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Meloxicamis the generic ingredient in five branded drugs marketed by Lupin Ltd, Zyla, Baudax, Avondale Pharms, Tersera, Anda Repository, Apotex Inc, Aurobindo Pharma, Cipla, Cr Double Crane, Dr Reddys Labs Inc, Glenmark Generics, Heritage Pharma, Impax Labs Inc, Lupin Pharms, Mylan, Nostrum Labs Inc, Puracap Pharm, Roxane, Strides Pharma, Sun Pharm Inds Inc, Taro, Unichem, Yabao Pharm, Yung Shin Pharm, Zydus Pharms Usa, and Boehringer Ingelheim, and is included in twenty-eight NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.
Meloxicam has fifty-one patent family members in twenty-three countries.
There are twenty-two drug master file entries for meloxicam. Thirty-four suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for MELOXICAM
|Drug Master File Entries:||22|
|Suppliers / Packagers:||34|
|Bulk Api Vendors:||126|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends for MELOXICAM|
|Drug Sales Revenues:||Drug sales revenues for MELOXICAM|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for MELOXICAM|
|DailyMed Link:||MELOXICAM at DailyMed|
Recent Clinical Trials for MELOXICAM
Identify potential brand extensions & 505(b)(2) entrants
|Daewoong Pharmaceutical Co. LTD.||Phase 1|
|Beijing Tongren Hospital||Phase 1|
|Axsome Therapeutics, Inc.||Phase 3|
Generic filers with tentative approvals for MELOXICAM
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 MELOXICAM
|Drug Class||Nonsteroidal Anti-inflammatory Drug |
|Mechanism of Action||Cyclooxygenase Inhibitors |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Heritage Pharma||MELOXICAM||meloxicam||TABLET;ORAL||077936-001||Jul 19, 2006||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Cipla||MELOXICAM||meloxicam||TABLET;ORAL||077929-002||Jul 19, 2006||AB||RX||No||No||Start Trial||Start Trial||Start Trial|
|Mylan||MELOXICAM||meloxicam||TABLET;ORAL||077934-002||Jul 20, 2006||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Patent No.||Patent Expiration|
|Avondale Pharms||MOBIC||meloxicam||SUSPENSION;ORAL||021530-001||Jun 1, 2004||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
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