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

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Last Updated: December 5, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020503

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NDA 020503 describes PROVENTIL-HFA, which is a drug marketed by 3m Drug Delivery and is included in one NDA. It is available from three suppliers. Additional details are available on the PROVENTIL-HFA profile page.

The generic ingredient in PROVENTIL-HFA is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
Summary for 020503
Tradename:PROVENTIL-HFA
Applicant:3m Drug Delivery
Ingredient:albuterol sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020503
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 020503
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROVENTIL-HFA albuterol sulfate AEROSOL, METERED;INHALATION 020503 NDA Merck Sharp & Dohme Corp. 0085-1132 0085-1132-04 1 CANISTER in 1 CARTON (0085-1132-04) > 200 AEROSOL, METERED in 1 CANISTER
PROVENTIL-HFA albuterol sulfate AEROSOL, METERED;INHALATION 020503 NDA AUTHORIZED GENERIC Par Pharmaceutical Inc. 0254-1007 0254-1007-52 1 CANISTER in 1 CARTON (0254-1007-52) > 200 AEROSOL, METERED in 1 CANISTER
Paragraph IV (Patent) Challenges for 020503
Tradename Dosage Ingredient NDA Submissiondate
PROVENTIL-HFA AEROSOL, METERED;INHALATION albuterol sulfate 020503 2015-05-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrengthEQ 0.09MG BASE/INH
Approval Date:Aug 15, 1996TE:BXRLD:Yes

Expired US Patents for NDA 020503

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
3m Drug Delivery PROVENTIL-HFA albuterol sulfate AEROSOL, METERED;INHALATION 020503-001 Aug 15, 1996   Start Trial   Start Trial
3m Drug Delivery PROVENTIL-HFA albuterol sulfate AEROSOL, METERED;INHALATION 020503-001 Aug 15, 1996   Start Trial   Start Trial
3m Drug Delivery PROVENTIL-HFA albuterol sulfate AEROSOL, METERED;INHALATION 020503-001 Aug 15, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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