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DRIZALMA SPRINKLE Drug Profile
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» See Plans and PricingWhich patents cover Drizalma Sprinkle, and when can generic versions of Drizalma Sprinkle launch?
Drizalma Sprinkle is a drug marketed by Sun Pharma Global and is included in one NDA. There are two 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-four suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
US ANDA 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.
Summary for DRIZALMA SPRINKLE
| International Patents: | 1 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | DRIZALMA SPRINKLE at DailyMed |
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharma Global | DRIZALMA SPRINKLE | duloxetine hydrochloride | CAPSULE, DELAYED RELEASE;ORAL | 212516-001 | Jul 19, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Sun Pharma Global | DRIZALMA SPRINKLE | duloxetine hydrochloride | CAPSULE, DELAYED RELEASE;ORAL | 212516-004 | Jul 19, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sun Pharma Global | DRIZALMA SPRINKLE | duloxetine hydrochloride | CAPSULE, DELAYED RELEASE;ORAL | 212516-002 | Jul 19, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Sun Pharma Global | DRIZALMA SPRINKLE | duloxetine hydrochloride | CAPSULE, DELAYED RELEASE;ORAL | 212516-004 | Jul 19, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sun Pharma Global | DRIZALMA SPRINKLE | duloxetine hydrochloride | CAPSULE, DELAYED RELEASE;ORAL | 212516-001 | Jul 19, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Sun Pharma Global | DRIZALMA SPRINKLE | duloxetine hydrochloride | CAPSULE, DELAYED RELEASE;ORAL | 212516-002 | Jul 19, 2019 | RX | Yes | No | Start Trial | Start Trial | 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 |
International Patents for DRIZALMA SPRINKLE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 3335697 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for DRIZALMA SPRINKLE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0273658 | C300171 | Netherlands | Start Trial | 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 | Start Trial | PRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 20040811 |
| 0273658 | SPC/GB05/003 | United Kingdom | Start Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
