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

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Last Updated: November 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020845

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NDA 020845 describes INOMAX, which is a drug marketed by Mallinckrodt Hosp and is included in one NDA. It is available from one supplier. There are fifteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the INOMAX profile page.

The generic ingredient in INOMAX is nitric oxide. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nitric oxide profile page.
Summary for 020845
Tradename:INOMAX
Applicant:Mallinckrodt Hosp
Ingredient:nitric oxide
Patents:15
Formulation / Manufacturing:see details
Pharmacology for NDA: 020845
Physiological EffectVasodilation
Suppliers and Packaging for NDA: 020845
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INOMAX nitric oxide GAS;INHALATION 020845 NDA INO Therapeutics 64693-002 64693-002-01 1 CYLINDER in 1 CARTON (64693-002-01) > 353 L in 1 CYLINDER
INOMAX nitric oxide GAS;INHALATION 020845 NDA INO Therapeutics 64693-002 64693-002-02 1 CYLINDER in 1 CARTON (64693-002-02) > 1963 L in 1 CYLINDER
Paragraph IV (Patent) Challenges for 020845
Tradename Dosage Ingredient NDA Submissiondate
INOMAX GAS;INHALATION nitric oxide 020845 2014-05-20

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:GAS;INHALATIONStrength100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 23, 1999TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Dec 30, 2029Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Jul 6, 2031Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Dec 30, 2029Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 020845

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999   Start Trial   Start Trial
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999   Start Trial   Start Trial
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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