DISCN 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

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   Start Trial   Start Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-003 Aug 12, 2003   Start Trial   Start Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-002 Aug 12, 2003   Start Trial   Start Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003   Start Trial   Start Trial
>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 92544 Luxembourg   Start Trial 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
0720599 CR 2014 00048 Denmark   Start Trial 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   Start Trial PRODUCT NAME: ROSUVASTATIN; NAT. REGISTRATION NO/DATE: NL 28 274 20030611; FIRST REGISTRATION: NL - 26872 20021106
0521471 0390023-0 Sweden   Start Trial PRODUCT NAME: ROSUVASTATIN
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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