PITAVASTATIN CALCIUM Drug Patent Profile

When do Pitavastatin Calcium patents expire, and when can generic versions of Pitavastatin Calcium launch?

Pitavastatin Calcium is a drug marketed by Amneal Pharms Ny, Aurobindo Pharma, Hetero Labs Ltd V, Lupin Ltd, Mylan, Orient Pharma Co Ltd, Sawai Usa, and Zydus Pharms. and is included in eight NDAs.

The generic ingredient in PITAVASTATIN CALCIUM is pitavastatin calcium. There are fifteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the pitavastatin calcium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pitavastatin Calcium

A generic version of PITAVASTATIN CALCIUM was approved as pitavastatin calcium by AUROBINDO PHARMA on December 20^th, 2016.

Summary for PITAVASTATIN CALCIUM

US Patents:	0
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	2
Patent Applications:	3,854
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PITAVASTATIN CALCIUM
DailyMed Link:	PITAVASTATIN CALCIUM at DailyMed

Recent Clinical Trials for PITAVASTATIN CALCIUM

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

Sponsor	Phase
Sun Yat-sen University	Phase 4
Jun Tao	Phase 4
Gangnam Severance Hospital	Phase 4

See all PITAVASTATIN CALCIUM clinical trials

Pharmacology for PITAVASTATIN CALCIUM

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

Anatomical Therapeutic Chemical (ATC) Classes for PITAVASTATIN CALCIUM

C10AA	HMG CoA reductase inhibitors
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for PITAVASTATIN CALCIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LIVALO	Tablets	pitavastatin calcium	1 mg, 2 mg, and 4 mg	022363	7	2013-08-05

US Patents and Regulatory Information for PITAVASTATIN CALCIUM

PITAVASTATIN CALCIUM is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting PITAVASTATIN CALCIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms Ny	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	205961-001	Aug 20, 2024	AB	RX	No	No
Orient Pharma Co Ltd	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	205932-003	Feb 3, 2017	AB	RX	No	No
Zydus Pharms	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	206047-003	Feb 22, 2023	AB	RX	No	No
Hetero Labs Ltd V	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	205977-001	Apr 30, 2024	AB	RX	No	No
Aurobindo Pharma	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	206015-001	Dec 20, 2016	AB	RX	No	No
Lupin Ltd	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	206029-003	Nov 20, 2023	AB	RX	No	No
Sawai Usa	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	205955-002	Feb 3, 2017	AB	RX	No	No