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 |
Recent Clinical Trials for DRIZALMA SPRINKLE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Scripps Health | Phase 2 |
Pharmacology for DRIZALMA SPRINKLE
Drug Class | Serotonin and Norepinephrine Reuptake Inhibitor |
Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
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 |