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Last Updated: January 22, 2020

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FORTICAL Drug Profile

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Which patents cover Fortical, and what generic alternatives are available?

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

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Fortical was eligible for patent challenges on December 31st, 1968.

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

There have been two 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.

Drug patent expirations by year for FORTICAL
Generic Entry Opportunity Date for FORTICAL
Generic Entry Date for FORTICAL*:
Constraining patent/regulatory exclusivity:

*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

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

See all FORTICAL clinical trials

Recent Litigation for FORTICAL

Identify potential future generic entrants

District Court Litigation
Case NameDate
Unigene Laboratories, Inc. v. Apotex, Inc.2007-09-04
Unigene Laboratories, Inc. v. Apotex, al2006-07-24

See all FORTICAL litigation

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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