Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Citi
Accenture
Chinese Patent Office
Fuji
Cerilliant
Teva
Daiichi Sankyo
Moodys
Mallinckrodt

Generated: July 19, 2018

DrugPatentWatch Database Preview

INVEGA SUSTENNA Drug Profile

see a sample report or, see our see our flat-rate plans

« Back to Dashboard

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

Invega Sustenna is a drug marketed by Janssen Pharms and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-six patent family members in thirty-seven countries.

The generic ingredient in INVEGA SUSTENNA is paliperidone palmitate. There are thirty-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.
Drug patent expirations by year for INVEGA SUSTENNA
Generic Entry Opportunity Date for INVEGA SUSTENNA
Generic Entry Date for INVEGA SUSTENNA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

*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.

Pharmacology for INVEGA SUSTENNA
Medical Subject Heading (MeSH) Categories for INVEGA SUSTENNA
Synonyms for INVEGA SUSTENNA
(9R)-3-[2-[4-(6-Fluoro-1,2-benzoisoxazole-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-9-(palmitoyloxy)-4H-pyrido[1,2-a]pyrimidine-4-one
(9R)-3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-2-methyl-4-oxo-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-9-yl hexadecanoate
(9RS)-3-(2-(4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl)ethyl)-2-methyl-4-oxo-6,7,8,9-tetrahydro-4H-pyrido(1,2-a)pyrimidin-9-yl hexadecanoate
(R)-paliperidone hexadecanoate
(R)-paliperidone palmitate
199739-10-1
3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-2-methyl-4-oxo-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-9-yl hexadecanoate
3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-2-methyl-4-oxo-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-9-yl hexadecanoate
44W02N396B
9-Hydroxyrisperidone Palmitate
AKOS030526057
CHEBI:83808
CHEBI:83810
CHEMBL2107360
D05340
FT-0673476
Hexadecanoic Acid 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4-oxo-4H-pyrido[1,2-a]pyrimidin-9-yl Ester
Hexadecanoic acid, 3-(2-(4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-6,7,8,9-tetrahydro-2-methyl-4-oxo-4H-pyrido(1,2-a)pyrimidin-9-yl ester
JNS 010
LP017660
LP079731
MolPort-044-559-897
Paliperidone Palmitate
Paliperidone palmitate (JAN/USAN)
Paliperidone Palmitate [USAN]
PALPERIDONE PALMITATE
R8P8USM8FR
Ro 92670
RO92670
SC-84561
SCHEMBL12415674
SCHEMBL18131955
SCHEMBL1871384
Trevicta (TN)
Trinza
UNII-44W02N396B
UNII-R8P8USM8FR
Xeplion (TN)
ZINC68151119

US Patents and Regulatory Information for INVEGA SUSTENNA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-001 Jul 31, 2009 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-002 Jul 31, 2009 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-001 Jul 31, 2009 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-003 Jul 31, 2009 RX 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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

see a sample report or, see our see our flat-rate plans

Expired US Patents for INVEGA SUSTENNA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-005 Jul 31, 2009 ➤ Sign Up ➤ Sign Up
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-004 Jul 31, 2009 ➤ Sign Up ➤ Sign Up
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-005 Jul 31, 2009 ➤ Sign Up ➤ Sign Up
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-001 Jul 31, 2009 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Paragraph IV (Patent) Challenges for INVEGA SUSTENNA
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Injectable Suspension 39 mg/0.25 mL,78 mg/0.5 mL,117 mg/0.75 mL,156 mg/mL and234 mg/1.5 mL ➤ Subscribe ➤ Sign Up

Non-Orange Book US Patents for INVEGA SUSTENNA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,320,707 Aqueous suspensions of submicron 9-hydroxyrisperidone fatty acid esters ➤ Sign Up
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

see a sample report or, see our see our flat-rate plans

Supplementary Protection Certificates for INVEGA SUSTENNA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB11/044 United Kingdom ➤ Sign Up PRODUCT NAME: PALIPERIDONE PALMITATE; REGISTERED: UK EU/1/11/672/001 20110304; UK EU/1/11/672/002 20110304; UK EU/1/11/672/003 20110304; UK EU/1/11/672/004 20110304; UK EU/1/11/672/005 20110304; UK EU/1/11/672/006 20110304
C/GB07/065 United Kingdom ➤ Sign Up PRODUCT NAME: PALIPERIDONE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/07/395/001 20070625; UK EU/1/07/395/002 20070625; UK EU/1/07/395/003 20070625; UK EU/1/07/395/004 20070625; UK EU/1/07/395/005 20070625; UK EU/1/07/395/006 20070625; UK EU/1/07/395/007 20070625; UK EU/1/07/395/008 20070625; UK EU/1/07/395/009 20070625; UK EU/1/07/395/010 20070625; UK EU/1/07/395/011 20070625; UK EU/1/07/395/012 20070625; UK EU/1/07/395/013 20070625; UK EU/1/07/395/014 20070625; UK EU/1/07/395/015 20070625; UK EU/1/07/395/016 20070625; UK EU/1/07/395/017 20070625; UK EU/1/07/395/018 20070625; UK EU/1/07/395/019 20070625; UK EU/1/07/395/020 20070625; UK EU/1/07/395/021
C0035 France ➤ Sign Up PRODUCT NAME: PALMITATE DE PALIPERIDONE; REGISTRATION NO/DATE: EU/1/11/672/001 20110304
11/021 Ireland ➤ Sign Up PRODUCT NAME: PALIPERIDONE PALMITATE ESTER; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Express Scripts
Chinese Patent Office
Merck
Queensland Health
Dow
Deloitte
Medtronic
Federal Trade Commission

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 verifification 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.