GENOSYL Drug Patent Profile
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When do Genosyl patents expire, and what generic alternatives are available?
Genosyl is a drug marketed by Vero Biotech and is included in one NDA. There are twenty-two patents protecting this drug.
This drug has forty-nine patent family members in five countries.
The generic ingredient in GENOSYL is nitric oxide. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nitric oxide profile page.
DrugPatentWatch® Generic Entry Outlook for Genosyl
Indicators of Generic Entry
Summary for GENOSYL
| International Patents: | 49 |
| US Patents: | 22 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 16 |
| Clinical Trials: | 2 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in GENOSYL? | GENOSYL excipients list |
| DailyMed Link: | GENOSYL at DailyMed |
Recent Clinical Trials for GENOSYL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Geno LLC | Phase 3 |
| Geno LLC | Phase 2 |
Pharmacology for GENOSYL
| Drug Class | Vasodilator |
| Physiological Effect | Vasodilation |
Anatomical Therapeutic Chemical (ATC) Classes for GENOSYL
US Patents and Regulatory Information for GENOSYL
GENOSYL is protected by twenty-two US patents.
Patents protecting GENOSYL
Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
Nitrogen dioxide storage cassette
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Nitrogen dioxide storage device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
Systems and devices for generating nitric oxide
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Nitric oxide therapies
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
Simple nitric oxide generator for ambulatory and/or bedside inhaled no treatment
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Conversion of nitrogen dioxide (NO2) to nitric oxide (NO)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Kit for the conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
Systems and devices for generating nitric oxide
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
Conversion of nitrogen dioxide (NO2) to nitric oxide (NO)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Systems and devices for generating nitric oxide
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Conversion of nitrogen dioxide (NO2) to nitric oxide (NO)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Systems and devices for generating nitric oxide
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD FOR DELIVERING NITRIC OXIDE TO A PATIENT WITH PULMONARY HYPERTENSION OR HYPOXIA
Conversion of nitrogen dioxide (NO2) to nitric oxide (NO)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vero Biotech | GENOSYL | nitric oxide | GAS;INHALATION | 202860-001 | Dec 20, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Vero Biotech | GENOSYL | nitric oxide | GAS;INHALATION | 202860-001 | Dec 20, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Vero Biotech | GENOSYL | nitric oxide | GAS;INHALATION | 202860-001 | Dec 20, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Vero Biotech | GENOSYL | nitric oxide | GAS;INHALATION | 202860-001 | Dec 20, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Vero Biotech | GENOSYL | nitric oxide | GAS;INHALATION | 202860-001 | Dec 20, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 GENOSYL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Vero Biotech | GENOSYL | nitric oxide | GAS;INHALATION | 202860-001 | Dec 20, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for GENOSYL
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Linde Healthcare AB | INOmax | nitric oxide | EMEA/H/C/000337 INOmax, in conjunction with ventilatory support and other appropriate active substances, is indicated:for the treatment of newborn infants ≥34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation;as part of the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation. |
Authorised | no | no | no | 2001-08-01 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for GENOSYL
See the table below for patents covering GENOSYL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 2131903 | CONVERSION DU DIOXYDE D'AZOTE (NO2) EN OXYDE NITRIQUE (NO) (CONVERSION OF NITROGEN DIOXIDE (NO2) TO NITRIC OXIDE (NO)) | ⤷ Try a Trial |
| European Patent Office | 2247381 | CONVERSION DE DIOXYDE D'AZOTE (NO |
⤷ Try a Trial |
| European Patent Office | 2724742 | CONVERSION DE DIOXYDE D'AZOTE (NO2) EN MONOXYDE D'AZOTE (NO) (CONVERSION OF NITROGEN DIOXIDE (NO2) TO NITRIC OXIDE (NO)) | ⤷ Try a Trial |
| European Patent Office | 2328592 | SYSTÈMES ET DISPOSITIFS PERMETTANT LA GÉNÉRATION D'OXYDE NITRIQUE (SYSTEMS AND DEVICES FOR GENERATING NITRIC OXIDE) | ⤷ Try a Trial |
| Japan | 5554723 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for GENOSYL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0560928 | 2002C/003 | Belgium | ⤷ Try a Trial | PRODUCT NAME: NITRIC OXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801 |
| 0786264 | SPC/GB08/019 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: NITRIC OXIDE (NO); REGISTERED: UK 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 verification 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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