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Last Updated: January 21, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211367

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NDA 211367 describes SLYND, which is a drug marketed by Exeltis Usa Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the SLYND profile page.

The generic ingredient in SLYND is drospirenone. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the drospirenone profile page.
Summary for 211367
Tradename:SLYND
Applicant:Exeltis Usa Inc
Ingredient:drospirenone
Patents:2
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 211367
Generic Entry Date for 211367*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT
Dosage:
TABLET;ORAL

*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 NDA: 211367
Suppliers and Packaging for NDA: 211367
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SLYND drospirenone TABLET;ORAL 211367 NDA Exeltis USA, Inc. 0642-7470 0642-7470-02 1 BLISTER PACK in 1 CARTON (0642-7470-02) > 28 TABLET, FILM COATED in 1 BLISTER PACK (0642-7470-01)
SLYND drospirenone TABLET;ORAL 211367 NDA Exeltis USA, Inc. 0642-7470 0642-7470-03 3 BLISTER PACK in 1 CARTON (0642-7470-03) > 28 TABLET, FILM COATED in 1 BLISTER PACK (0642-7470-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:May 23, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:May 23, 2022
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  Start TrialPatent Expiration:Jun 28, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
Patent:  Start TrialPatent Expiration:Jun 28, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE

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