TERIPARATIDE - Generic Drug Details

What are the generic sources for teriparatide and what is the scope of freedom to operate?

Teriparatide is the generic ingredient in four branded drugs marketed by Alvogen, Lilly, Almaject, Apotex, Teva Pharms Usa, and Sanofi Aventis Us, and is included in six NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Teriparatide has thirty-seven patent family members in twenty-five countries.

There are four drug master file entries for teriparatide. Five suppliers are listed for this compound.

Summary for TERIPARATIDE

International Patents:	37
US Patents:	1
Tradenames:	4
Applicants:	6
NDAs:	6
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	151
Drug Prices:	Drug price trends 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
Alvogen	BONSITY	teriparatide	SOLUTION;SUBCUTANEOUS	211939-001	Oct 4, 2019		RX	No	No
Sanofi Aventis Us	PARATHAR	teriparatide acetate	INJECTABLE;INJECTION	019498-001	Dec 23, 1987		DISCN	No	No
Apotex	TERIPARATIDE	teriparatide	SOLUTION;SUBCUTANEOUS	211097-001	Nov 16, 2023	AP	RX	No	No
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-001	Nov 26, 2002		DISCN	No	No			Y
Almaject	TERIPARATIDE	teriparatide	SOLUTION;SUBCUTANEOUS	218771-001	Jun 4, 2024		RX	Yes	Yes

Expired US Patents for TERIPARATIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-001	Nov 26, 2002
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-002	Jun 25, 2008
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-002	Jun 25, 2008
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-002	Jun 25, 2008
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-001	Nov 26, 2002

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
EuroGenerics Holdings B.V.	Qutavina	teriparatide	EMEA/H/C/005388 Qutavina 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 have been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.	Withdrawn	no	yes	no	2020-08-27
Theramex Ireland Limited	Livogiva	teriparatide	EMEA/H/C/005087 Livogiva 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 have been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.	Authorised	no	yes	no	2020-08-27

International Patents for TERIPARATIDE

Country	Patent Number	Title	Estimated Expiration
Norway	20064955
Eurasian Patent Organization	009497	УСТРОЙСТВО ДЛЯ ДОЗИРОВАНИЯ ЛЕКАРСТВЕННЫХ ПРЕПАРАТОВ С ПРУЖИННЫМ БЛОКИРУЮЩИМ УСТРОЙСТВОМ, ПРИВОДИМЫМ В ДЕЙСТВИЕ ПРИ ВВЕДЕНИИ ПОСЛЕДНЕЙ ДОЗЫ (MEDICATION DISPENSING APPARATUS WITH SPRING-DRIVEN LOCKING FEATURE ENABLED BY ADMINISTRATION OF FINAL DOSE)
Israel	177829	MEDICATION DISPENSING APPARATUS WITH SPRING-DRIVEN LOCKING FEATURE ENABLED BY ADMINISTRATION OF FINAL DOSE
Slovenia	1732629
Denmark	1732629