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Last Updated: April 7, 2020

DrugPatentWatch Database Preview

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 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.

Indicators of Generic Entry

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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

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,Inc.et al2006-07-24

See all FORTICAL litigation

Synonyms for FORTICAL
Astronin
Biocalcin
Bionocalcin
C06865
C145H239N43O48S2
Cadens
Calciben
Calcihexal
Calcimar
Calcimar (TN)
Calcimonta
Calcinil
Calcioton
Calcitar
Calcitonin (source)
Calcitonin [USAN:INN:BAN:JAN]
Calcitonin [USAN:USP:INN:BAN:JAN]
Calcitonin salmon (JP17/USAN/INN)
Calcitonin vom lachs
Calcitonin, salmar
CALCITONIN, SALMON
Calcitonin, salmon, for bioassay
Calcitonin,salmon
Calcitonina
Calcitonina [INN-Spanish]
Calcitonine [INN-French]
Calcitonine de saumon
Calcitoninum
Calcitoninum [INN-Latin]
Calcitoran
Calcitrin
Calco
Calogen
Calsynar
Calsynar Lyo L
Caltine
Casalm
Catonin
Cibacalcin
Cibacalcine
Citonina
D00249
DF35I47HCM
EINECS 232-693-2
EINECS 256-342-8
Eptacalcin
Forcaltonin
Fortical (TN)
HSDB 3209
Ipocalcin
Isi-calcin
Kalsimin
Karil
LS-48624
Miacalcic
Miacalcin
Miacalcin (TN)
Miracalcic
Oseototal
Osseocalcina
Osteobion
Osteovis
Ostosalm
Ostostabil
Porostenina
Prontocalcin
Quosten
Riostin
Rulicalcin
Salcat
Salcatonin
Salcatyn
Salmocalcin
Salmofar
Salmon calcitonin
salmon calcitonin (1-32)
Salmon calcitonin I
Salmon calcitonin-(I-32)
SCHEMBL269785
Sical
Stalcin
Staporos
Steocin
synthetic salmon calcitonin
Thyrocalcitonin (source)
Tonocalcin
TZ-CT
Ucecal
UNII-DF35I47HCM
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

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.