LIVALO Drug Patent Profile
✉ Email this page to a colleague
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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for LIVALO?
- What are the global sales for LIVALO?
- 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
| 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 | ||
| Kowa Co | LIVALO | pitavastatin calcium | TABLET;ORAL | 022363-003 | Aug 3, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 | ||
| >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 |
| 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 | 022363-003 | 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 |
|---|---|---|---|
| Poland | 376557 | Postacie krystaliczne pitawastatyny wapnia (CRYSTALLINE FORMS OF PITAVASTATIN CALCIUM) | ⤷ Sign Up |
| Japan | 2019031574 | 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 FORMS OF PITAVASTATIN CALCIUM) | ⤷ Sign Up |
| Canada | 1336714 | MEVALONOLACTONE DE TYPE QUINOLEINE UTILISEE COMME INHIBITEURS DE LA BIOSYNTHESE DU CHOLESTEROL (QUINOLINE TYPE MEVALONOLACTONE INHIBITORS OF CHOLESTEROL BIOSYNTHESIS) | ⤷ Sign Up |
| European Patent Office | 2500339 | Formes cristallines de calcium de pitavastatine (Crystalline forms of pitavastatin calcium) | ⤷ Sign Up |
| Germany | 3852243 | ⤷ Sign Up | |
| Japan | 2014062115 | NOVEL CRYSTALLINE FORM OF PITAVASTATIN CALCIUM | ⤷ Sign Up |
| Japan | 2014024848 | NEW CRYSTALLINE FORMS OF PITAVASTATIN CALCIUM | ⤷ Sign Up |
| >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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
