Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208799

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NDA 208799 describes AIRDUO RESPICLICK, which is a drug marketed by Teva Pharm and is included in one NDA. It is available from three suppliers. There are nineteen patents protecting this drug. Additional details are available on the AIRDUO RESPICLICK profile page.

The generic ingredient in AIRDUO RESPICLICK is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.
Summary for 208799
Pharmacology for NDA: 208799
Suppliers and Packaging for NDA: 208799
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-3607 0093-3607-82 1 POUCH in 1 CARTON (0093-3607-82) > 1 INHALER in 1 POUCH > 60 POWDER, METERED in 1 INHALER
AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-3607 0093-3607-82 1 POUCH in 1 CARTON (0093-3607-82) > 1 INHALER in 1 POUCH > 60 POWDER, METERED in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength0.055MG/INH;EQ 0.014MG BASE/INH
Approval Date:Jan 27, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 27, 2020
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  See PricingPatent Expiration:May 18, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:  See PricingPatent Expiration:May 18, 2031Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 208799

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-001 Jan 27, 2017   See Pricing   See Pricing
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-003 Jan 27, 2017   See Pricing   See Pricing
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-002 Jan 27, 2017   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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