FORTEO Drug Patent Profile

When do Forteo patents expire, and when can generic versions of Forteo launch?

Forteo is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in FORTEO is teriparatide. There are four drug master file entries for this compound. Eight 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

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	76
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
QuadMedicine	PHASE1
Universidad de Valparaiso	Phase 4
Universidade Federal Fluminense	Phase 4

See all FORTEO clinical trials

Pharmacology for FORTEO

Drug Class

Parathyroid Hormone Analog

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

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
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-001	Nov 26, 2002		DISCN	No	No

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	021318-002	Jun 25, 2008
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-001	Nov 26, 2002

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/004368Movymia 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/000425Treatment 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/003916Terrosa 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

International Patents for FORTEO

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

Country	Patent Number	Title	Estimated Expiration
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)
Spain	2621653
Peru	20001089	METODO PARA INCREMENTAR LA DUREZA Y RESISTENCIA OSEA

Market Dynamics and Financial Trajectory for FORTEO (Teriparatide)

Last updated: March 9, 2026

What is the current market status of FORTEO (Teriparatide)?

FORTEO (teriparatide) is a recombinant form of parathyroid hormone used to treat osteoporosis, primarily in cases with high fracture risk. It has maintained a niche position within the bone health segment dominated by bisphosphonates and newer agents such as denosumab and anabolic therapies.

As of 2022, the global osteoporosis drug market was valued at approximately USD 13 billion, with FORTEO representing a small fraction, estimated around USD 200-300 million in annual sales (IQVIA, 2022). Its sales have experienced slight decline due to market competition and the expiration of patent protections in key regions.

What factors influence the market dynamics of FORTEO?

Patent and Regulatory Environment

• The original patent for FORTEO expired in 2019 in the United States, allowing biosimilar competition. The first biosimilar was approved in the US in 2020, leading to price erosion and volume increases for generics.
• Regulatory pathways for biosimilars are established globally, with approvals in Europe, Japan, and other markets, impacting pricing and market share.

Clinical Positioning and Competitive Landscape

• FORTEO is specific to high-risk patients, with a treatment window limit of 2 years.
• Competitors include bisphosphonates (alendronate, zoledronic acid), denosumab, and anabolic agents like abaloparatide.
• Recent advances in oral medications and long-term bisphosphonate use influence the demand for injectable therapies like FORTEO.

Pricing and Reimbursement

• In the US, prescription costs for FORTEO ranged from USD 1,800 to USD 2,200 per month (GoodRx, 2022).
• Reimbursement policies in Europe and Japan provide variable coverage, influencing patient access and prescribing habits.

Market Penetration and Utilization Patterns

• Usage is concentrated among patients with severe osteoporosis or those unresponsive to other therapies.
• Application in hospital settings restricts broader outpatient adoption.

How is the financial trajectory for FORTEO shaping up?

Sales Trends

• Historically, annual sales peaked around USD 300 million in 2012-2013.
• Post-patent expiry, sales declined gradually, reaching approximately USD 200 million by 2021.
• The advent of biosimilars reduced prices by an estimated 30-50%, impacting revenue.

Impact of Biosimilars

• Biosimilars captured an estimated 20-30% of the market share in the US by 2022.
• Price competition has led to a decline in average selling price (ASP), with some markets reporting reductions of 50% compared to the original branded product.

Pipeline and Lifecycle Management

• Novo Nordisk, the manufacturer, has initiated efforts to expand indications, such as for glucocorticoid-induced osteoporosis.
• Developing combination formulations and extended dosing regimens could extend product lifecycle.

Future Outlook

• Market analysts project a decline in FORTEO sales to around USD 150 million globally by 2025.
• Industry trends favor oral alternatives and long-acting injectables, which may further erode FORTEO's market share.
• Enhanced access through biosimilar uptake and new indications may mitigate revenue decline.

What is the risk profile for investors or R&D stakeholders?

• Patent expiry and biosimilar entry pose significant revenue risks.
• Competition from emerging anabolic therapies and oral medications could further diminish market relevance.
• However, potential new indications and formulation innovations could buffer decline and open new revenue streams.

Key Tables and Data

Year	Estimated Global Sales (USD millions)	Market Share Impact	Notes
2012	300	-	Peak sales period
2019	280	Patent protected	Pre-patent expiry sales
2021	200	Biosimilar entry	Launch of biosimilars, pricing pressure
2025	150 (projected)	Decline	Market trend forecast

Key Takeaways

• FORTEO's market has contracted due to patent expirations, biosimilar competition, and evolving treatment guidelines.
• Annual sales are declining, with projections to reach approximately USD 150 million globally by 2025.
• Biosimilar penetration and price erosion challenge profit margins.
• Strategic efforts include expanding indications and formulation innovations to extend lifecycle.
• The competitive landscape increasingly favors oral and long-acting therapies, pressing FORTEO’s market position.

FAQs

1. How does biosimilar competition affect FORTEO sales?
Biosimilars entering the market have captured a growing share—up to 30%—leading to substantial price reductions and volume increases that diminish overall revenues.

2. What are the primary clinical uses of FORTEO?
It treats severe osteoporosis in patients at high risk for fractures, typically those unresponsive to other therapies or with multiple fracture history.

3. Are there efforts to extend FORTEO's lifecycle?
Yes. Initiatives include expanding indications, developing combination therapies, and creating extended dosing schedules to retain market relevance.

4. How does FORTEO compare financially to other osteoporosis treatments?
Compared to bisphosphonates, FORTEO’s annual revenue is lower, with a narrower target population and a more costly administration route.

5. What is the outlook for future revenue?
Sales are expected to decline further unless new indications, formulations, or market strategies are implemented, projected to reach USD 150 million globally by 2025.

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References

[1] IQVIA. (2022). Global osteoporosis drug market analysis.
[2] GoodRx. (2022). Cost analysis of FORTEO (teriparatide).
[3] FDA. (2020). Approval of biosimilar teriparatide formulations in the United States.