DULOXETINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Duloxetine Hydrochloride, and what generic alternatives are available?
Duloxetine Hydrochloride is a drug marketed by Actavis Elizabeth, Ajanta Pharma Ltd, Alembic, 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-three NDAs.
The generic ingredient in DULOXETINE HYDROCHLORIDE is duloxetine hydrochloride. There are forty-two drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Duloxetine Hydrochloride
A generic version of DULOXETINE HYDROCHLORIDE was approved as duloxetine hydrochloride by AUROBINDO PHARMA LTD on December 11th, 2013.
Summary for DULOXETINE HYDROCHLORIDE
US Patents: | 0 |
Applicants: | 23 |
NDAs: | 23 |
Finished Product Suppliers / Packagers: | 47 |
Raw Ingredient (Bulk) Api Vendors: | 118 |
Clinical Trials: | 354 |
Patent Applications: | 331 |
Formulation / Manufacturing: | see details |
DailyMed Link: | DULOXETINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for DULOXETINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Grünenthal GmbH | Phase 3 |
Institut Cancerologie de l'Ouest | Phase 3 |
Dr. Inge Winter | Phase 4 |
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
Anatomical Therapeutic Chemical (ATC) Classes for DULOXETINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for DULOXETINE HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
CYMBALTA | Delayed-release Capsules | duloxetine hydrochloride | 40 mg | 021427 | 1 | 2012-05-10 |
CYMBALTA | Delayed-release Capsules | duloxetine hydrochloride | 20 mg, 30 mg and 60 mg | 021427 | 16 | 2008-08-04 |
US Patents and Regulatory Information for DULOXETINE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Zydus Pharms | DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 090728-002 | Jan 8, 2014 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Macleods Pharms Ltd | DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 204815-002 | Mar 23, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Hetero Labs Ltd Iii | DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 204343-003 | Aug 3, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |