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.
Summary for nitric oxide
International Patents: | 154 |
US Patents: | 37 |
Tradenames: | 3 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 6 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 16 |
Clinical Trials: | 968 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for nitric oxide |
What excipients (inactive ingredients) are in nitric oxide? | nitric oxide excipients list |
DailyMed Link: | nitric oxide at DailyMed |
Recent Clinical Trials for nitric oxide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Simon Fraser University | Phase 2 |
Medical College of Wisconsin | Early Phase 1 |
Massachusetts General Hospital | Early Phase 1 |
Pharmacology for nitric oxide
Drug Class | Vasodilator |
Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for nitric oxide
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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