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Palonosetron hydrochloride - Generic Drug Details
What are the generic sources for palonosetron hydrochloride and what is the scope of patent protection?
Palonosetron hydrochloride
is the generic ingredient in two branded drugs marketed by Helsinn Hlthcare, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Hospira Inc, Mylan Institutional, Qilu Pharm Co Ltd, Sagent Pharms Inc, Sandoz Inc, Teva Pharms Usa, Virtus Pharm, and Hikma, and is included in eighteen NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Palonosetron hydrochloride has fifty-three patent family members in forty countries.
There are twenty-one drug master file entries for palonosetron hydrochloride. Seventeen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for palonosetron hydrochloride
| International Patents: | 53 |
| US Patents: | 13 |
| Tradenames: | 2 |
| Applicants: | 13 |
| NDAs: | 18 |
| Drug Master File Entries: | 21 |
| Suppliers / Packagers: | 17 |
| Bulk Api Vendors: | 74 |
| Clinical Trials: | 97 |
| Patent Applications: | 514 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for palonosetron hydrochloride |
| DailyMed Link: | palonosetron hydrochloride at DailyMed |
Recent Clinical Trials for palonosetron hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Heron Therapeutics | Phase 2 |
| University of Alabama at Birmingham | Phase 2 |
| Memorial Sloan Kettering Cancer Center | N/A |
Recent Litigation for palonosetron hydrochloride
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Helsinn Healthcare S.A. v. Baxter Healthcare Corporation | 2018-10-25 |
| HELSINN HEALTHCARE S.A. v. ACTAVIS LLC | 2016-03-24 |
| HELSINN HEALTHCARE S.A. v. SAGENT PHARMACEUTICALS, INC. | 2016-01-11 |
See all palonosetron hydrochloride litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Dr. Reddy's Laboratories, Ltd | 2016-02-05 |
| Dr. Reddy's Laboratories, Ltd | 2015-07-03 |
| Dr. Reddy's Laboratories, Ltd. | 2015-07-03 |
Generic filers with tentative approvals for PALONOSETRON HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 0.25MG(BASE)/5ML | INJECTABLE;INJECTION |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for palonosetron hydrochloride
| Drug Class | Serotonin-3 Receptor Antagonist |
| Mechanism of Action | Serotonin 3 Receptor Antagonists |
Synonyms for palonosetron hydrochloride
| (2R,3R,6R)-2-methyl-6-(phenylsulfanyl)-3,6-dihydro-2H-pyran-3-ol |
| (3aS)-2-((3S)-quinuclidin-3-yl)-2,3,3a,4,5,6-hexahydro-1H-benzo[de]isoquinolin-1-one hydrochloride |
| (3aS)-2-(3S)-1-Azabicyclo[2.2.2]oct-3-yl-2,3,3a,4,5,6-hexahydro-1H-benz[de]isoquinolin-1-one Hydrochloride |
| (3aS)-2-(3S)-1-Azabicyclo[2.2.2]oct-3-yl-2,3,3a,4,5,6-hexahydro-1H-benz[de]isoquinolin-1-one monohydrochloride |
| (3aS)-2-[(3S)-1-azabicyclo[2.2.2]octan-3-yl]-2,3,3a,4,5,6-hexahydro-1H-benzo[de]isoquinolin-1-one--hydrogen chloride (1/1) |
| (3aS)-2-[(3S)-1-azabicyclo[2.2.2]octan-3-yl]-3a,4,5,6-tetrahydro-3H-benzo[de]isoquinolin-1-one hydrochloride |
| (3aS)-2-[(3S)-1-azabicyclo[2.2.2]octan-3-yl]-3a,4,5,6-tetrahydro-3H-benzo[de]isoquinolin-1-one;hydrochloride. |
| (3as)-2-[(s)-1-azabicyclo[2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1h-benz[de]isoquinoline hydrochloride |
| (3aS)-2,3,3a,4,5,6-Hexahydro-2-((3S)-3-quinuclidinyl)-1H-benz(de)isoquinolin-1-one monohydrochloride |
| (3S)-3-[(3aS)-1-oxo-3a,4,5,6-tetrahydro-1H-benzo[de]isoquinolin-2(3H)-yl]-1-azabicyclo[2.2.2]octan-1-ium chloride |
| (R,S)-Palonosetron HCl |
| (S,R)-Palonosetron HCl |
| (S,S)-Palonosetron Hydrochloride |
| (S)-2-((S)-quinuclidin-3-yl)-2,3,3a,4,5,6-hexahydro-1H-benzo[de]isoquinolin-1-one hydrochloride |
| 1021481-16-2 |
| 135729-62-3 |
| 135729-76-9 |
| 1H-Benz(de)isoquinolin-1-one, 2-(3S)-1-azabicyclo(2.2.2)oct-3-yl-2,3,3a,4,5,6-hexahydro-, monohydrochloride, (3aS)- |
| 1H-Benz[de]isoquinolin-1-one,3,3a,4,5,6-hexahydro-, (3aS)- hydrochloride |
| 1H-Benz[de]isoquinolin-1-one,3,3a,4,5,6-hexahydro-, [S-(R*,R*)]-, hydrochloride |
| 1J5X5HPB4C |
| 23310D4I19 |
| 729P623 |
| A806977 |
| AB0105782 |
| AC-1293 |
| AC1OCF9K |
| ACN-040771 |
| AK162860 |
| AKOS015895112 |
| AKOS026751493 |
| Aloxi |
| Aloxi (TN) |
| API0003734 |
| BC201360 |
| C-20102 |
| CAS-135729-62-3 |
| CC-33456 |
| CCG-101081 |
| CCG-221268 |
| CHEBI:85157 |
| CHEMBL1720 |
| CPD000469233 |
| CS-0621 |
| CTK8F0325 |
| D05343 |
| DSSTox_CID_26610 |
| DSSTox_GSID_46610 |
| DSSTox_RID_81765 |
| DTXSID8046610 |
| EN300-221649 |
| FT-0600824 |
| HY-A0021 |
| I14-20251 |
| KS-00000SN1 |
| MLS001424202 |
| MolPort-005-932-622 |
| MolPort-016-638-380 |
| NC00331 |
| NCGC00166415-01 |
| NCGC00166415-03 |
| NSC-743769 |
| NSC743769 |
| OLDRWYVIKMSFFB-SSPJITILSA-N |
| Onicit |
| Onicita |
| P-225 |
| P2051 |
| Palonosetron (Hydrochloride) |
| PALONOSETRON HCl |
| Palonosetron hydrochloride (Aloxi) |
| Palonosetron hydrochloride (JAN/USAN) |
| Palonosetron hydrochloride [USAN:JAN] |
| Palonosetron hydrochloride, (3R)- |
| Palonosetron hydrochloride, >=98% (HPLC) |
| Palonosetron hydrochloride, United States Pharmacopeia (USP) Reference Standard |
| Palonosetronhydrochloride hydrochloride |
| Paloxi |
| RL01606 |
| RS 25233-197 |
| RS 25259-197 |
| RS-25259-197 |
| RTC-070923 |
| s3050 |
| SAM001246791 |
| SCHEMBL182478 |
| SMR000469233 |
| TC-070923 |
| Tox21_112421 |
| Tox21_112421_1 |
| UNII-1J5X5HPB4C |
| UNII-23310D4I19 |
| W-5346 |
Paragraph IV (Patent) Challenges for PALONOSETRON HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ALOXI | INJECTABLE;INTRAVENOUS | palonosetron hydrochloride | 021372 | 2011-05-27 |
US Patents and Regulatory Information for palonosetron hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-002 | Feb 29, 2008 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Qilu Pharm Co Ltd | PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 205648-002 | Sep 19, 2018 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mylan Institutional | PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 206416-001 | Sep 19, 2018 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-001 | Jul 25, 2003 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 palonosetron hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | CAPSULE;ORAL | 022233-001 | Aug 22, 2008 | Start Trial | Start Trial |
| Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-001 | Jul 25, 2003 | Start Trial | Start Trial |
| Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-002 | Feb 29, 2008 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for palonosetron hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Norway | 329500 | Start Trial |
| Poland | 378398 | Start Trial |
| Malaysia | 144036 | Start Trial |
| Croatia | P20050676 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for palonosetron hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0430190 | SPC/GB05/032 | United Kingdom | Start Trial | PRODUCT NAME: PALONOSETRON OR AN ISOMER, MIXTURE OF ISOMERS, N-OXIDE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/306/001 20050322 |
| 1035115 | 92745 | Luxembourg | Start Trial | PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527 |
| 0430190 | 18/2005 | Austria | Start Trial | PRODUCT NAME: PALONOSETRON, DESSEN SALZE UND STEREOISOMERE; REGISTRATION NO/DATE: EU/1/04/306/001 20050322 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2019 - 2020
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.