PRAVASTATIN SODIUM Drug Patent Profile
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When do Pravastatin Sodium patents expire, and what generic alternatives are available?
Pravastatin Sodium is a drug marketed by Accord Hlthcare, Apnar Pharma Lp, Apotex, Aurobindo Pharma, Biocon Pharma, Chartwell Rx, Cipla, Dr Reddys Labs Inc, Glenmark Generics, Hisun Pharm Hangzhou, Mylan, Mylan Pharms Inc, Pliva Hrvatska Doo, Ranbaxy Labs Ltd, Teva, Teva Pharms, Watson Labs, and Zydus Pharms Usa. and is included in eighteen NDAs.
The generic ingredient in PRAVASTATIN SODIUM is pravastatin sodium. There are sixteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the pravastatin sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Pravastatin Sodium
A generic version of PRAVASTATIN SODIUM was approved as pravastatin sodium by TEVA on April 24th, 2006.
Summary for PRAVASTATIN SODIUM
Recent Clinical Trials for PRAVASTATIN SODIUM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Maryland, Baltimore | Phase 4 |
University of Thessaly | N/A |
University of Southern California | Phase 2 |
Pharmacology for PRAVASTATIN SODIUM
Drug Class | HMG-CoA Reductase Inhibitor |
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for PRAVASTATIN SODIUM
Anatomical Therapeutic Chemical (ATC) Classes for PRAVASTATIN SODIUM
Paragraph IV (Patent) Challenges for PRAVASTATIN SODIUM
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
PRAVACHOL | Tablets | pravastatin sodium | 30 mg | 019898 | 1 | 2005-06-01 |
US Patents and Regulatory Information for PRAVASTATIN SODIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan | PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 077013-002 | Oct 23, 2006 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Dr Reddys Labs Inc | PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 076714-004 | Dec 28, 2007 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Pliva Hrvatska Doo | PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 077730-002 | Nov 21, 2006 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Watson Labs | PRAVASTATIN SODIUM | pravastatin sodium | TABLET;ORAL | 076939-004 | Oct 23, 2006 | 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 |