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Last Updated: January 27, 2023

Nitric oxide - Generic Drug Details


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What are the generic sources for nitric oxide and what is the scope of freedom to operate?

Nitric oxide is the generic ingredient in three branded drugs marketed by Vero Biotech, Mallinckrodt Hosp, and Linde Gas Equip, and is included in three NDAs. There are thirty-seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nitric oxide has one hundred and fifty-four patent family members in fifteen countries.

There are six drug master file entries for nitric oxide. Three suppliers are listed for this compound.

Recent Clinical Trials for nitric oxide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Simon Fraser UniversityPhase 2
Medical College of WisconsinEarly Phase 1
Massachusetts General HospitalEarly Phase 1

See all nitric oxide clinical trials

Pharmacology for nitric oxide
Drug Class Vasodilator
Physiological EffectVasodilation
Paragraph IV (Patent) Challenges for NITRIC OXIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
INOMAX for Inhalation nitric oxide 100 ppm and 800 ppm 020845 1 2014-05-20

US Patents and Regulatory Information for nitric oxide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Linde Gas Equip NOXIVENT nitric oxide GAS;INHALATION 207141-002 Oct 2, 2018 AA RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 AA RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Vero Biotech GENOSYL nitric oxide GAS;INHALATION 202860-001 Dec 20, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 AA RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for nitric oxide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 See Plans and Pricing See Plans and Pricing
Vero Biotech GENOSYL nitric oxide GAS;INHALATION 202860-001 Dec 20, 2019 See Plans and Pricing See Plans and Pricing
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999 See Plans and Pricing See Plans and Pricing
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999 See Plans and Pricing See Plans and Pricing
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for nitric oxide

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Linde Healthcare AB INOmax nitric oxide EMEA/H/C/000337
INOmax, in conjunction with ventilatory support and other appropriate active substances, is indicated:for the treatment of newborn infants ≥34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation;as part of the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation.
Authorised no no no 2001-08-01
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for nitric oxide

Country Patent Number Title Estimated Expiration
Japan 2022078116 二酸化窒素貯蔵カセット (NITROGEN DIOXIDE STORAGE CASSETTE) See Plans and Pricing
Denmark 3308820 See Plans and Pricing
Mexico 2014005524 APARATO Y METODO PARA VIGILAR EL SUMINISTRO DE OXIDO NITRICO. (APPARATUS AND METHOD FOR MONITORING NITRIC OXIDE DELIVERY.) See Plans and Pricing
Australia 2019253886 SYSTEMS AND METHODS FOR COMPENSATING LONG TERM SENSITIVITY DRIFT OF ELECTROCHEMICAL GAS SENSORS EXPOSED TO NITRIC OXIDE See Plans and Pricing
Canada 2939094 PROCEDES POUR COMPENSER UNE DERIVE DE SENSIBILITE A LONG TERME DE CAPTEURS DE GAZ ELECTROCHIMIQUES EXPOSES A DE L'OXYDE NITRIQUE (METHODS FOR COMPENSATING LONG TERM SENSITIVITY DRIFT OF ELECTROCHEMICAL GAS SENSORS EXPOSED TO NITRIC OXIDE) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for nitric oxide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0786264 SPC/GB08/019 United Kingdom See Plans and Pricing PRODUCT NAME: NITRIC OXIDE (NO); REGISTERED: UK EU/1/01/194/001 20010801
0560928 2002C/003 Belgium See Plans and Pricing PRODUCT NAME: NITRIC OXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
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Mallinckrodt

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