PITAVASTATIN CALCIUM - Generic Drug Details
✉ Email this page to a colleague
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, Lupin Ltd, Mylan, Orient Pharma Co Ltd, Sawai Usa, and Zydus Pharms, and is included in seven 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. Eight suppliers are listed for this compound.
Summary for PITAVASTATIN CALCIUM
International Patents: | 53 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 7 |
NDAs: | 7 |
Drug Master File Entries: | 13 |
Finished Product Suppliers / Packagers: | 8 |
Raw Ingredient (Bulk) Api Vendors: | 64 |
Clinical Trials: | 2 |
Patent Applications: | 23 |
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 |
Eulji University Hospital | Phase 4 |
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 | 205955-002 | Feb 3, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Zydus Pharms | PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 206047-002 | Feb 22, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-003 | Aug 3, 2009 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Sawai Usa | PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 205955-003 | Feb 3, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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 | ⤷ Try a Trial | ⤷ Try a Trial |
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-003 | Aug 3, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-002 | Aug 3, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-003 | Aug 3, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PITAVASTATIN CALCIUM
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 100374422 | ⤷ Try a Trial | |
Japan | 5500305 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2005079797 | ⤷ Try a Trial | |
Taiwan | I485135 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.