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Palonosetron hydrochloride - Generic Drug Details
What are the generic sources for palonosetron hydrochloride and what is the scope of palonosetron hydrochloride patent protection?
Palonosetron hydrochloride
is the generic ingredient in two branded drugs marketed by Helsinn Hlthcare, Cipla Ltd, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Hospira Inc, Mylan Institutional, Qilu Pharm Co Ltd, Sagent Pharms, Sandoz Inc, Teva Pharms Usa, Virtus Pharm, and Exela Pharma Science, and is included in seventeen NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are twenty-one drug master file entries for palonosetron hydrochloride. Sixteen suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for palonosetron hydrochloride
| US Patents: | 13 |
| Tradenames: | 2 |
| Applicants: | 12 |
| NDAs: | 17 |
| Drug Master File Entries: | 21 |
| Suppliers / Packagers: | 16 |
| Bulk Api Vendors: | 66 |
| Clinical Trials: | 90 |
| Patent Applications: | 416 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for palonosetron hydrochloride |
| DailyMed Link: | palonosetron hydrochloride at DailyMed |
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-[(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 |
| 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 |
| MFCD00939524 |
| MLS001424202 |
| MolPort-005-932-622 |
| MolPort-016-638-380 |
| NC00331 |
| NCGC00166415-01 |
| NCGC00166415-03 |
| NSC-743769 |
| NSC743769 |
| OLDRWYVIKMSFFB-SSPJITILSA-N |
| Onicit |
| Onicita |
| 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-25259-197 |
| RTC-070923 |
| s3050 |
| SAM001246791 |
| SCHEMBL182478 |
| SMR000469233 |
| ST51052757 |
| TC-070923 |
| Tox21_112421 |
| Tox21_112421_1 |
| UNII-1J5X5HPB4C |
| UNII-23310D4I19 |
| W-5346 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Exela Pharma Science | PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | SOLUTION;INTRAVENOUS | 207963-001 | Aug 22, 2016 | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-001 | Jul 25, 2003 | AP | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Sandoz Inc | PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 202521-001 | Oct 13, 2015 | AP | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-002 | Feb 29, 2008 | AP | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Dr Reddys Labs Ltd | PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 201533-001 | Apr 21, 2016 | AP | RX | 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 |
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 | ➤ Sign Up | ➤ Sign Up |
| Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-001 | Jul 25, 2003 | ➤ Sign Up | ➤ Sign Up |
| Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-002 | Feb 29, 2008 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for palonosetron hydrochloride
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Morocco | 27710 | ➤ Sign Up |
| New Zealand | 541533 | ➤ Sign Up |
| Panama | 8594801 | ➤ Sign Up |
| Tunisia | SN05180 | ➤ Sign Up |
| Canada | 2573241 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for palonosetron hydrochloride
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 745 | Luxembourg | ➤ Sign Up | PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527 |
| /2005 | Austria | ➤ Sign Up | PRODUCT NAME: PALONOSETRON, DESSEN SALZE UND STEREOISOMERE; REGISTRATION NO/DATE: EU/1/04/306/001 20050322 |
| C/GB05/032 | United Kingdom | ➤ Sign Up | PRODUCT NAME: PALONOSETRON OR AN ISOMER, MIXTURE OF ISOMERS, N-OXIDE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/306/001 20050322 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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