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Last Updated: October 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021406

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NDA 021406 describes FORTICAL, which is a drug marketed by Upsher Smith Labs and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FORTICAL profile page.

The generic ingredient in FORTICAL is calcitonin salmon recombinant. There are fourteen drug master file entries for this compound. Additional details are available on the calcitonin salmon recombinant profile page.
Summary for 021406
Tradename:FORTICAL
Applicant:Upsher Smith Labs
Ingredient:calcitonin salmon recombinant
Patents:3
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021406
Generic Entry Date for 021406*:
Constraining patent/regulatory exclusivity:
Dosage:
SPRAY, METERED;NASAL

*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.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SPRAY, METERED;NASALStrength200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 12, 2005TE:RLD:No
Patent:  Start TrialPatent Expiration:Feb 2, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:NASAL ADMINISTRATION
Patent:  Start TrialPatent Expiration:Feb 2, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Feb 2, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:NASAL ADMINISTRATION

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