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Generated: December 17, 2018

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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 rosuvastatin calcium patent protection?

Rosuvastatin calcium is the generic ingredient in two branded drugs marketed by 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 Pharms Inc, Sandoz Inc, Sun Pharma Global, Teva Pharms Usa, Torrent Pharms Ltd, and Watson Labs Inc, and is included in twenty-one NDAs. There are four 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 thirty-one patent family members in forty-nine countries.

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

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,5R)-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)-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)
(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
Astende
AZD-4522
BDBM18372
Bio-0143
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
BSPBio_003429
C22H28FN3O6S
C44H54CaF2N6O12S2
CA009169
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
Cirantan
Cresadex
Creston
Creston (TN)
Crestor
Crestor (TN)
CS-2112
D01915
D08492
D0JE2E
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
Pyrimidine Compound, 26
Q-201685
R0180
Razel
Rosedex
Rosimol
Rostar
Rosumed
Rosustatin
Rosuvas
Rosuvast
Rosuvastatin
Rosuvastatin (INN)
Rosuvastatin [INN:BAN]
Rosuvastatin [INN]
Rosuvastatin calcium (JAN/USAN)
Rosuvastatin calcium [USAN]
Rosuvastatin Calcium Salt
Rosuvastatin hemicalcium
Rosuvastatin zinc
Rosuvastatin-3H
Rosuvastatincalcium
Rosvel
Rovartal
Rovista
RT-017537
S 4522
S-4522
SBI-0206727.P001
SCHEMBL150740
SCHEMBL154400
SCHEMBL2520
SCHEMBL429217
Shufutan
Simestat
Sinlip
SPECTRUM1505213
Spectrum5_001695
ST2413786
TL8006179
UNII-413KH5ZJ73
UNII-83MVU38M7Q
Vivacor
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
Biocon Ltd ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 207752-003 Oct 31, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Cadila Pharms Ltd ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 207453-003 Nov 23, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sandoz Inc ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079171-004 Jul 19, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Torrent Pharms Ltd ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 201619-003 Oct 31, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aurobindo Pharma Ltd ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079170-004 Jul 19, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sun Pharma Global ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079169-002 Jul 19, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for rosuvastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-004 Aug 12, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-005 Aug 12, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-004 Aug 12, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-002 Aug 12, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-003 Aug 12, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Ipr CRESTOR rosuvastatin calcium TABLET;ORAL 021366-004 Aug 12, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for rosuvastatin calcium

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0688 Netherlands ➤ Try a Free Trial 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
C0043 France ➤ Try a Free Trial PRODUCT NAME: ROSUVASTATIN; NAT. REGISTRATION NO/DATE: NL 28 274 20030611; FIRST REGISTRATION: NL - 26872 20021106
91023-9 Sweden ➤ Try a Free Trial PRODUCT NAME: ROSUVASTATIN
00125 Netherlands ➤ Try a Free Trial 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
2014 00048 Denmark ➤ Try a Free 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
C/GB03/033 United Kingdom ➤ Try a Free Trial 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Baxter
Colorcon
Boehringer Ingelheim
US Department of Justice
Medtronic
Cerilliant
Fuji
Healthtrust

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.