Forteo® (teriparatide)

NDA 021318 [505(b)(2)]

Forteo® (teriparatide)

NDA 021318 [505(b)(2)]

U.S. License Holder:

Eli Lilly

Date of License:

November-26-2002

Last Update:

November-30-2018

approved_indications FDA-Approved Indications


FORTEO (teriparatide) is recombinant human parathyroid hormone analog (1-34), [rhPTH(1-34)] indicated for:

Treatment of postmenopausal women with osteoporosis at high risk for fracture;

Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture;

Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In The E.U.

Movymia (STADA Arzneimittel) (January-2017)
Terrosa (Gedeon Richter) (January-2017)

approved_indications U.S. Patent Litigations

PACER

Case No(s):

U.S. Patent Nos.
6,770,623 (Stabilized Teriparatide Solutions) 6,977,077 (Method of Increasing Bone Toughness and Stiffness and Reducing Fractures) 7,144,861 (Stabilized Teriparatide Solutions) 7,163,684 (Method of Increasing Bone Toughness and Stiffness and Reducing Fractures) 7,351,414 (Method of Reducing the Risk of Bone Fracture) 7,517,334 (Medication Dispensing Apparatus with Spring-Driven Locking Feature Enabled By Administration of Final Dose) 7,550,434 (Stabilized Teriparatide Solutions)

Plaintiffs
Eli Lilly and Co.

Defendants
Teva Pharmaceutical Industries Ltd; Teva Pharmaceuticals USA, Inc.

Status
Dismissed (Settled)

BPCIA
N

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Venable Fitzpatrick’s BiologicsHQ Monthly Injection – January 2018 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. February 7, 2018

Methodology

Information contained in the Venable Fitzpatrick 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 Fitzpatrick BiologicsHQ database.

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