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Last Updated: December 14, 2019

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NUPLAZID Drug Profile

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Which patents cover Nuplazid, and when can generic versions of Nuplazid launch?

Nuplazid is a drug marketed by Acadia Pharms Inc and is included in two NDAs. There are fifteen patents protecting this drug.

This drug has one hundred and forty-four patent family members in twenty-seven countries.

The generic ingredient in NUPLAZID is pimavanserin tartrate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pimavanserin tartrate profile page.

US ANDA Litigation and Generic Entry Outlook for Nuplazid

Nuplazid will be eligible for patent challenges on April 29th, 2020. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 3rd, 2028. This may change due to patent challenges or generic licensing.

Summary for NUPLAZID
International Patents:144
US Patents:15
Applicants:1
NDAs:2
Suppliers / Packagers: 1
Bulk Api Vendors: 23
Clinical Trials: 1
Drug Prices: Drug price information for NUPLAZID
DailyMed Link:NUPLAZID at DailyMed
Drug patent expirations by year for NUPLAZID
Drug Prices for NUPLAZID

See drug prices for NUPLAZID

Generic Entry Opportunity Date for NUPLAZID
Generic Entry Dates for NUPLAZID*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for NUPLAZID*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for NUPLAZID

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

SponsorPhase
University Hospital, Strasbourg, FrancePhase 2

See all NUPLAZID clinical trials

Pharmacology for NUPLAZID
Synonyms for NUPLAZID
1-(4-fluorobenzyl)-3-(4-isobutoxybenzyl)-1-(1-methylpiperidin-4-yl)urea (2R,3R)-2,3-dihydroxysuccinate
706782-28-7
868855-07-6
AC-29901
ACP 103
ACP-103
AKOS027327334
Bis(1-(4-Fluorobenzyl)-1-(1-methylpiperidin-4-yl)-3-(4-(2-methylpropoxy)benzyl)urea) (2R,3R)-2,3-dihydroxybutanedioate
bis(4-{[(4-fluorophenyl)methyl]({[4-(2-methylpropoxy)phenyl]methyl}carbamoyl)amino}-1-methylpiperidin-1-ium) (2R,3R)-2,3-dihydroxybutanedioate
bis{N-[(4-fluorophenyl)methyl]-N-(1-methylpiperidin-4-yl)-N'-{[4-(2-methylpropoxy)phenyl]methyl}urea} (2R,3R)-2,3-dihydroxybutanedioate
CHEBI:133014
CS-7954
D08969
DTXSID50220958
HY-14557A
LS-193533
MolPort-006-170-072
N-(4-Fluorophenylmethyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phenylmethyl) carbamide (2R,3R)-dihydroxybutanedioate (2:1)
N-(4-Fluorophenylmethyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phenylmethyl)carbamide
NA83F1SJSR
Nuplazide (TN)
Pimavanserin Dihydroxysuccinate(2:1)
pimavanserin hemitartrate
Pimavanserin tartrate
Pimavanserin tartrate (USAN)
Pimavanserin tartrate [USAN]
SC-90507
UNII-NA83F1SJSR
Urea, N-((4-fluorophenyl)methyl)-N-(1-methyl-4-piperidinyl)-N'-((4-(2-methylpropoxy)phenyl)methyl)-, (2R,3R)-2,3-dihydroxybutanedioate (2:1)

US Patents and Regulatory Information for NUPLAZID

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 TABLET;ORAL 207318-001 Apr 29, 2016 DISCN Yes No   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
Acadia Pharms Inc NUPLAZID pimavanserin tartrate TABLET;ORAL 207318-001 Apr 29, 2016 DISCN Yes No   Start Trial   Start Trial   Start Trial
Acadia Pharms Inc NUPLAZID pimavanserin tartrate TABLET;ORAL 207318-002 Jun 28, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Acadia Pharms Inc NUPLAZID pimavanserin tartrate TABLET;ORAL 207318-001 Apr 29, 2016 DISCN Yes No   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
Acadia Pharms Inc NUPLAZID pimavanserin tartrate CAPSULE;ORAL 210793-001 Jun 28, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
Dow

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