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Last Updated: November 22, 2024

TERIPARATIDE Drug Patent Profile


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Which patents cover Teriparatide, and when can generic versions of Teriparatide launch?

Teriparatide is a drug marketed by Almaject, Apotex, and Teva Pharms Usa. and is included in three NDAs.

The generic ingredient in TERIPARATIDE is teriparatide. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the teriparatide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Teriparatide

A generic version of TERIPARATIDE was approved as teriparatide by APOTEX on November 16th, 2023.

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Summary for TERIPARATIDE
Drug patent expirations by year for TERIPARATIDE
Drug Prices for TERIPARATIDE

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Recent Clinical Trials for TERIPARATIDE

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SponsorPhase
Universidade Federal FluminensePhase 4
Universidad de ValparaisoPhase 4
Peking Union Medical College HospitalN/A

See all TERIPARATIDE clinical trials

Pharmacology for TERIPARATIDE
Paragraph IV (Patent) Challenges for TERIPARATIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FORTEO Injection teriparatide 250 mcg/mL, 2.4 mL prefilled Pen 021318 1 2015-07-27

US Patents and Regulatory Information for TERIPARATIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Almaject TERIPARATIDE teriparatide SOLUTION;SUBCUTANEOUS 218771-001 Jun 4, 2024 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apotex TERIPARATIDE teriparatide SOLUTION;SUBCUTANEOUS 211097-001 Nov 16, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa TERIPARATIDE teriparatide SOLUTION;SUBCUTANEOUS 208569-001 Nov 16, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for TERIPARATIDE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
STADA Arzneimittel AG Movymia teriparatide EMEA/H/C/004368
Movymia is indicated in adults.Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.
Authorised no yes no 2017-01-11
Eli Lilly Nederland B.V. Forsteo teriparatide EMEA/H/C/000425
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and nonvertebral fractures but not hip fractures has been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.
Authorised no no no 2003-06-10
Gedeon Richter Plc. Terrosa teriparatide EMEA/H/C/003916
Terrosa is indicated in adults.Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.
Authorised no yes no 2017-01-04
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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