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Duloxetine hydrochlorideis the generic ingredient in three branded drugs marketed by Lilly, Sun Pharma Global, Actavis Elizabeth, Ajanta Pharma Ltd, Alembic Pharms Ltd, Alkem Labs Ltd, Anchen Pharms, Apotex, Aurobindo Pharma Ltd, Breckenridge, Cspc Ouyi, Hetero Labs Ltd Iii, Inventia, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Prinston Inc, Qingdao Baheal Pharm, Sun Pharm, Sunshine, Teva Pharms Usa, Torrent, Yaopharma Co Ltd, Zydus Hlthcare, and Zydus Pharms, and is included in twenty-five NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.
Duloxetine hydrochloride has one patent family member in one country.
There are forty-two drug master file entries for duloxetine hydrochloride. Forty-seven suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for duloxetine hydrochloride
|Drug Master File Entries:||42|
|Finished Product Suppliers / Packagers:||47|
|Raw Ingredient (Bulk) Api Vendors:||109|
|Formulation / Manufacturing:||see details|
|What excipients (inactive ingredients) are in duloxetine hydrochloride?||duloxetine hydrochloride excipients list|
|DailyMed Link:||duloxetine hydrochloride at DailyMed|
Recent Clinical Trials for duloxetine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|CSPC ZhongQi Pharmaceutical Technology Co., Ltd.||Phase 2|
|Yan Yang, MD, Ph.D||Phase 2|
|Mayo Clinic||Phase 4|
Generic filers with tentative approvals for DULOXETINE HYDROCHLORIDE
|Applicant||Application No.||Strength||Dosage Form|
|⤷ Free Forever Trial||⤷ Free Forever Trial||EQ 60MG BASE||CAPSULE, DELAYED RELEASE; ORAL|
|⤷ Free Forever Trial||⤷ Free Forever Trial||EQ 30MG BASE||CAPSULE, DELAYED RELEASE; ORAL|
|⤷ Free Forever Trial||⤷ Free Forever Trial||EQ 20MG BASE||CAPSULE, DELAYED RELEASE; ORAL|
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 duloxetine hydrochloride
|Drug Class||Serotonin and Norepinephrine Reuptake Inhibitor |
|Mechanism of Action||Norepinephrine Uptake Inhibitors |
Serotonin Uptake Inhibitors
Medical Subject Heading (MeSH) Categories for duloxetine hydrochloride
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|0273658||2005C/001||Belgium||⤷ Free Forever Trial||PRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 20040811|
|0273658||C300171||Netherlands||⤷ Free Forever Trial||PRODUCT NAME: DULOXETINE EN FARMACEUTISCH AANVAARDBARE ZUURADDITIEZOUTEN DAARVAN, EN IN HET BIJZONDER DULOXETINE HYDROCHLORIDE; NATL REGISTRATION NO/DATE: EU/1/04/280/001-006 20040811|
|0273658||SPC/GB05/003||United Kingdom||⤷ Free Forever Trial||PRODUCT NAME: DULOXETINE AND PHARMACUETICALLY ACCEPTABLE ACID ADDITION SALTS THEREOF, AND IN PARTICULAR DULOXETINE HYDROCHLORIDE; REGISTERED: UK EU/1/04/280/001 20040811; UK EU/1/04/280/002 20040811; UK EU/1/04/280/003 20040811; UK EU/1/04/280/004 20040811; UK EU/1/04/280/005 20040811; UK EU/1/04/280/006 20040811|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|
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