Fortical® (calcitonin salmon)

aBL 021406

Fortical® (calcitonin salmon)

aBL 021406

U.S. License Holder:

Upsher-Smith

Date of License:

August-12-2005

Last Update:

Mar-15-2025

approved_indications FDA-Approved Indications

FORTICAL (calcitonin salmon) is a calcitonin indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause when alternative treatments are not suitable.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:02-cv-08917 (S.D.N.Y.)

U.S. Patent Nos.
5,733,569 (Galenic Compositions comprising Calcitonin and their Use) 5,759,565 (Galenic Compositions comprising Calcitonin and their Use)

Plaintiffs
Novartis AG; Novartis International Pharmaceutical Ltd.; Novartis Pharma AG; Novartis Pharmaceuticals Corp.

Defendants
Apotex Corp.; Apotex Inc.; Novex Pharma

Status
Stipulated Dismissal

BPCIA
N

1:06-cv-05571 (S.D.N.Y.)

U.S. Patent Nos.
6,440,392 [RE40,812] (Nasal Calcitonin Formulations)

Plaintiffs
Unigene Laboratories, Inc.; Upsher-Smith Laboratories, Inc.

Defendants
Apotex Corp.; Apotex Inc.

Federal Circuit Appeal(s)
10-1006

Supreme Court Appeal(s)
11-879 (U.S.)

Status
Challenged Claims Non-Obvious and Infringed; Affirmed on Appeal

BPCIA
N

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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