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 Aurobindo Pharma, Lupin Ltd, Mylan, Orient Pharma Co Ltd, Sawai Usa, and Zydus Pharms. and is included in six NDAs.
The generic ingredient in PITAVASTATIN CALCIUM is pitavastatin calcium. There are fifteen drug master file entries for this compound. Eight 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.
Summary for PITAVASTATIN CALCIUM
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 |
| Chonnam 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
PITAVASTATIN CALCIUM is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting PITAVASTATIN CALCIUM
PATENT CHALLENGE
Exclusivity Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma | PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 206015-001 | Dec 20, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Zydus Pharms | PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 206047-003 | Feb 22, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mylan | PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 206070-001 | Apr 4, 2019 | 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 |
