Forteo Drug Patent Profile

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

Forteo is a drug marketed by Lilly and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in FORTEO 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 Forteo

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

Summary for Forteo

International Patents:	37
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	73
Patent Applications:	1,432
Drug Prices:	Drug price information for Forteo
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for Forteo
What excipients (inactive ingredients) are in Forteo?	Forteo excipients list
DailyMed Link:	Forteo at DailyMed

See drug prices for Forteo

Recent Clinical Trials for Forteo

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

Sponsor	Phase
RANI Therapeutics	Phase 1
Daniel Horwitz	Phase 4
Radius Health, Inc.	Phase 4

See all Forteo clinical trials

Pharmacology for Forteo

Drug Class

Parathyroid Hormone Analog

Anatomical Therapeutic Chemical (ATC) Classes for Forteo

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 FORTEO

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 Forteo

Forteo is protected by one US patents.

Patents protecting Forteo

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-002	Jun 25, 2008	AP	RX	Yes	Yes			Y
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-001	Nov 26, 2002		DISCN	No	No			Y

Expired US Patents for Forteo

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	021318-001	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
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-002	Jun 25, 2008

EU/EMA Drug Approvals for Forteo

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
Accord Healthcare S.L.U.	Sondelbay	teriparatide	EMEA/H/C/005827 Sondelbay 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	2022-03-24
Sun Pharmaceutical Industries Europe B.V.	Teriparatide Sun	teriparatide	EMEA/H/C/005793 Teriparatide SUN is indicated in adults.Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1). 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 (see section 5.1).	Authorised	no	no	no	2022-11-18

International Patents for Forteo

See the table below for patents covering Forteo around the world.

Country	Patent Number	Title	Estimated Expiration
Ukraine	72884	СТАБИЛИЗИРОВАННЫЕ РАСТВОРЫ ПАРАТИРИНА;СТАБІЛІЗОВАНІ РОЗЧИНИ ПАРАТИРИНУ (STABILIZED SOLUTIONS OF PARATHYRINE)
South Africa	200004993	Method of increasing bone toughness and stiffness and reducing fractures.
European Patent Office	1769804	hPTH(1-34) pour son utilisation dans la prévention ou la sévérité de fractures osseuses chez le mâle humain (hPTH(1-34) for use in preventing or reducing the incidence or severity of vertebral and / or non vertebral fracture in a male human)
South Africa	200606885	Medication dispensing apparatus with spring-driven locking feature enabled by administration of final dose
Portugal	1769804
Israel	136662	PHARMACEUTICAL COMPOSITION CONTAINING PARATHYROID HORMONE, VIALS OR CARTRIDGES CONTAINING THE SAME AND PROCESS FOR THE PREPARATION THEREOF
Spain	2405994