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. Fifty 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
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Patent Expiration: ⤷ Sign Up
Duloxetine sprinkles
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Patent Expiration: ⤷ Sign Up
Duloxetine sprinkles
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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 | |||
| >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 | 2005C/001 | Belgium | ⤷ Sign Up | PRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 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 | 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 |
| >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.
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