Paliperidone palmitate - Generic Drug Details
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What are the generic drug sources for paliperidone palmitate and what is the scope of patent protection?
Paliperidone palmitate
is the generic ingredient in four branded drugs marketed by Janssen Pharms and Teva Pharms Usa, and is included in three NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Paliperidone palmitate has one hundred and seven patent family members in thirty-one countries.
There are twelve drug master file entries for paliperidone palmitate. Two suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for paliperidone palmitate
| International Patents: | 107 |
| US Patents: | 5 |
| Tradenames: | 4 |
| Applicants: | 2 |
| NDAs: | 3 |
| Drug Master File Entries: | 12 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 50 |
| Clinical Trials: | 58 |
| Patent Applications: | 360 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for paliperidone palmitate |
| What excipients (inactive ingredients) are in paliperidone palmitate? | paliperidone palmitate excipients list |
| DailyMed Link: | paliperidone palmitate at DailyMed |
Recent Clinical Trials for paliperidone palmitate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| First Affiliated Hospital Xi'an Jiaotong University | N/A |
| Janssen-Cilag International NV | Phase 4 |
| Alliance for Clinical Trials in Oncology | Phase 1 |
Generic filers with tentative approvals for PALIPERIDONE PALMITATE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try a Trial | ⤷ Try a Trial | SUSPENSION;EXTENDED RELEASE | |
| ⤷ Try a Trial | ⤷ Try a Trial | 156MG/ML | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
| ⤷ Try a Trial | ⤷ Try a Trial | 117MG/0.75ML | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
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 paliperidone palmitate
| Drug Class | Atypical Antipsychotic |
Medical Subject Heading (MeSH) Categories for paliperidone palmitate
Paragraph IV (Patent) Challenges for PALIPERIDONE PALMITATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| INVEGA TRINZA | Extended-release Injectable Suspension | paliperidone palmitate | 273 mg/0.875 mL and 410 mg/1.315 mL | 207946 | 1 | 2021-07-14 |
| INVEGA TRINZA | Extended-release Injectable Suspension | paliperidone palmitate | 819 mg/2.625 mL | 207946 | 1 | 2021-04-30 |
| INVEGA TRINZA | Extended-release Injectable Suspension | paliperidone palmitate | 546 mg/1.75 mL | 207946 | 1 | 2020-06-24 |
| INVEGA SUSTENNA | Extended-release Injectable Suspension | paliperidone palmitate | 39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL and 234 mg/1.5 mL | 022264 | 1 | 2017-11-21 |
US Patents and Regulatory Information for paliperidone palmitate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Pharms Usa | PALIPERIDONE PALMITATE | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 211149-002 | Jul 6, 2021 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-002 | May 18, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Janssen Pharms | INVEGA HAFYERA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-006 | Aug 30, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 paliperidone palmitate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-001 | Jul 31, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-004 | Jul 31, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-001 | Jul 31, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for paliperidone palmitate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Portugal | 2234617 | ⤷ Try a Trial | |
| Denmark | 3280416 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2022111859 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for paliperidone palmitate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0904081 | 2011/021 | Ireland | ⤷ Try a Trial | PRODUCT NAME: PALIPERIDONE PALMITATE ESTER; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304 |
| 0368388 | 07C0044 | France | ⤷ Try a Trial | PRODUCT NAME: PALIPERIDONE; REGISTRATION NO/DATE IN FRANCE: EU/1/07/395/01 DU 20070626; REGISTRATION NO/DATE AT EEC: EU/1/07/395/01 DU 20070625 |
| 0904081 | 11C0035 | France | ⤷ Try a Trial | PRODUCT NAME: PALMITATE DE PALIPERIDONE; REGISTRATION NO/DATE: EU/1/11/672/001 20110304 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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 verification 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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