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Pimavanserin tartrate - Generic Drug Details
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What are the generic drug sources for pimavanserin tartrate and what is the scope of freedom to operate?
Pimavanserin tartrate
is the generic ingredient in one branded drug marketed by Acadia Pharms Inc and is included in two NDAs. There are nineteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Pimavanserin tartrate has one hundred and forty-seven patent family members in twenty-seven countries.
There are two drug master file entries for pimavanserin tartrate. One supplier is listed for this compound.
Summary for pimavanserin tartrate
| International Patents: | 147 |
| US Patents: | 19 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 23 |
| Clinical Trials: | 3 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for pimavanserin tartrate |
| DailyMed Link: | pimavanserin tartrate at DailyMed |
Recent Clinical Trials for pimavanserin tartrate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| ACADIA Pharmaceuticals Inc. | Phase 2 |
| ACADIA Pharmaceuticals Inc. | Phase 3 |
| ACADIA Pharmaceuticals Inc. | N/A |
Pharmacology for pimavanserin tartrate
| Drug Class | Atypical Antipsychotic |
Paragraph IV (Patent) Challenges for PIMAVANSERIN TARTRATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| NUPLAZID | TABLET;ORAL | pimavanserin tartrate | 207318 | 2020-04-29 |
| NUPLAZID | CAPSULE;ORAL | pimavanserin tartrate | 210793 | 2020-04-29 |
US Patents and Regulatory Information for pimavanserin tartrate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | CAPSULE;ORAL | 210793-001 | Jun 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | CAPSULE;ORAL | 210793-001 | Jun 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | TABLET;ORAL | 207318-002 | Jun 28, 2018 | RX | Yes | Yes | 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 pimavanserin tartrate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | CAPSULE;ORAL | 210793-001 | Jun 28, 2018 | Start Trial | Start Trial |
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | TABLET;ORAL | 207318-001 | Apr 29, 2016 | Start Trial | Start Trial |
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | TABLET;ORAL | 207318-001 | Apr 29, 2016 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for pimavanserin tartrate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1263729 | Start Trial |
| China | 102028949 | Start Trial |
| Japan | 2003531829 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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 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.
ISSN: 2162-2639
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