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, Aurobindo Pharma, Ranbaxy Labs Ltd, Strides Pharma, Accord Hlthcare, Anda Repository, Appco, Ascent Pharms Inc, Chartwell Molecular, Granules, Heritage Pharma Avet, Hikma Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Mylan Pharms Inc, Norvium Bioscience, 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-nine 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 STRIDES PHARMA on June 30th, 2006.
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Questions you can ask:
- What is the 5 year forecast for SERTRALINE HYDROCHLORIDE?
- What are the global sales for SERTRALINE HYDROCHLORIDE?
- What is Average Wholesale Price for SERTRALINE HYDROCHLORIDE?
Summary for SERTRALINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 25 |
| NDAs: | 31 |
| Finished Product Suppliers / Packagers: | 46 |
| Raw Ingredient (Bulk) Api Vendors: | 147 |
| Clinical Trials: | 329 |
| Patent Applications: | 4,578 |
| 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 |
|---|---|
| Alberta Health services | Phase 2 |
| St. Justine's Hospital | Phase 2 |
| McMaster University | Phase 2 |
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 |
US Patents and Regulatory Information for SERTRALINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm Inds (in) | SERTRALINE HYDROCHLORIDE | sertraline hydrochloride | TABLET;ORAL | 078108-001 | Feb 6, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma Pharms | SERTRALINE HYDROCHLORIDE | sertraline hydrochloride | TABLET;ORAL | 077864-003 | Aug 10, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Heritage Pharma Avet | SERTRALINE HYDROCHLORIDE | sertraline hydrochloride | TABLET;ORAL | 077299-002 | Feb 6, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zydus | SERTRALINE HYDROCHLORIDE | sertraline hydrochloride | TABLET;ORAL | 077106-001 | Feb 6, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Lupin | SERTRALINE HYDROCHLORIDE | sertraline hydrochloride | TABLET;ORAL | 077670-002 | Feb 6, 2007 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
