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. 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. Six 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:	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
Universidade Federal Fluminense	Phase 4
Universidad de Valparaiso	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

FORTEO is protected by one US patents.

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			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	021318-001	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
EuroGenerics Holdings B.V.	Qutavina	teriparatide	EMEA/H/C/005388Qutavina 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

International Patents for FORTEO

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	505222	Stabilised solution formulations containing a parathyroid hormone (teriparatide), PTH(1-34)
New Zealand	507056	Use of PTH in increasing bone toughness and stiffness and reducing fractures
South Korea	20010032881
Portugal	2266598

Market Dynamics and Financial Trajectory for FORTEO

Last updated: October 10, 2025

Introduction

FORTEO (teriparatide), a recombinant form of parathyroid hormone (PTH), is a growth hormone analog marketed primarily for the treatment of osteoporosis in postmenopausal women and other patients at elevated fracture risk. Approved by the U.S. Food and Drug Administration (FDA) in 2002, FORTEO has carved a niche within the anabolic osteoporosis treatment segment. This analysis examines the current market landscape, key drivers influencing FORTEO’s commercial trajectory, competitive positioning, and future financial outlook.

Market Overview

Osteoporosis Treatment Landscape

Osteoporosis affects over 200 million worldwide, predominantly postmenopausal women and aging populations. The global osteoporosis drugs market was valued at approximately USD 10 billion in 2022, with projected compounded annual growth rates (CAGR) of 3-5% through 2030 [1].

Segment Focus

The pharmaceutical market for osteoporosis comprises antiresorptive agents (bisphosphonates, denosumab) and anabolic agents (teriparatide, abaloparatide, romosozumab). While antiresorptives dominate market share due to long-term safety and cost benefits, anabolic therapies like FORTEO are increasingly valuable for severe cases, glucocorticoid-induced osteoporosis, and patients unresponsive to antiresorptives.

Market Dynamics Influencing FORTEO

Demand Drivers

1. Growing Aging Population: By 2050, individuals aged 65+ will constitute over 16% of the global population, escalating osteoporosis prevalence and demanding more effective therapies [2].

2. Unmet Medical Need: Patients with severe osteoporosis, prior fractures, or inadequate response to antiresorptives benefit significantly from anabolic agents. FORTEO remains a key option pending safety perceptions and contraindications.

3. Clinical Guidelines: Medical guidelines increasingly recommend anabolic therapy for high-risk osteoporosis patients, reinforcing demand [3].

4. Reimbursement Policies: Favorable reimbursement in developed markets bolsters prescriptions, although high treatment costs remain a barrier.

Supply and Competitive Factors

1. Patent Status and Biosimilars: FORTEO's patent expiration in 2019 prompted the launch of biosimilars in certain markets, exerting pressure on pricing [4]. Industry entrants aim to capture market share through competitive pricing and formulary positioning.

2. Alternate Anabolic Agents: Abaloparatide (Tymlos) and romosozumab (Evenity) offer competitive options with differing administration routes and safety profiles. For example, romosozumab exhibits combined anabolic and antiresorptive effects but carries cardiovascular risk concerns.

3. Safety and Tolerability: The boxed warning for osteosarcoma risk limits long-term use, affecting market penetration, especially among older patients with comorbidities.

Regulatory and Prescribing Trends

• Guidelines Integration: Adoption varies worldwide, depending on local guidelines; for instance, the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletel Diseases (ESCEO) recommends anabolic agents for severe cases.

• Market Penetration: Despite clinical benefits, prescribed patient numbers remain modest relative to the osteoporosis population, owing to treatment complexity, cost, and safety considerations.

Financial Trajectory of FORTEO

Historical Revenue Performance

Since its launch in 2002, FORTEO experienced rapid initial growth, peaking around USD 600 million in annual sales by the late 2000s. However, subsequent years saw decline, primarily due to patent expiry, biosimilar entry, and safety concerns.

Current Revenue Estimates

Based on industry reports, global sales are estimated between USD 150–200 million in 2022, with North American markets being primary revenue contributors. European markets exhibit variable adoption, influenced by local regulatory decisions.

Forecasted Growth and Challenges

• Short to Medium Term: The market for FORTEO is expected to see a gradual decline unless new indications, formulations, or safety profiles expand its use.

• Potential Upside: Ongoing research into combination therapies, extended-term safety data, and new formulations (e.g., shorter administration durations) could stabilize or boost revenue.

• Market Share Shifts: Biosimilar competition will likely erode pricing power and volumes; thus, revenues are expected to plateau or decline unless countered by differentiated offerings.

Strategic Opportunities

• Indication Expansion: Investigating FORTEO’s efficacy in other indications such as glucocorticoid-induced osteoporosis or fracture prevention could open additional revenue streams.

• Formulation Innovations: Development of longer-acting formulations or administration via alternative routes (e.g., transdermal patches) may enhance patient adherence and expand market share.

• Lifecycle Management: Licensing agreements, strategic collaborations, or marketing campaigns focused on high-risk populations could mitigate declining sales.

Market Risks and External Factors

1. Safety Concerns: The boxed warning for osteosarcoma remains a significant barrier, influencing prescriber comfort and patient acceptance.

2. Pricing and Reimbursement Pressures: Payers increasingly demand cost-effectiveness evidence, which could suppress sales or force price reductions.

3. Regulatory Environment: Evolving policies around biosimilar substitution and off-label uses may impact sales trajectory.

4. Competing Agents: The emergence of newer anabolic agents with favorable safety profiles could diminish FORTEO’s market share.

Conclusion and Outlook

FORTEO’s position within osteoporosis therapeutics is challenged by biosimilar competition, safety concerns, and evolving clinical guidelines. Nevertheless, its proven efficacy in managing severe osteoporosis preserves a niche among high-risk populations. Financially, revenues are expected to plateau or decline without significant label extensions or formulation innovations, emphasizing the need for strategic lifecycle management.

Key Takeaways

• Market Positioning: FORTEO is primarily used in high-risk osteoporosis cases; its usage remains constrained by safety concerns and competition.

• Revenue Trends: Existing revenues are declining post-patent expiry, with a forecasted gradual decrease unless new indications or formulations are introduced.

• Competitive Landscape: Biosimilars internally pressurize pricing, while newer agents like romosozumab offer alternative options.

• Growth Strategies: Expanding indications, developing next-generation formulations, and enhancing clinician awareness are critical to maintaining relevance.

• Industry Implications: Biopharma firms must innovate in safety, efficacy, and delivery to sustain anabolic therapies' profitability amid patent cliffs and competitive shifts.

References

1. [GlobalData Reports, 2022]
2. United Nations Department of Economic and Social Affairs, 2022
3. National Osteoporosis Foundation Guidelines, 2022
4. FDA Patent and Exclusivity Data, 2019