TERIPARATIDE Drug Patent Profile

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 16^th, 2023.

Summary for TERIPARATIDE

US Patents:	0
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	151
Drug Prices:	Drug price information for TERIPARATIDE
What excipients (inactive ingredients) are in TERIPARATIDE?	TERIPARATIDE excipients list
DailyMed Link:	TERIPARATIDE at DailyMed

See drug prices for TERIPARATIDE

Recent Clinical Trials for TERIPARATIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Universidad de Valparaiso	Phase 4
Universidade Federal Fluminense	Phase 4
Peking Union Medical College Hospital	N/A

See all TERIPARATIDE clinical trials

Pharmacology for TERIPARATIDE

Drug Class

Parathyroid Hormone Analog

Anatomical Therapeutic Chemical (ATC) Classes for TERIPARATIDE

H05AA	Parathyroid hormones and analogues
H05A	PARATHYROID HORMONES AND ANALOGUES
H05	CALCIUM HOMEOSTASIS
H	Systemic hormonal preparations, excluding sex hormones and insulins

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
Apotex	TERIPARATIDE	teriparatide	SOLUTION;SUBCUTANEOUS	211097-001	Nov 16, 2023	AP	RX	No	No
Teva Pharms Usa	TERIPARATIDE	teriparatide	SOLUTION;SUBCUTANEOUS	208569-001	Nov 16, 2023	AP	RX	No	No

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