SERTRALINE HYDROCHLORIDE Drug Patent Profile
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When do Sertraline Hydrochloride patents expire, and when can generic versions of Sertraline Hydrochloride launch?
Sertraline Hydrochloride is a drug marketed by Almatica, ACI, Aurobindo Pharma, Ranbaxy Labs Ltd, Accord Hlthcare, Anda Repository, Ascent Pharms Inc, Chartwell Molecular, Fosun Pharma, Granules, Heritage Pharma Avet, Hikma Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Mylan, Mylan Pharms Inc, Oxford Pharms, Reyoung, Sciegen Pharms Inc, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Torrent Pharms, Viwit Pharm, and Zydus. and is included in thirty-one NDAs.
The generic ingredient in SERTRALINE HYDROCHLORIDE is sertraline hydrochloride. There are twenty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Sertraline Hydrochloride
A generic version of SERTRALINE HYDROCHLORIDE was approved as sertraline hydrochloride by ACI on June 30th, 2006.
Summary for SERTRALINE HYDROCHLORIDE
US Patents: | 0 |
Applicants: | 25 |
NDAs: | 31 |
Finished Product Suppliers / Packagers: | 45 |
Raw Ingredient (Bulk) Api Vendors: | 147 |
Clinical Trials: | 327 |
Patent Applications: | 5,433 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in SERTRALINE HYDROCHLORIDE? | SERTRALINE HYDROCHLORIDE excipients list |
DailyMed Link: | SERTRALINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for SERTRALINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Texas at Austin | Phase 4 |
Westfälische Wilhelms-Universität Münster | Phase 4 |
Lehigh University | Phase 4 |
Pharmacology for SERTRALINE HYDROCHLORIDE
Drug Class | Serotonin Reuptake Inhibitor |
Mechanism of Action | Cytochrome P450 2D6 Inhibitors Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for SERTRALINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for SERTRALINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for SERTRALINE HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ZOLOFT | Tablets | sertraline hydrochloride | 150 mg and 200 mg | 019839 | 1 | 2005-11-09 |
ZOLOFT | Oral Concentrate | sertraline hydrochloride | 20 mg/mL | 020990 | 1 | 2003-12-09 |