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, Apotex, Aurobindo Pharma Ltd, Breckenridge, Cspc Ouyi, Endo Operations, 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. Fifty 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.
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Questions you can ask:
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Summary for DULOXETINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 23 |
| NDAs: | 23 |
| Finished Product Suppliers / Packagers: | 49 |
| Raw Ingredient (Bulk) Api Vendors: | 118 |
| Clinical Trials: | 356 |
| Patent Applications: | 331 |
| DailyMed Link: | DULOXETINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for DULOXETINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute, Egypt | Phase 4 |
| Beni-Suef University | Phase 2 |
| Grünenthal GmbH | Phase 3 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Macleods Pharms Ltd | DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 204815-002 | Mar 23, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hetero Labs Ltd Iii | DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 204343-003 | Aug 3, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Qingdao Baheal Pharm | DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 210599-001 | Apr 17, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa | DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 090783-003 | Dec 11, 2013 | DISCN | 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 |
