Pitavastatin calcium - Generic Drug Details
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What are the generic drug sources for pitavastatin calcium and what is the scope of freedom to operate?
Pitavastatin calcium
is the generic ingredient in two branded drugs marketed by Kowa Co, 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 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.Pitavastatin calcium has fifty-three patent family members in seventeen countries.
There are thirteen drug master file entries for pitavastatin calcium. Ten suppliers are listed for this compound.
Summary for pitavastatin calcium
International Patents: | 53 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 9 |
NDAs: | 9 |
Drug Master File Entries: | 13 |
Finished Product Suppliers / Packagers: | 10 |
Raw Ingredient (Bulk) Api Vendors: | 64 |
Clinical Trials: | 2 |
Patent Applications: | 7,186 |
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 |
---|---|
Sun Yat-sen University | Phase 4 |
Jun Tao | Phase 4 |
Chungnam National University Hospital | Phase 4 |
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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hetero Labs Ltd V | PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 205977-002 | Apr 30, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Lupin Ltd | PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 206029-001 | Nov 20, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Orient Pharma Co Ltd | PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 205932-002 | Feb 3, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Amneal Pharms Ny | PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 205961-003 | Aug 20, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sawai Usa | PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 205955-002 | Feb 3, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 | 022363-001 | Aug 3, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-003 | Aug 3, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-003 | Aug 3, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-002 | Aug 3, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-002 | Aug 3, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for pitavastatin calcium
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 5474276 | ⤷ Sign Up | |
South Korea | 20060109988 | HYPERLIPEMIA THERAPEUTIC AGENT COMPRISING PITAVASTATINS AND EICOSAPENTAENOIC ACID | ⤷ Sign Up |
European Patent Office | 1592668 | FORMES CRISTALLINES DE CALCIUM DE PITAVASTATINE (CRYSTALLINE FORMS OF PITAVASTATIN CALCIUM) | ⤷ Sign Up |
Japan | 2011201915 | CRYSTALLINE FORM OF PITAVASTATIN CALCIUM | ⤷ Sign Up |
Japan | 2014055185 | NOVEL AMORPHOUS FORM OF PITAVASTATIN CALCIUM | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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