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Last Updated: March 28, 2024

Nitric oxide - Generic Drug Details


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

Nitric oxide is the generic ingredient in four branded drugs marketed by Vero Biotech Inc, Mallinckrodt Hosp, Linde Gas Equip, and Airgas Therap, and is included in four NDAs. There are thirty-nine 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 seventy-one patent family members in fifteen countries.

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

Recent Clinical Trials for nitric oxide

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

SponsorPhase
Ain Shams UniversityPhase 3
University of Alabama at BirminghamEarly Phase 1
Wake Forest University Health SciencesPhase 1

See all nitric oxide clinical trials

Pharmacology for nitric oxide
Drug ClassVasodilator
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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Airgas Therap ULSPIRA nitric oxide GAS;INHALATION 203144-001 Jul 27, 2023 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Vero Biotech Inc GENOSYL nitric oxide GAS;INHALATION 202860-001 Dec 20, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Vero Biotech Inc GENOSYL nitric oxide GAS;INHALATION 202860-001 Dec 20, 2019 ⤷  Try a Trial ⤷  Try a Trial
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999 ⤷  Try a Trial ⤷  Try a Trial
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999 ⤷  Try a Trial ⤷  Try a Trial
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 ⤷  Try a Trial ⤷  Try a Trial
>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
Australia 2012335937 Apparatus and method for monitoring nitric oxide delivery ⤷  Try a Trial
Japan 7029497 ⤷  Try a Trial
Australia 2017202301 Methods of treating patients having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension ⤷  Try a Trial
Hong Kong 1220415 用於監測氧化氮輸送的器械和方法 (APPARATUS AND METHOD FOR MONITORING NITRIC OXIDE DELIVERY) ⤷  Try a Trial
Canada 2905644 APPAREIL ET PROCEDE POUR LA SURVEILLANCE DE L'ADMINISTRATION D'OXYDE NITRIQUE (APPARATUS AND METHOD FOR MONITORING NITRIC OXIDE DELIVERY) ⤷  Try a Trial
>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 ⤷  Try a Trial PRODUCT NAME: NITRIC OXIDE (NO); REGISTERED: UK EU/1/01/194/001 20010801
0560928 2002C/003 Belgium ⤷  Try a Trial 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.