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Last Updated: November 22, 2019

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Calcitonin salmon - Generic Drug Details

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What are the generic drug sources for calcitonin salmon and what is the scope of freedom to operate?

Calcitonin salmon is the generic ingredient in four branded drugs marketed by Sanofi Aventis Us, Igi Labs Inc, Mylan Ireland Ltd, Apotex Inc, Par Pharm, and Upsher Smith Labs, and is included in eight NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for calcitonin salmon. Three suppliers are listed for this compound.

Recent Clinical Trials for calcitonin salmon

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SponsorPhase
University of Missouri-ColumbiaPhase 4
University of MarylandPhase 4
Tarsa Therapeutics, Inc.Phase 3

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Recent Litigation for calcitonin salmon

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District Court Litigation
Case NameDate
Novartis Pharma. v. Apotex Corporation

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Pharmacology for calcitonin salmon
Drug ClassCalcitonin
Paragraph IV (Patent) Challenges for CALCITONIN SALMON
Tradename Dosage Ingredient NDA Submissiondate
MIACALCIN SPRAY, METERED;NASAL calcitonin salmon 020313

US Patents and Regulatory Information for calcitonin salmon

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
Apotex Inc CALCITONIN-SALMON calcitonin salmon SPRAY, METERED;NASAL 076396-001 Nov 17, 2008 AB RX No Yes   Start Trial   Start Trial   Start Trial
Mylan Ireland Ltd MIACALCIN calcitonin salmon SPRAY, METERED;NASAL 020313-002 Aug 17, 1995 DISCN Yes No   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us CALCIMAR calcitonin salmon INJECTABLE;INJECTION 017497-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Igi Labs Inc CALCITONIN-SALMON calcitonin salmon INJECTABLE;INJECTION 073690-001 Apr 14, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Ireland Ltd MIACALCIN calcitonin salmon INJECTABLE;INJECTION 017808-001 Jul 3, 1986 DISCN Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for calcitonin salmon

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Ireland Ltd MIACALCIN calcitonin salmon SPRAY, METERED;NASAL 020313-002 Aug 17, 1995   Start Trial   Start Trial
Mylan Ireland Ltd MIACALCIN calcitonin salmon SPRAY, METERED;NASAL 020313-002 Aug 17, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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