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Last Updated: July 2, 2020

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FORTICAL Drug Profile


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When do Fortical patents expire, and when can generic versions of Fortical launch?

Fortical 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.

This drug has seven patent family members in five countries.

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.

US ANDA Litigation and Generic Entry Outlook for Fortical

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 2, 2021. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for FORTICAL
International Patents:7
US Patents:3
Applicants:1
NDAs:1
Bulk Api Vendors: 6
Clinical Trials: 1
Patent Applications: 1
Formulation / Manufacturing:see details
DailyMed Link:FORTICAL at DailyMed
Drug patent expirations by year for FORTICAL
Generic Entry Opportunity Date for FORTICAL
Generic Entry Date for FORTICAL*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for FORTICAL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)N/A
Yale UniversityN/A

See all FORTICAL clinical trials

Paragraph IV (Patent) Challenges for FORTICAL
Tradename Dosage Ingredient NDA Submissiondate
FORTICAL SPRAY, METERED;NASAL calcitonin salmon recombinant 021406 2006-03-29

US Patents and Regulatory Information for FORTICAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Upsher Smith Labs FORTICAL calcitonin salmon recombinant SPRAY, METERED;NASAL 021406-001 Aug 12, 2005 DISCN No No   Start Trial   Start Trial Y   Start Trial
Upsher Smith Labs FORTICAL calcitonin salmon recombinant SPRAY, METERED;NASAL 021406-001 Aug 12, 2005 DISCN No No   Start Trial   Start Trial Y   Start Trial
Upsher Smith Labs FORTICAL calcitonin salmon recombinant SPRAY, METERED;NASAL 021406-001 Aug 12, 2005 DISCN No 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

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Serving leading biopharmaceutical companies globally:

Merck
Medtronic
Moodys
Dow
AstraZeneca
McKinsey

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