HYDROCODONE BITARTRATE Drug Patent Profile
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Which patents cover Hydrocodone Bitartrate, and what generic alternatives are available?
Hydrocodone Bitartrate is a drug marketed by Alvogen, Mallinckrodt, Mikart, Chartwell, Genus, Mallinckrodt Inc, Nesher Pharms, Pharm Assoc, Tris Pharma Inc, Vintage Pharms, Wes Pharma Inc, Abhai Llc, Able, Actavis Labs Fl Inc, Amneal Pharms, Amneal Pharms Ny, Apil, Ascent Pharms Inc, Aurolife Pharma Llc, Barr, Caraco, Elite Labs Inc, Endo Operations, Epic Pharma Llc, Granules, Halsey, Ivax Pharms, Lannett Co Inc, Mutual Pharm, Novel Labs Inc, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Rhodes Pharms, Sanaluz, Sandoz, Specgx Llc, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Ucb Inc, Upsher Smith Labs, Usl Pharma, Vintage Pharms Llc, Watson Labs, Watson Labs Florida, Lgm Pharma, Acella, Actavis Mid Atlantic, Ivax Sub Teva Pharms, Nostrum Labs Inc, Padagis Us, Sciegen Pharms Inc, Wockhardt Bio Ag, Ani Pharms, Teva, and Mayne Pharma Inc. and is included in one hundred and fifty-five NDAs.
The generic ingredient in HYDROCODONE BITARTRATE is chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride. There are twenty-nine drug master file entries for this compound. Additional details are available on the chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride profile page.
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Summary for HYDROCODONE BITARTRATE
US Patents: | 0 |
Applicants: | 57 |
NDAs: | 155 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 23 |
Clinical Trials: | 30 |
Patent Applications: | 135 |
Drug Prices: | Drug price information 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
Sponsor | Phase |
---|---|
Medpace, Inc. | Phase 1 |
Ohio Third Frontier | Phase 1 |
Charles River Labs | Phase 1 |
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
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
HYSINGLA ER | Extended-release Tablets | hydrocodone bitartrate | 30 mg, 40 mg, 80 mg, and 100 mg | 206627 | 1 | 2015-05-08 |
HYSINGLA ER | Extended-release Tablets | hydrocodone bitartrate | 20 mg, 60 mg, and 120 mg | 206627 | 1 | 2015-04-15 |
ZOHYDRO ER | Extended-release Capsules | hydrocodone bitartrate | 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg | 202880 | 1 | 2014-02-26 |