PRAVASTATIN SODIUM - Generic Drug Details
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What are the generic drug sources for pravastatin sodium and what is the scope of freedom to operate?
Pravastatin sodium
is the generic ingredient in two branded drugs marketed by Bristol Myers Squibb, Accord Hlthcare, Apnar Pharma Lp, Apotex, Aurobindo Pharma, Biocon Pharma, Chartwell Rx, Cipla, Dr Reddys Labs Inc, Glenmark Pharms Ltd, Hisun Pharm Hangzhou, Norvium Bioscience, Pliva Hrvatska Doo, Ranbaxy Labs Ltd, Teva, Teva Pharms, Watson Labs, and Zydus Pharms Usa, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.There are fifteen drug master file entries for pravastatin sodium. Forty-one suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for PRAVASTATIN SODIUM
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 18 |
NDAs: | 19 |
Drug Master File Entries: | 15 |
Finished Product Suppliers / Packagers: | 41 |
Raw Ingredient (Bulk) Api Vendors: | 80 |
Clinical Trials: | 30 |
Patent Applications: | 7,600 |
Drug Prices: | Drug price trends for PRAVASTATIN SODIUM |
Drug Sales Revenues: | Drug sales revenues for PRAVASTATIN SODIUM |
What excipients (inactive ingredients) are in PRAVASTATIN SODIUM? | PRAVASTATIN SODIUM excipients list |
DailyMed Link: | PRAVASTATIN SODIUM at DailyMed |
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 |
Generic filers with tentative approvals for PRAVASTATIN SODIUM
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 80MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 40MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 20MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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
Expired US Patents for PRAVASTATIN SODIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bristol Myers Squibb | PRAVACHOL | pravastatin sodium | TABLET;ORAL | 019898-008 | Dec 18, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | PRAVACHOL | pravastatin sodium | TABLET;ORAL | 019898-008 | Dec 18, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | PRAVACHOL | pravastatin sodium | TABLET;ORAL | 019898-004 | Mar 22, 1993 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | PRAVACHOL | pravastatin sodium | TABLET;ORAL | 019898-002 | Oct 31, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | PRAVACHOL | pravastatin sodium | TABLET;ORAL | 019898-002 | Oct 31, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | PRAVACHOL | pravastatin sodium | TABLET;ORAL | 019898-003 | Oct 31, 1991 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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