Pitavastatin calcium - Generic Drug Details
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What are the generic sources for pitavastatin calcium and what is the scope of patent protection?
Pitavastatin calcium
is the generic ingredient in two branded drugs marketed by Kowa Co, Aurobindo Pharma, Mylan, Orient Pharma Co Ltd, and Sawai Usa, and is included in five NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Pitavastatin calcium has fifty-three patent family members in seventeen countries.
There are thirteen drug master file entries for pitavastatin calcium. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for pitavastatin calcium
International Patents: | 53 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 5 |
NDAs: | 5 |
Drug Master File Entries: | 13 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 109 |
Clinical Trials: | 2 |
Patent Applications: | 7,001 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for pitavastatin calcium |
What excipients (inactive ingredients) are in pitavastatin calcium? | pitavastatin calcium excipients list |
DailyMed Link: | pitavastatin calcium at DailyMed |
Recent Clinical Trials for pitavastatin calcium
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Jun Tao | Phase 4 |
Sun Yat-sen University | Phase 4 |
Chonbuk National University Hospital | Phase 4 |
Generic filers with tentative approvals for PITAVASTATIN CALCIUM
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | EQ 4MG BASE | TABLET;ORAL |
See Plans and Pricing | See Plans and Pricing | EQ 2MG BASE | TABLET;ORAL |
See Plans and Pricing | See Plans and Pricing | EQ 1MG BASE | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for pitavastatin calcium
Drug Class | HMG-CoA Reductase Inhibitor |
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sawai Usa | PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 205955-001 | Feb 3, 2017 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-003 | Aug 3, 2009 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Mylan | PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 206070-001 | Apr 4, 2019 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-003 | Aug 3, 2009 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | 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 pitavastatin calcium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-002 | Aug 3, 2009 | See Plans and Pricing | See Plans and Pricing |
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-001 | Aug 3, 2009 | See Plans and Pricing | See Plans and Pricing |
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-003 | Aug 3, 2009 | See Plans and Pricing | See Plans and Pricing |
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-003 | Aug 3, 2009 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for pitavastatin calcium
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2014062115 | NOVEL CRYSTALLINE FORM OF PITAVASTATIN CALCIUM | See Plans and Pricing |
European Patent Office | 3299359 | FORMES CRISTALLINES ET AMORPHE DU SEL HEMICALCIUM DE PITAVASTATIN (CRYSTALLINE AND AMORPHOUS FORMS OF PITAVASTATIN HEMICALCIUM SALT) | See Plans and Pricing |
Australia | 2004212160 | Crystalline forms of pitavastatin calcium | See Plans and Pricing |
Hong Kong | 1098953 | HYPERLIPEMIA THERAPEUTIC AGENT | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
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