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Last Updated: October 27, 2020

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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 Praxair Distribution, and is included in three NDAs. There are twenty-one 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 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
University of UtahEarly Phase 1
National Institute on Aging (NIA)Early Phase 1
European Research CouncilPhase 4

See all nitric oxide clinical trials

Pharmacology for nitric oxide
Drug ClassVasodilator
Physiological EffectVasodilation
Paragraph IV (Patent) Challenges for NITRIC OXIDE
Tradename Dosage Ingredient NDA Submissiondate
INOMAX GAS;INHALATION nitric oxide 020845 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   Start Trial   Start Trial Y   Start Trial
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 AA RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 AA RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 AA RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 AA RX Yes Yes   Start Trial   Start Trial Y   Start 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 020845-002 Dec 23, 1999   Start Trial   Start Trial
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 020845-003 Dec 23, 1999   Start Trial   Start Trial
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for nitric oxide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0560928 2002C/003 Belgium   Start Trial PRODUCT NAME: NITRIC OXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801
0786264 SPC/GB08/019 United Kingdom   Start Trial PRODUCT NAME: NITRIC OXIDE (NO); REGISTERED: UK 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
Harvard Business School
Dow
Merck
Medtronic
Mallinckrodt

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