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Last Updated: November 4, 2024

DRIZALMA SPRINKLE Drug Patent Profile


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

Drizalma Sprinkle is a drug marketed by Sun Pharm and is included in one NDA. There are four patents protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in DRIZALMA SPRINKLE is duloxetine hydrochloride. There are forty-two drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Drizalma Sprinkle

A generic version of DRIZALMA SPRINKLE was approved as duloxetine hydrochloride by AUROBINDO PHARMA LTD on December 11th, 2013.

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Summary for DRIZALMA SPRINKLE
International Patents:1
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 202
Clinical Trials: 1
Patent Applications: 4,320
What excipients (inactive ingredients) are in DRIZALMA SPRINKLE?DRIZALMA SPRINKLE excipients list
DailyMed Link:DRIZALMA SPRINKLE at DailyMed
Drug patent expirations by year for DRIZALMA SPRINKLE
Recent Clinical Trials for DRIZALMA SPRINKLE

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

SponsorPhase
Scripps HealthPhase 2

See all DRIZALMA SPRINKLE clinical trials

US Patents and Regulatory Information for DRIZALMA SPRINKLE

DRIZALMA SPRINKLE is protected by four US patents.

Patents protecting DRIZALMA SPRINKLE

Duloxetine sprinkles
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Duloxetine sprinkles
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Duloxetine sprinkles
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Duloxetine sprinkles
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm DRIZALMA SPRINKLE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212516-001 Jul 19, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sun Pharm DRIZALMA SPRINKLE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212516-002 Jul 19, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sun Pharm DRIZALMA SPRINKLE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212516-001 Jul 19, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sun Pharm DRIZALMA SPRINKLE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212516-003 Jul 19, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sun Pharm DRIZALMA SPRINKLE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212516-002 Jul 19, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for DRIZALMA SPRINKLE

See the table below for patents covering DRIZALMA SPRINKLE around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 3335697 ÉCLATS DE DULOXÉTINE (DULOXETINE SPRINKLES) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DRIZALMA SPRINKLE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0273658 SPC/GB05/003 United Kingdom ⤷  Sign Up PRODUCT NAME: DULOXETINE AND PHARMACUETICALLY ACCEPTABLE ACID ADDITION SALTS THEREOF, AND IN PARTICULAR DULOXETINE HYDROCHLORIDE; REGISTERED: UK EU/1/04/280/001 20040811; UK EU/1/04/280/002 20040811; UK EU/1/04/280/003 20040811; UK EU/1/04/280/004 20040811; UK EU/1/04/280/005 20040811; UK EU/1/04/280/006 20040811
0273658 C300171 Netherlands ⤷  Sign Up PRODUCT NAME: DULOXETINE EN FARMACEUTISCH AANVAARDBARE ZUURADDITIEZOUTEN DAARVAN, EN IN HET BIJZONDER DULOXETINE HYDROCHLORIDE; NATL REGISTRATION NO/DATE: EU/1/04/280/001-006 20040811
0273658 2005C/001 Belgium ⤷  Sign Up PRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 20040811
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.