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, 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: | 7,177 |
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 |
Eulji 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aurobindo Pharma | PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 206015-001 | Dec 20, 2016 | 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 | |||
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-003 | Aug 3, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Amneal Pharms Ny | PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 205961-002 | Aug 20, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-001 | Aug 3, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Mylan | PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 206070-001 | Apr 4, 2019 | 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 | 022363-003 | Aug 3, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-001 | 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 |
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-002 | Aug 3, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-001 | 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 | 2014205723 | ピタバスタチンカルシウムの新規な結晶質形態 (NEW CRYSTALLINE FORMS OF PITAVASTATIN CALCIUM) | ⤷ Sign Up |
Japan | 2014198743 | ピタバスタチンカルシウムの新規な結晶質形態 (NOVEL CRYSTALLINE FORMS OF PITAVASTATIN CALCIUM) | ⤷ Sign Up |
Poland | 376557 | Postacie krystaliczne pitawastatyny wapnia (CRYSTALLINE FORMS OF PITAVASTATIN CALCIUM) | ⤷ Sign Up |
Japan | 2020169196 | ピタバスタチンカルシウムの新規な結晶質形態 (NOVEL CRYSTALLINE FORMS OF PITAVASTATIN CALCIUM) | ⤷ Sign Up |
Japan | 2015172086 | ピタバスタチンカルシウムの新規なアモルファス形態 (NOVEL AMORPHOUS FORM OF PITAVASTATIN CALCIUM) | ⤷ Sign Up |
Denmark | 1715865 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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