Forteo® (teriparatide)

NDA 021318

Forteo® (teriparatide)

NDA 021318

U.S. License Holder:

Eli Lilly

Date of License:

November-26-2002

Last Update:

Dec-15-2024

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 aBLA / 505(b)(2) Activity

aBLA / 505(b)(2) Approved by FDA

Bonsity: Pfenex / Alvogen (October-2019); Teriparatide Teva: Teva (November-2023) Teriparatide Apotex: Apotex / Ambio (November-2023)

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Apo-teriparatide (Apotex) (May-2020)
Osnuvo (Avir Pharma) (January-2020)
Teva-teriparatide (Teva) (June-2020)

Biosimilars Approved In The E.U.

Kauliv (Strides Pharma) (January-2023)
Livogiva (Theramex Ireland Limited /Pfenex) (August-2020)
Movymia (STADA Arzneimittel) (January-2017)
Sondelbay (Accord Healthcare) (March-2022)
Teriparatide Sun (Sun Pharmaceutical) (Novmber-2022)
Terrosa (Gedeon Richter) (January-2017)

Biosimilars Approved In Australia

Teriparatide GH® / Teriparatide LAPL® / Teriparatide LUPIN® (Generic Health) (April-2023)
Teriparatide RBX / Teriparatide SUN (Sun Pharma) (May-2024)
Terrosa® (Gedeon Richter) (December-2020)

Biosimilars Approved In Japan

Teriparatide BS (Gedeon Richter Plc / Mochida Pharmaceutical Co., Ltd.) (September-2019)

Biosimilars Approved In South Korea

Teribone (Dong-A St. Co., Ltd.) (November-2015)
Terrosa (Daewon Pharmaceutical) (November-2019)

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:16-cv-00596 (S.D. Ind.)

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

1:21-cv-01922 (S.D. Ind.)

U.S. Patent Nos.
7,517,334 (Medication Dispensing Apparatus with Spring-Driven Locking Feature Enabled by Administration of Final Dose)

Plaintiffs
Amphastar Pharmaceuticals, Inc.

Defendants
Eli Lilly and Co.

Status
Consent Judgment (Not Infringed)

BPCIA
N

1:22-cv-01354 (D. Del.)

U.S. Patent Nos.
7,517,334 (Medication Dispensing Apparatus with Spring-Driven Locking Feature Enabled by Administration of Final Dose)

Plaintiffs
Eli Lilly and Co.

Defendants
Dr. Reddy's Laboratories Ltd.; Dr. Reddy's Laboratories, Inc.

Status
Consent Judgment (Not Infringed)

BPCIA
N

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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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