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Nitric oxide - Generic Drug Details
What are the generic drug sources for nitric oxide and what is the scope of patent protection?
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.Nitric oxide has seventy-nine patent family members in fifteen countries.
There are six drug master file entries for nitric oxide. Two suppliers are listed for this compound.
Summary for nitric oxide
| International Patents: | 79 |
| US Patents: | 15 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: | 6 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 11 |
| Clinical Trials: | 809 |
| 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 |
|---|---|
| Allergy- and pulmonary Clinic, Vanloese. | Phase 4 |
| Lund University | Phase 4 |
| ALK-Abelló A/S | Phase 4 |
Recent Litigation for nitric oxide
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Mallinckrodt Hospital Products IP Ltd. v. Praxair Distribution Inc. | 2016-07-08 |
| Mallinckrodt Hospital Products IP Ltd. v. Praxair Distribution Inc. | 2015-02-19 |
See all nitric oxide litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Praxair Distribution, Inc. | 2016-03-23 |
| Praxair Distribution, Inc. | 2015-03-16 |
| Praxair Distribution, Inc. | 2015-01-05 |
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 |
| AC1L3QHF |
| C00533 |
| CHEBI:16480 |
| CHEMBL1200689 |
| CTK0H7679 |
| D00074 |
| DB00435 |
| DTXSID1020938 |
| EDRF |
| endothelium-derived relaxing factor |
| INOmax (TN) |
| Mononitrogen monoxide |
| monoxido de nitrogeno |
| monoxyde d'azote |
| Nitric oxide (JAN) |
| Nitric oxide trimer |
| Nitric oxide, 98.5% |
| nitrogen monooxide |
| nitrogen monoxide |
| nitrogen protoxide |
| Nitrogen(II) oxide |
| Nitrosoradical |
| nitrosyl |
| Nitrosyl radical |
| NO(.) |
| OHM 11771 |
| oxido de nitrogeno(II) |
| oxido nitrico |
| oxidonitrogen(.) |
| oxoazanyl |
| oxyde azotique |
| Stickstoff(II)-oxid |
| Stickstoffmonoxid |
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 | 020845-003 | 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 | 020845-002 | 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 | ||
| >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 | 020845-002 | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for nitric oxide
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2018204804 | Start Trial |
| Japan | 2014532523 | Start Trial |
| Portugal | 2661300 | Start Trial |
| Denmark | 2661300 | Start Trial |
| Australia | 2015202617 | 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 |
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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 verifification 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.
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