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Nitric oxide - Generic Drug Details
What are the generic sources for nitric oxide and what is the scope of nitric oxide freedom to operate?
Nitric oxide
is the generic ingredient in two branded drugs marketed by Mallinckrodt Hosp and Praxair Distribution, and is included in two NDAs. There are fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.There are six drug master file entries for nitric oxide. Two suppliers are listed for this compound.
Summary for nitric oxide
| US Patents: | 15 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: | 6 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 11 |
| Clinical Trials: | 757 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for nitric oxide |
| DailyMed Link: | nitric oxide at DailyMed |
Pharmacology for nitric oxide
| Drug Class | Vasodilator |
| Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for nitric oxide
Synonyms for nitric oxide
| (.)NO |
| (NO)(.) |
| [NO] |
| 10102-43-9 |
| 31C4KY9ESH |
| AC1L3QHF |
| C00533 |
| CHEBI:16480 |
| CHEMBL1200689 |
| CTK0H7679 |
| D00074 |
| D0A5FM |
| D0W2BD |
| DB00435 |
| DTXSID1020938 |
| EDRF |
| Endogenous Nitrate Vasodilator |
| Endothelium-Derived Nitric Oxide |
| endothelium-derived relaxing factor |
| Endothelium-derived relaxing factor (EDRF) |
| INOmax |
| INOmax (TN) |
| Mononitrogen monoxide |
| Monoxide, Mononitrogen |
| Monoxide, Nitrogen |
| monoxido de nitrogeno |
| monoxyde d'azote |
| Nitrate Vasodilator, Endogenous |
| Nitric oxide (JAN) |
| Nitric oxide trimer |
| Nitric oxide, 98.5% |
| Nitric Oxide, Endothelium Derived |
| Nitric Oxide, Endothelium-Derived |
| NITRIC-OXIDE |
| nitrogen monooxide |
| nitrogen monoxide |
| nitrogen protoxide |
| Nitrogen(II) oxide |
| Nitrosoradical |
| nitrosyl |
| Nitrosyl radical |
| Nitroxide radical |
| NO(.) |
| NO() |
| OHM 11771 |
| Oxide, Nitric |
| oxido de nitrogeno(II) |
| oxido nitrico |
| oxidonitrogen(.) |
| Oxidonitrogen() |
| oxoazanyl |
| oxyde azotique |
| Stickstoff(II)-oxid |
| Stickstoffmonoxid |
| Vasodilator, Endogenous Nitrate |
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 | 020845-003 | Dec 23, 1999 | AA | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Mallinckrodt Hosp | INOMAX | nitric oxide | GAS;INHALATION | 020845-002 | Dec 23, 1999 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Mallinckrodt Hosp | INOMAX | nitric oxide | GAS;INHALATION | 020845-003 | Dec 23, 1999 | AA | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| 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 | ➤ Sign Up | ➤ Sign Up |
| Mallinckrodt Hosp | INOMAX | nitric oxide | GAS;INHALATION | 020845-003 | Dec 23, 1999 | ➤ Sign Up | ➤ Sign Up |
| Mallinckrodt Hosp | INOMAX | nitric oxide | GAS;INHALATION | 020845-002 | Dec 23, 1999 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for nitric oxide
Supplementary Protection Certificates for nitric oxide
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C/GB08/019 | United Kingdom | ➤ Sign Up | PRODUCT NAME: NITRIC OXIDE (NO); REGISTERED: UK EU/1/01/194/001 20010801 |
| 02C/003 | Belgium | ➤ Sign Up | PRODUCT NAME: NITRIC OXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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