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Last Updated: June 23, 2024

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 two branded drugs marketed by Acadia Pharms Inc, MSN, and Zydus, and is included in five NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pimavanserin tartrate has eighty-eight patent family members in twenty-two countries.

There are two drug master file entries for pimavanserin tartrate. One supplier is listed for this compound.

Summary for PIMAVANSERIN TARTRATE
Recent Clinical Trials for PIMAVANSERIN TARTRATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
ACADIA Pharmaceuticals Inc.Phase 2
ACADIA Pharmaceuticals Inc.Phase 3
ACADIA Pharmaceuticals Inc.

See all PIMAVANSERIN TARTRATE clinical trials

Pharmacology for PIMAVANSERIN TARTRATE
Paragraph IV (Patent) Challenges for PIMAVANSERIN TARTRATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NUPLAZID Tablets pimavanserin tartrate 10 mg 207318 1 2020-04-29
NUPLAZID Capsules pimavanserin tartrate 34 mg 210793 5 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 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Acadia Pharms Inc NUPLAZID pimavanserin tartrate CAPSULE;ORAL 210793-001 Jun 28, 2018 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Acadia Pharms Inc NUPLAZID pimavanserin tartrate TABLET;ORAL 207318-001 Apr 29, 2016 DISCN Yes 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 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 ⤷  Sign Up ⤷  Sign Up
Acadia Pharms Inc NUPLAZID pimavanserin tartrate TABLET;ORAL 207318-002 Jun 28, 2018 ⤷  Sign Up ⤷  Sign Up
Acadia Pharms Inc NUPLAZID pimavanserin tartrate TABLET;ORAL 207318-001 Apr 29, 2016 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for PIMAVANSERIN TARTRATE

Country Patent Number Title Estimated Expiration
Singapore 161221 SYNTHESIS OF N-(4-FLUOROBENZYL)-N-(1-METHYLPIPERIDIN-4-YL)-NÆ-(4-(2- METHYLPROPYLOXY)PHENYLMETHYL)CARBAMIDE AND ITS TARTRATE SALT AND CRYSTALLINE FORMS ⤷  Sign Up
Mexico 2007003433 SINTESIS DE N-FLUOROBENCIL) -N- (1-METILPIPERIDIN-4-IL) -N'- (4- (2-METILPROPILOXI) FENILMETIL) CARBAMIDA Y SU SAL DE TARTRATO Y FORMAS CRISTALINAS. (SYNTHESIS OF N-(4-FLUOROBENZYL)-N-(1-METHYLPIPERIDIN-4-YL)-N'-(4- (2-METHYLPROPYLOXY)PHENYLMETHYL)CARBAMIDE AND ITS TARTRATE SALT AND CRYSTALLINE FORMS.) ⤷  Sign Up
European Patent Office 2289879 Synthèse d'une forme cristalline du sel de tartrate de n-(4-fluorobenzyl)-n-(1-methylpiperidin-4-yl)-n'-(4-(2-methylpropyloxy)phenylmethyl)carbamide (Synthesis of a crystalline form of n-(4-fluorobenzyl)-n-(1-methylpiperidin-4-yl)-n'-(4-(2-methylpropyloxy)phenylmethyl)carbamide tartrate salt) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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