LIVALO Drug Patent Profile
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When do Livalo patents expire, and when can generic versions of Livalo launch?
Livalo is a drug marketed by Kowa Co and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has fifty-three patent family members in seventeen countries.
The generic ingredient in LIVALO is pitavastatin calcium. There are fifteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the pitavastatin calcium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Livalo
A generic version of LIVALO was approved as pitavastatin calcium by AUROBINDO PHARMA on December 20th, 2016.
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Questions you can ask:
- What is the 5 year forecast for LIVALO?
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- What is Average Wholesale Price for LIVALO?
Summary for LIVALO
International Patents: | 53 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 107 |
Clinical Trials: | 23 |
Patent Applications: | 4,204 |
Drug Prices: | Drug price information for LIVALO |
Drug Sales Revenues: | Drug sales revenues for LIVALO |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LIVALO |
What excipients (inactive ingredients) are in LIVALO? | LIVALO excipients list |
DailyMed Link: | LIVALO at DailyMed |
Recent Clinical Trials for LIVALO
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Amgen | Phase 4 |
Brigham and Women's Hospital | Phase 4 |
National Heart, Lung, and Blood Institute (NHLBI) | Phase 3 |
Pharmacology for LIVALO
Drug Class | HMG-CoA Reductase Inhibitor |
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Paragraph IV (Patent) Challenges for LIVALO
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 LIVALO
LIVALO is protected by two US patents.
Patents protecting LIVALO
Hyperlipemia therapeutic agent
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Crystalline forms of pitavastatin calcium
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-001 | Aug 3, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-002 | Aug 3, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 | ||
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-002 | Aug 3, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 LIVALO
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-002 | 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 | 022363-001 | 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 LIVALO
See the table below for patents covering LIVALO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2342609 | ⤷ 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 |
Germany | 202004021379 | ⤷ Sign Up | |
Taiwan | 200420541 | Crystalline forms | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |