DrugPatentWatch Database Preview
INOMAX Drug Profile
When do Inomax patents expire, and what generic alternatives are available?
Inomax is a drug marketed by Mallinckrodt Hosp and is included in one NDA. There are fifteen patents protecting this drug and one Paragraph IV challenge.
This drug has seventy-nine patent family members in fifteen countries.
The generic ingredient in INOMAX is nitric oxide. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nitric oxide profile page.
Summary for INOMAX
| International Patents: | 79 |
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 11 |
| Clinical Trials: | 14 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for INOMAX |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for INOMAX |
| DailyMed Link: | INOMAX at DailyMed |
Recent Clinical Trials for INOMAX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Clinical & Translational Science Institute of Southeast Wisconsin | Phase 2/Phase 3 |
| Mallinckrodt | Phase 2/Phase 3 |
| Blood Center of Wisconsin | Phase 2/Phase 3 |
Recent Litigation for INOMAX
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 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Praxair Distribution, Inc. | 2016-03-23 |
| Praxair Distribution, Inc. | 2015-03-16 |
| Praxair Distribution, Inc. | 2015-01-05 |
Pharmacology for INOMAX
| Drug Class | Vasodilator |
| Physiological Effect | Vasodilation |
Synonyms for INOMAX
| (.)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 |
| 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 INOMAX
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| INOMAX | GAS;INHALATION | nitric oxide | 020845 | 2014-05-20 |
US Patents and Regulatory Information for INOMAX
| 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 | 020845-002 | 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 | |||
| >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 INOMAX
| 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 | 020845-003 | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for INOMAX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 2016010359 | Start Trial |
| China | 106662559 | Start Trial |
| Australia | 2017202301 | Start Trial |
| Japan | 2019013763 | Start Trial |
| Japan | 2017507329 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for INOMAX
| 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 |
