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DULOXETINE HYDROCHLORIDE Drug Profile
When do Duloxetine Hydrochloride patents expire, and when can generic versions of Duloxetine Hydrochloride launch?
Duloxetine Hydrochloride is a drug marketed by Actavis Elizabeth, Ajanta Pharma Ltd, Alembic Pharms Ltd, Alkem Labs Ltd, Anchen Pharms, Apotex Inc, 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, Teva Pharms Usa, Torrent, Yaopharma Co Ltd, Zydus Hlthcare, and Zydus Pharms. and is included in twenty-two NDAs.
The generic ingredient in DULOXETINE HYDROCHLORIDE is duloxetine hydrochloride. There are forty-two drug master file entries for this compound. Forty-five suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the duloxetine hydrochloride profile page.
Summary for DULOXETINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 22 |
| NDAs: | 22 |
| Suppliers / Packagers: | 44 |
| Bulk Api Vendors: | 93 |
| Clinical Trials: | 290 |
| Patent Applications: | 4,057 |
| 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 |
|---|---|
| Beijing Tiantan Hospital | Phase 4 |
| Alliance for Clinical Trials in Oncology | Phase 2/Phase 3 |
| National Cancer Institute (NCI) | Phase 2/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
Synonyms for DULOXETINE HYDROCHLORIDE
| (+)-(S)-N-methyl-.gamma.-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride |
| (+)-(S)-N-Methyl-3-(1-naphthyloxy)-3-(2-thienyl)propanamine hydrochloride |
| (+)-(S)-N-Methyl-gamma-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride |
| (+)-N-methyl-gamma-(1-napthlenloxy)-2-thiophenepropan-amine hydrochloride |
| (3S)-N-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propan-1-amine hydrochloride |
| (3S)-N-methyl-3-(naphthalen-1-yloxy)-3-(2-thienyl)propan-1-amine hydrochloride |
| (3S)-N-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amin hydrochloride. |
| (3S)-N-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amine hydrochloride |
| (3S)-N-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amine;hydrochloride |
| (S)-(+)-DULOXETINE HYDROCHLORIDE |
| (S)-(+)-N-methyl-3-(1-naphthalenyloxy)-3-(2-thienyl) propanamine hydrochloride |
| (S)-(+)-N-Methyl-3-(1-naphthyloxy)-3-(2-thienyl)propylamine Hydrochloride |
| (S)-Duloxetine (hydrochloride) |
| (S)-Duloxetine HCl |
| (S)-duloxetine hydrochloride |
| (S)-Duloxetine hydrochloride, >=98% (HPLC) |
| (S)-N-METHYL-3-(NAPHTHALEN-1-YLOXY)-3-(THIOPHEN-2-YL)PROPAN-1-AMINE HCL |
| (S)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine hydrochloride |
| 136434-34-9 |
| 2-Thiophenepropanamine, N-methyl-gamma-(1-naphthalenyloxy)-, hydrochloride, (gammaS)- |
| 2-Thiophenepropanamine, N-methyl-gamma-(1-naphthalenyloxy)-, hydrochloride, (S)- |
| 434D349 |
| 9044SC542W |
| AB0008489 |
| AB2000488 |
| AB23771 |
| AC-924 |
| AC1L1U0N |
| AC1Q3DMM |
| AK-72899 |
| AKOS016340453 |
| AN-253 |
| ANW-52464 |
| API0002507 |
| Ariclaim |
| AX8017673 |
| BFFSMCNJSOPUAY-LMOVPXPDSA-N |
| BR-72899 |
| C18H19NOS.HCl |
| C18H20ClNOS |
| CAS-136434-34-9 |
| CCG-101106 |
| CD0196 |
| CHEBI:31526 |
| CHEMBL1200328 |
| CPD000469136 |
| CS-1993 |
| Cymbalta |
| Cymbalta (TN) |
| Cymbalta|||Dulane 20|||LY 248686 HCl |
| D-170 |
| D01179 |
| D4223 |
| DSSTox_CID_26443 |
| DSSTox_GSID_46443 |
| DSSTox_RID_81618 |
| DTXSID9046443 |
| Dulane 20 |
| Duloxetine (hydrochloride) |
| Duloxetine for system suitability, European Pharmacopoeia (EP) Reference Standard |
| Duloxetine HCl |
| Duloxetine HCl (Cymbalta) |
| Duloxetine hydrochloride (JAN/USAN) |
| Duloxetine hydrochloride [USAN] |
| Duloxetine Hydrochloride 1.0 mg/ml in Methanol (as free base) |
| Duloxetine hydrochloride, European Pharmacopoeia (EP) Reference Standard |
| Duloxetine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material |
| Duloxetine hydrochloride, United States Pharmacopeia (USP) Reference Standard |
| duloxetine hydrochlorise |
| Duloxetine-D3 hydrochloride solution, 100 mug/mL in methanol (as free base), ampule of 1 mL, certified reference material |
| Duloxetine, HCl |
| EBD2816 |
| EBD29778 |
| FT-0648818 |
| HY-B0161A |
| J10476 |
| KB-50492 |
| KS-1168 |
| LS-172959 |
| LY 248686 HCl |
| LY-248686 |
| LY-264453 |
| LY248686 HCl |
| methyl[(3S)-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl]amine hydrochloride |
| MLS001401452 |
| MLS006010054 |
| MolPort-003-666-661 |
| NC00356 |
| NCGC00164559-01 |
| NCGC00164559-03 |
| NSC-744012 |
| NSC-759112 |
| NSC744012 |
| NSC759112 |
| Pharmakon1600-01505387 |
| PubChem1909 |
| Q-102508 |
| S-4928 |
| s2084 |
| SAM001246523 |
| SC-00924 |
| SMR000469136 |
| ST24026653 |
| SW197393-3 |
| TC-141209 |
| Tox21_112188 |
| Tox21_112188_1 |
| UNII-9044SC542W |
| Xeristar |
| Yentreve (TN) |
Paragraph IV (Patent) Challenges for DULOXETINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CYMBALTA | CAPSULE, DELAYED REL PELLETS;ORAL | duloxetine hydrochloride | 021427 | 2012-05-10 |
| CYMBALTA | CAPSULE, DELAYED REL PELLETS;ORAL | duloxetine hydrochloride | 021427 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Macleods Pharms Ltd | DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 204815-002 | Mar 23, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Hetero Labs Ltd Iii | DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 204343-003 | Aug 3, 2016 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Qingdao Baheal Pharm | DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 210599-001 | Apr 17, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Torrent | DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 090774-003 | Dec 11, 2013 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Marksans Pharma | DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 090723-003 | Dec 11, 2013 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
