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Hydrocodone bitartrateis the generic ingredient in ten branded drugs marketed by Alvogen, Recro Gainesville, Alvogen Pine Brook, Purdue Pharma Lp, Teva Branded Pharm, Actavis Labs Fl Inc, Amneal Pharms Ny, Ani Pharms, Aurolife Pharma Llc, Nostrum Labs Inc, Sun Pharm Inds Inc, Teva, Abbvie, Alpharma Us Pharms, Mayne Pharma Inc, Padagis Us, Torrent, Tris Pharma Inc, and Persion, and is included in twenty NDAs. There are forty-five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.
Hydrocodone bitartrate has six hundred and twelve patent family members in forty-nine countries.
There are twenty-three drug master file entries for hydrocodone bitartrate. Two suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for hydrocodone bitartrate
|Drug Master File Entries:||23|
|Finished Product Suppliers / Packagers:||2|
|Raw Ingredient (Bulk) Api Vendors:||14|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends for hydrocodone bitartrate|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for hydrocodone bitartrate|
|What excipients (inactive ingredients) are in hydrocodone bitartrate?||hydrocodone bitartrate excipients list|
|DailyMed Link:||hydrocodone bitartrate at DailyMed|
Recent Clinical Trials for hydrocodone bitartrate
Identify potential brand extensions & 505(b)(2) entrants
|Sun Pharma Advanced Research Company Limited||Phase 1|
|Grünenthal GmbH||Phase 1|
|Purdue Pharma LP||Phase 2|
Generic filers with tentative approvals for HYDROCODONE BITARTRATE
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 hydrocodone bitartrate
|Drug Class||Opioid Agonist |
|Mechanism of Action||Opioid Agonists |
Medical Subject Heading (MeSH) Categories for hydrocodone bitartrate
Anatomical Therapeutic Chemical (ATC) Classes for hydrocodone bitartrate
Paragraph IV (Patent) Challenges for HYDROCODONE BITARTRATE
|Country||Patent Number||Estimated Expiration|
|European Patent Office||2384754||⤷ Free Forever Trial|
|Poland||2692341||⤷ Free Forever Trial|
|Montenegro||02874||⤷ Free Forever Trial|
|China||101010071||⤷ Free Forever Trial|
|Norway||20061055||⤷ Free Forever Trial|
|Japan||5069300||⤷ Free Forever Trial|
|>Country||>Patent Number||>Estimated Expiration|
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