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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 patent protection?
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 nine patent family members in fifteen countries.
There are six drug master file entries for nitric oxide.
Summary for nitric oxide
| International Patents: | 109 |
| US Patents: | 21 |
| Tradenames: | 3 |
| Applicants: | 3 |
| NDAs: | 3 |
| Drug Master File Entries: | 6 |
| Bulk Api Vendors: | 12 |
| Clinical Trials: | 870 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for nitric oxide |
| DailyMed Link: | nitric oxide at DailyMed |
Recent Clinical Trials for nitric oxide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute on Aging (NIA) | Early Phase 1 |
| University of Utah | Early Phase 1 |
| New York City Health and Hospitals Corporation | Phase 4 |
Medical Subject Heading (MeSH) Categories for nitric oxide
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 | 020845-002 | Dec 23, 1999 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Mallinckrodt Hosp | INOMAX | nitric oxide | GAS;INHALATION | 020845-002 | Dec 23, 1999 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Praxair Distribution | NOXIVENT | nitric oxide | GAS;INHALATION | 207141-002 | Oct 2, 2018 | AA | RX | No | No | Start Trial | Start Trial | 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 | 020845-003 | 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 |
International Patents for nitric oxide
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2014532523 | Start Trial |
| Australia | 2017201628 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2016064928 | Start Trial |
| Japan | 2016512112 | Start Trial |
| >Country | >Patent Number | >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 | Start Trial | PRODUCT NAME: NITRIC OXIDE (NO); REGISTERED: UK EU/1/01/194/001 20010801 |
| 0560928 | 2002C/003 | Belgium | Start 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 |
