FOSDENOPTERIN HYDROBROMIDE - Generic Drug Details
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What are the generic sources for fosdenopterin hydrobromide and what is the scope of patent protection?
Fosdenopterin hydrobromide
is the generic ingredient in one branded drug marketed by Sentynl Theraps Inc and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Fosdenopterin hydrobromide has ten patent family members in ten countries.
One supplier is listed for this compound.
Summary for FOSDENOPTERIN HYDROBROMIDE
| International Patents: | 10 |
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| What excipients (inactive ingredients) are in FOSDENOPTERIN HYDROBROMIDE? | FOSDENOPTERIN HYDROBROMIDE excipients list |
| DailyMed Link: | FOSDENOPTERIN HYDROBROMIDE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FOSDENOPTERIN HYDROBROMIDE
Generic Entry Date for FOSDENOPTERIN HYDROBROMIDE*:
Constraining patent/regulatory exclusivity:
INDICATED TO REDUCE THE RISK OF MORTALITY IN PATIENTS WITH MOLYBDENUM COFACTOR DEFICIENCY (MOCD) TYPE A Dosage:
POWDER;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for FOSDENOPTERIN HYDROBROMIDE
| Drug Class | Cyclic Pyranopterin Monophosphate |
Anatomical Therapeutic Chemical (ATC) Classes for FOSDENOPTERIN HYDROBROMIDE
US Patents and Regulatory Information for FOSDENOPTERIN HYDROBROMIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sentynl Theraps Inc | NULIBRY | fosdenopterin hydrobromide | POWDER;INTRAVENOUS | 214018-001 | Feb 26, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sentynl Theraps Inc | NULIBRY | fosdenopterin hydrobromide | POWDER;INTRAVENOUS | 214018-001 | Feb 26, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sentynl Theraps Inc | NULIBRY | fosdenopterin hydrobromide | POWDER;INTRAVENOUS | 214018-001 | Feb 26, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sentynl Theraps Inc | NULIBRY | fosdenopterin hydrobromide | POWDER;INTRAVENOUS | 214018-001 | Feb 26, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for FOSDENOPTERIN HYDROBROMIDE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Slovenia | 1664317 | ⤷ Sign Up | |
| Germany | 102004004642 | Produktion, Gewinnung und therapeutischer Einsatz des Molybdopterin-Derivats Precursor Z zur Therapie der Stoffwechselerkrankung humaner Molybdäncofaktor-Defizienz und anderer assoziierter Krankheiten | ⤷ Sign Up |
| Poland | 1664317 | ⤷ Sign Up | |
| European Patent Office | 1664317 | Utilisation du précurseur Z pour produire un agent servant à traiter la déficience humaine en cofacteur molybdène (Use of precursor Z for the production of a means for therapy of human molybdenum cofactor deficiency) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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.
ISSN: 2162-2639
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