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 Pharm, IPR, Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms Co, Apotex Inc, Aurobindo Pharma Ltd, Biocon Pharma, Cadila Pharms Ltd, Changzhou Pharm, Chartwell Rx, Glenmark Pharms, Hetero Labs Ltd V, Inventia, Lupin, MSN, Renata, Sandoz Inc, Sciegen Pharms Inc, Shandong, Strides Pharma, Sunshine, Teva Pharms Usa, Torrent, Umedica Labs Pvt Ltd, Watson Labs Inc, Zhejiang Jingxin, and Zhejiang Yongtai, and is included in twenty-nine 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 forty-five patent family members in thirty-four countries.

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

Summary for rosuvastatin calcium

International Patents:	45
US Patents:	2
Tradenames:	3
Applicants:	28
NDAs:	29
Drug Master File Entries:	40
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	30
Patent Applications:	7,216
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for rosuvastatin calcium
Drug Sales Revenues:	Drug sales revenues for rosuvastatin calcium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rosuvastatin calcium
What excipients (inactive ingredients) are in rosuvastatin calcium?	rosuvastatin calcium excipients list
DailyMed Link:	rosuvastatin calcium at DailyMed

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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

Sponsor	Phase
EMS	Phase 3
Chinese University of Hong Kong	N/A
Ottawa Hospital Research Institute	Phase 3

See all rosuvastatin calcium clinical trials

Pharmacology for rosuvastatin calcium

Drug Class	HMG-CoA Reductase Inhibitor
Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for rosuvastatin calcium

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Paragraph IV (Patent) Challenges for ROSUVASTATIN CALCIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CRESTOR	Tablets	rosuvastatin calcium	5 mg, 10 mg, 20 mg and 40 mg	021366	9	2007-08-13

US Patents and Regulatory Information for rosuvastatin calcium

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms Co	ROSUVASTATIN CALCIUM	rosuvastatin calcium	TABLET;ORAL	208850-003	Oct 16, 2018		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Changzhou Pharm	ROSUVASTATIN CALCIUM	rosuvastatin calcium	TABLET;ORAL	207408-003	Oct 31, 2016	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Apotex Inc	ROSUVASTATIN CALCIUM	rosuvastatin calcium	TABLET;ORAL	079145-002	Jul 19, 2016		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Ipr	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366-002	Aug 12, 2003	AB	RX	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Watson Labs Inc	ROSUVASTATIN CALCIUM	rosuvastatin calcium	TABLET;ORAL	079167-003	Apr 29, 2016	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Chartwell Rx	ROSUVASTATIN CALCIUM	rosuvastatin calcium	TABLET;ORAL	079168-002	Jul 19, 2016	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Watson Labs Inc	ROSUVASTATIN CALCIUM	rosuvastatin calcium	TABLET;ORAL	079167-001	Apr 29, 2016	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and 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

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

International Patents for rosuvastatin calcium

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1339409	UTILISATION DE LA ROSUVASTATINE (ZD-4522) DANS LE TRAITEMENT DE L'HYPERCHOLESTEROLEMIE FAMILIALE (USE OF ROSUVASTATIN (ZD-4522) IN THE TREATMENT OF HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA)	See Plans and Pricing
New Zealand	525754	Use of rosuvastatin (ZD-4522) in the treatment of heterozygous familial hypercholesterolemia	See Plans and Pricing
United Kingdom	0028429		See Plans and Pricing
Austria	394103		See Plans and Pricing
Russian Federation	2294744	ПРИМЕНЕНИЕ РОЗУВАСТАТИНА (ZD-4522) В ЛЕЧЕНИИ ГЕТЕРОЗИГОТНОЙ СЕМЕЙНОЙ ГИПЕРХОЛЕСТЕРИНЕМИИ (APPLICATION OF ROSUVASTATIN (ZD-4522) IN TREATING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA)	See Plans and Pricing
Estonia	200300239		See Plans and Pricing
Australia	2002214165		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for rosuvastatin calcium

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0521471	C300125	Netherlands	See Plans and 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
0521471	0391023-9	Sweden	See Plans and Pricing	PRODUCT NAME: ROSUVASTATIN
0521471	03C0043	France	See Plans and Pricing	PRODUCT NAME: ROSUVASTATIN; NAT. REGISTRATION NO/DATE: NL 28 274 20030611; FIRST REGISTRATION: NL - 26872 20021106
0720599	300688	Netherlands	See Plans and 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
0720599	92544	Luxembourg	See Plans and 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
0720599	CR 2014 00048	Denmark	See Plans and 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	SPC/GB03/033	United Kingdom	See Plans and 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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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