PALIPERIDONE PALMITATE Drug Patent Profile
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Which patents cover Paliperidone Palmitate, and when can generic versions of Paliperidone Palmitate launch?
Paliperidone Palmitate is a drug marketed by Teva Pharms Usa and is included in one NDA.
The generic ingredient in PALIPERIDONE PALMITATE is paliperidone palmitate. There are thirty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Paliperidone Palmitate
A generic version of PALIPERIDONE PALMITATE was approved as paliperidone palmitate by TEVA PHARMS USA on July 6th, 2021.
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Questions you can ask:
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Summary for PALIPERIDONE PALMITATE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 50 |
| Clinical Trials: | 58 |
| Patent Applications: | 133 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PALIPERIDONE PALMITATE |
| 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 |
| Luye Pharma Group Ltd. | Phase 1 |
Medical Subject Heading (MeSH) Categories for PALIPERIDONE PALMITATE
Anatomical Therapeutic Chemical (ATC) Classes 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 | 211149-001 | Jul 6, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa | PALIPERIDONE PALMITATE | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 211149-004 | Jul 6, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa | PALIPERIDONE PALMITATE | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 211149-002 | Jul 6, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa | PALIPERIDONE PALMITATE | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 211149-003 | Jul 6, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa | PALIPERIDONE PALMITATE | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 211149-005 | Jul 6, 2021 | AB | 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 |
