PITAVASTATIN CALCIUM Drug Patent Profile
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When do Pitavastatin Calcium patents expire, and when can generic versions of Pitavastatin Calcium launch?
Pitavastatin Calcium is a drug marketed by 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 eight NDAs.
The generic ingredient in PITAVASTATIN CALCIUM 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 Pitavastatin Calcium
A generic version of PITAVASTATIN CALCIUM was approved as pitavastatin calcium by AUROBINDO PHARMA on December 20th, 2016.
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Summary for PITAVASTATIN CALCIUM
| US Patents: | 0 |
| Applicants: | 8 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 64 |
| Clinical Trials: | 2 |
| Patent Applications: | 3,854 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PITAVASTATIN CALCIUM |
| 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 |
| Ajou University School of Medicine | 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
PITAVASTATIN CALCIUM is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting PITAVASTATIN CALCIUM
PATENT CHALLENGE
Exclusivity 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms Ny | PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 205961-001 | Aug 20, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Orient Pharma Co Ltd | PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 205932-003 | Feb 3, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Pharms | PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 206047-003 | Feb 22, 2023 | 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 |
