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PAROXETINE HYDROCHLORIDE Drug Profile
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» See Plans and PricingWhen do Paroxetine Hydrochloride patents expire, and what generic alternatives are available?
Paroxetine Hydrochloride is a drug marketed by Apotex Inc, Lannett Co Inc, Lupin Ltd, Mylan, Sciecure Pharma Inc, Apotex, Aurobindo Pharma, Jubilant Generics, Mylan Pharms Inc, Oxford Pharms, Roxane, Sun Pharm Inds Inc, Teva, Teva Pharms, Upsher Smith Labs, and Zydus Pharms Usa. and is included in eighteen NDAs.
The generic ingredient in PAROXETINE HYDROCHLORIDE is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Paroxetine Hydrochloride
A generic version of PAROXETINE HYDROCHLORIDE was approved as paroxetine hydrochloride by APOTEX on July 30th, 2003.
Summary for PAROXETINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 16 |
| NDAs: | 18 |
| Suppliers / Packagers: | 36 |
| Bulk Api Vendors: | 87 |
| Clinical Trials: | 236 |
| Patent Applications: | 812 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PAROXETINE HYDROCHLORIDE |
| DailyMed Link: | PAROXETINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for PAROXETINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Spaulding Clinical Research LLC | Phase 1 |
| Food and Drug Administration (FDA) | Phase 1 |
| Leiden University Medical Center | Phase 1 |
Recent Litigation for PAROXETINE HYDROCHLORIDE
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ADAMAS PHARMA, LLC v. SANDOZ INC. | 2018-05-10 |
| SEBELA INTERNATIONAL LIMITED v. PRINSTON PHARMACEUTICAL, INC. | 2017-07-06 |
| Sebela International Limited v. ACTAVIS LABORATORIES FL, INC. | 2017-06-28 |
Pharmacology for PAROXETINE HYDROCHLORIDE
| Drug Class | Serotonin Reuptake Inhibitor |
| Mechanism of Action | Serotonin Uptake Inhibitors |
Synonyms for PAROXETINE HYDROCHLORIDE
| (-)-(3S,4R)-4-(p-Fluorophenyl)-3-((3,4-methylenedioxy)phenoxy)-methyl)piperidine hydrochloride |
| (-)-trans-4-(-4-fluorophenyl)-3-(3,4-methylenedioxy-phenoxymethyl)-piperidine hydrochloride |
| (-)-trans-4-(-4-fluorophenyl)-3-(3,4-methylenedioxyphenoxymethyl)-piperidine hydrochloride |
| (-)-trans-4-(4-fluorophenyl)-3-(3,4-methylene dioxyphenoxymethyl)-piperidine hydrochloride |
| (-)-trans-paroxetine hydrochloride |
| (-)TRANS-3-[(1,3-BENZODIOXOL-5-YLOXY) METHYL]-4-(4-FLUOROPHENYL) PAROXETINE HYDROCHLORIDE |
| (3S-trans)-3-((1,3-benzodioxol-5-yloxy)methyl)-4-(4-fluorophenyl)-piperidine hydrochloride |
| (3S-TRANS)-3-[(1,3-BENZODIOXOL-5-YLOXY)METHYL]-4-(4-FLUOROPHENYL)PIPERIDINE HYDROCHLORIDE |
| (3S-trans)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine hydrochloride hemihydrate |
| (3S,4R)-(-)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine Hydrochloride |
| (3S,4R)-3-((BENZO[D][1,3]DIOXOL-5-YLOXY)METHYL)-4-(4-FLUOROPHENYL)PIPERIDINE HCL |
| (3S,4R)-3-((Benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4-fluorophenyl)piperidine hydrochloride |
| (3S,4R)-3-(1,3-benzodioxol-5-yloxymethyl)-4-(4-fluorophenyl)piperidine;hydrochloride |
| (3S,4R)-3-[(1,3-BENZODIOXOL-5-YLOXY)METHYL]-4-(4-FLUOROPHENYL)-PIPERIDINE HYDROCHLORIDE |
| (3S,4R)-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine hydrochloride |
| (3S,4R)-3-[(2H-1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine hydrochloride |
| (S)-3-(BENZO[1,3]DIOXOL-5-YLOXYMETHYL)-4-(4-FLUORO-PHENYL)-PIPERIDINE HYDROCHLORIDE |
| 110429-35-1 |
| 110429-35-1(hemihydrate) 61869-08-7 |
| 3I3T11UD2S |
| 78246-49-8 |
| AB0008509 |
| AB1004558 |
| AK-49032 |
| AKOS015849162 |
| AKOS015907108 |
| ANW-49202 |
| API0003757 |
| Aropax |
| Aropax 20 |
| AX8022605 |
| BG0380 |
| BR-49032 |
| BRL 29060 hydrochloride |
| BRL 29060A |
| BRL-29060A |
| BRL29060 hydrochloride |
| BRL29060A |
| C19H20FNO3.HCl |
| C19H21ClFNO3 |
| CCG-39866 |
| CHEBI:7944 |
| CHEMBL1708 |
| CS-2611 |
| D05374 |
| DTXSID50228914 |
| EU-0100095 |
| FG-7051 |
| GELRVIPPMNMYGS-RVXRQPKJSA-N |
| H29P351 |
| HMS1922B11 |
| HSDB 7175 |
| HY-B0492 |
| J10285 |
| KS-00000JOT |
| KS-5097 |
| LP00095 |
| LS-114251 |
| MFCD03658863 |
| MLS002222322 |
| NCGC00093597-01 |
| NCGC00260780-01 |
| NSC-758654 |
| NSC758654 |
| P1977 |
| Paroxat |
| paroxatene |
| PAROXETIN HYDROCHLORIDE |
| paroxetine (hydrochloride) |
| paroxetine (Paxil) |
| Paroxetine Hcl |
| Paroxetine hydrochloride (USP) |
| Paroxetine hydrochloride [USAN] |
| Paroxetine hydrochloride [USP] |
| Paroxetine Hydrochloride Anhydrous |
| Paroxetine hydrochloride hemihydrate |
| Paroxetine hydrochloride hemihydrate (MW = 374.83) |
| Paroxetine or other medication - algorithm used |
| Paroxetine, HCl |
| Paxil |
| Paxil (TN) |
| Pharmakon1600-01504085 |
| Piperidine, 3-((1,3-benzodioxol-5-yloxy)methyl)-4-(4-fluorophenyl)-, hydrochloride, (3S-trans)- |
| Piperidine, 3-((1,3-benzodioxol-5-yloxy)methyl)-4-(4-fluorophenyl)-, hydrochloride, (3S,4R)- |
| Piperidine, 3-((1,3-benzodioxol-5-yloxy)methyl)-4-(4-fluorophenyl)-, hydrochloride,(3S-trans)- |
| Q27257245 |
| S-2491 |
| S3005 |
| SCHEMBL33348 |
| SDB 7175 |
| Seroxat |
| SMR001307264 |
| SPECTRUM1504085 |
| SR-01000759305 |
| SR-01000759305-6 |
| ST24025708 |
| SW197457-4 |
| TC-137947 |
| Tox21_500095 |
| UNII-3I3T11UD2S |
| YF10047 |
| Z1741971218 |
Paragraph IV (Patent) Challenges for PAROXETINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PAXIL CR | TABLET, EXTENDED RELEASE;ORAL | paroxetine hydrochloride | 020936 | 2009-05-19 |
| PAXIL CR | TABLET, EXTENDED RELEASE;ORAL | paroxetine hydrochloride | 020936 | 2005-09-09 |
| PAXIL | SUSPENSION;ORAL | paroxetine hydrochloride | 020710 | 2005-02-10 |
| PAXIL | CAPSULE;ORAL | paroxetine hydrochloride | 020885 | |
| PAXIL | TABLET;ORAL | paroxetine hydrochloride | 020031 |
US Patents and Regulatory Information for PAROXETINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Roxane | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 078026-004 | Jun 29, 2007 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Mylan Pharms Inc | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 075716-003 | Mar 8, 2004 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Teva | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 076618-004 | Aug 15, 2005 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Zydus Pharms Usa | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 077584-003 | Mar 7, 2007 | 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 |
