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. Additional information is available in the individual branded drug profile pages.There are thirteen drug master file entries for pitavastatin calcium. Twelve suppliers are listed for this compound.
Summary for pitavastatin calcium
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 9 |
NDAs: | 9 |
Drug Master File Entries: | 13 |
Finished Product Suppliers / Packagers: | 12 |
Raw Ingredient (Bulk) Api Vendors: | 64 |
Clinical Trials: | 2 |
Patent Applications: | 7,185 |
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 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Orient Pharma Co Ltd | PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 205932-003 | Feb 3, 2017 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Zydus Pharms | PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 206047-001 | Feb 22, 2023 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Amneal Pharms Ny | PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 205961-001 | Aug 20, 2024 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Orient Pharma Co Ltd | PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 205932-002 | Feb 3, 2017 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
>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 | 5,753,675 | ⤷ Try for Free |
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-002 | Aug 3, 2009 | 6,465,477 | ⤷ Try for Free |
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-003 | Aug 3, 2009 | 5,753,675 | ⤷ Try for Free |
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-001 | Aug 3, 2009 | 5,753,675 | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Pitavastatin Calcium: Market Dynamics and Financial Trajectory
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