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Paroxetine hydrochloride - Generic Drug Details
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What are the generic sources for paroxetine hydrochloride and what is the scope of freedom to operate?
Paroxetine hydrochloride
is the generic ingredient in four branded drugs marketed by Apotex Technologies, Apotex Inc, Lannett Co Inc, Lupin Ltd, Mylan, Sciecure Pharma Inc, Prinston 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 twenty-three NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Paroxetine hydrochloride has one hundred and fifty-seven patent family members in thirty-eight countries.
There are thirty drug master file entries for paroxetine hydrochloride. Forty suppliers are listed for this compound.
Summary for paroxetine hydrochloride
| International Patents: | 157 |
| US Patents: | 1 |
| Tradenames: | 4 |
| Applicants: | 18 |
| NDAs: | 23 |
| Drug Master File Entries: | 30 |
| Suppliers / Packagers: | 40 |
| Bulk Api Vendors: | 87 |
| Clinical Trials: | 234 |
| Patent Applications: | 1,244 |
| 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 |
|---|---|
| Boston Medical Group | N/A |
| Noam Soreni | Phase 3 |
| Central South University | N/A |
Recent Litigation for paroxetine hydrochloride
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| SEBELA INTERNATIONAL LIMITED v. PRINSTON PHARMACEUTICAL, INC. | 2017-07-06 |
| IN RE SEBELA PATENT LITIGATION | 2014-10-16 |
| Ferring B v. v. Watson Laboratories Inc. | 2014-04-17 |
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,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-[(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 |
| 61869-08-7 (Parent) |
| 78246-49-8 |
| AB0008509 |
| AB1004558 |
| AC1L1XYV |
| AK-49032 |
| AKOS015849162 |
| AKOS015907108 |
| AN-15600 |
| ANW-49202 |
| API0003757 |
| Aropax |
| Aropax 20 |
| AX8022605 |
| BG0380 |
| BR-49032 |
| BRL 29060 hydrochloride |
| BRL 29060A |
| BRL29060A |
| C19H20FNO3.HCl |
| C19H21ClFNO3 |
| CCG-39866 |
| CHEBI:7944 |
| CHEMBL1708 |
| CS-2611 |
| D05374 |
| DTXSID50228914 |
| EU-0100095 |
| GELRVIPPMNMYGS-RVXRQPKJSA-N |
| H29P351 |
| HMS1922B11 |
| HSDB 7175 |
| HY-B0492 |
| J10285 |
| KS-00000JOT |
| KS-5097 |
| LP00095 |
| LS-114251 |
| MFCD03658863 |
| MLS002222322 |
| MolPort-003-666-523 |
| 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 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)- |
| S-2491 |
| S3005 |
| SCHEMBL33348 |
| SDB 7175 |
| SMR001307264 |
| SPECTRUM1504085 |
| SR-01000759305 |
| SR-01000759305-6 |
| ST24025708 |
| SW197457-4 |
| TC-137947 |
| TL8005348 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 076618-003 | Aug 15, 2005 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Apotex Technologies | PAXIL | paroxetine hydrochloride | TABLET;ORAL | 020031-003 | Dec 29, 1992 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Sun Pharm Inds Inc | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET;ORAL | 078194-002 | Jun 29, 2007 | DISCN | 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 |
Expired US Patents for paroxetine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Apotex Technologies | PAXIL | paroxetine hydrochloride | SUSPENSION;ORAL | 020710-001 | Jun 25, 1997 | Start Trial | Start Trial |
| Apotex Technologies | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-004 | Oct 9, 1998 | Start Trial | Start Trial |
| Apotex Technologies | PAXIL | paroxetine hydrochloride | CAPSULE;ORAL | 020885-003 | Oct 9, 1998 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for paroxetine hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Indonesia | 27766 | Start Trial |
| Japan | 2002519421 | Start Trial |
| Denmark | 9900435 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.