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Last Updated: June 29, 2022

Nitric oxide - Generic Drug Details


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What are the generic sources for nitric oxide and what is the scope of patent protection?

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-five 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 forty-eight patent family members in fifteen countries.

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

Recent Clinical Trials for nitric oxide

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

SponsorPhase
The University of Texas Health Science Center, HoustonPhase 4
Josef StehlikPhase 4
Merck Sharp & Dohme LLCPhase 4

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
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
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
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
>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 020845-002 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
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 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
>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
Portugal 2968824 See Plans and Pricing
European Patent Office 2540304 Procédés pour réduire le risque ou prévenir l'apparition d'un événement défavorable ou d'un événement défavorable grave associés au traitement par oxyde nitrique inhalé (Methods for reducing the risk or preventing the occurrence of an adverse event or serious adverse event associated with the inhalation of nitric oxide treatment) See Plans and Pricing
European Patent Office 2131903 CONVERSION DU DIOXYDE D'AZOTE (NO2) EN OXYDE NITRIQUE (NO) (CONVERSION OF NITROGEN DIOXIDE (NO2) TO NITRIC OXIDE (NO)) See Plans and Pricing
China 110501462 用于补偿暴露于一氧化氮的电化学气体传感器的长期灵敏度漂移的方法 (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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