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INOMAX Drug Profile
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» See Plans and PricingWhen do Inomax patents expire, and when can generic versions of Inomax launch?
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 eighty-five 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.
US ANDA Litigation and Generic Entry Outlook for Inomax
Inomax was eligible for patent challenges on December 23, 2003.
There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for INOMAX
| International Patents: | 85 |
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 8 |
| Clinical Trials: | 14 |
| Patent Applications: | 188 |
| 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 |
|---|---|
| Blood Center of Wisconsin | Phase 2/Phase 3 |
| Medical College of Wisconsin | Phase 2/Phase 3 |
| Clinical & Translational Science Institute of Southeast Wisconsin | Phase 2/Phase 3 |
Pharmacology for INOMAX
| Drug Class | Vasodilator |
| Physiological Effect | Vasodilation |
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 | |||
| 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 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 | 020845-002 | 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 |
| 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 INOMAX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Africa | 9407680 | Start Trial |
| World Intellectual Property Organization (WIPO) | 9400180 | Start Trial |
| Mexico | 346401 | Start Trial |
| New Zealand | 707513 | Start Trial |
| Japan | 2004167284 | Start Trial |
| China | 103458951 | Start Trial |
| Mexico | 2015012179 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for INOMAX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0786264 | CA 2008 00019 | Denmark | Start Trial | |
| 1516639 | 07C0080 | France | Start Trial | PRODUCT NAME: MONOXYDE D AZOTE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801 |
| 1516639 | C300327 | Netherlands | Start Trial | PRODUCT NAME: STIKSTOFMONOXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801 |
| 0786264 | 2008C/013 | Belgium | Start Trial | PRODUCT NAME: INOMAX-MONOXYDE D AZOTE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801 |
| 1516639 | 91404 | Luxembourg | Start Trial | 91404, EXPIRES: 20160801 |
| 1516639 | CA 2007 00072 | Denmark | Start Trial | |
| 0786264 | 91423 | Luxembourg | Start Trial | 91423, EXPIRES: 20160801 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
