FORTEO Drug Patent Profile

Which patents cover Forteo, and what generic alternatives are available?

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:	74
Patent Applications:	1,117
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
Universidad de Valparaiso	Phase 4
Universidade Federal Fluminense	Phase 4
RANI Therapeutics	Phase 1

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	7,517,334		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	7,163,684
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-002	Jun 25, 2008	7,351,414
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-001	Nov 26, 2002	7,144,861
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-002	Jun 25, 2008	6,770,623
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-001	Nov 26, 2002	6,770,623
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-001	Nov 26, 2002	7,351,414
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-002	Jun 25, 2008	7,550,434

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
China	1198644
Spain	2621653
China	1933864	Medication dispensing apparatus with gear set having drive member accommodating opening
European Patent Office	1417972	Solutions stabilisées de Tériparatide (Stabilized teriparatide solutions)
Argentina	033639	USO DE HORMONAS PARATIROIDEAS PARA PREPARAR MEDICAMENTOS PARA REDUCIR EL RIESGO DE FRACTURAS OSEAS VERTEBRALES O NO VERTEBRALES EN SERES HUMANOS CON RIESGO DE PADECER O QUE PADECEN OSTEOPOROSIS
Australia	5575099
Norway	20002945

FORTEO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Forteo

Introduction to Forteo

Forteo, also known as teriparatide, is a synthetic form of the human parathyroid hormone (PTH) approved by the FDA in 2002 for the treatment of osteoporosis in men and postmenopausal women at high risk of fractures. Here, we delve into the market dynamics and financial trajectory of this drug.

Mechanism and Use

Forteo is administered as a daily subcutaneous injection of 20 mcg and is designed to stimulate new bone formation by activating osteoblasts. This mechanism sets it apart from other osteoporosis treatments that primarily focus on preventing bone loss[5].

Market Size and Growth

The global osteoporosis treatment market, within which Forteo operates, is projected to grow significantly. The market size was valued at USD 10.75 billion in 2018 and is expected to reach USD 19.68 billion by 2032, exhibiting a substantial CAGR. The hormone replacement therapy segment, which includes Forteo, is anticipated to exhibit the highest CAGR during this forecast period due to its efficacy and the increasing demand for safe and effective therapeutic options[1].

Sales and Revenue

Forteo has consistently demonstrated strong sales performance. By 2008, Eli Lilly reported $778 million in sales, and by 2018, sales were predicted to reach close to the $2 billion mark. As of July 2023, Forteo had annual sales of $609 million, according to IQVIA data[3][4].

Pricing and Cost Factors

One of the significant factors influencing the financial trajectory of Forteo is its high cost. A one-month supply of Forteo costs approximately $560, which is substantially higher than other osteoporosis treatments such as bisphosphonates, which cost around $67 per month. This high price tag contributes to its exorbitant profits but also poses a financial burden on patients[5].

Insurance and Savings Programs

The cost of Forteo can vary significantly depending on insurance coverage, the quantity prescribed, and the pharmacy used. Patients with insurance may benefit from specific plan benefits and savings programs, but the overall cost remains high. Without insurance, the factors affecting cost include the quantity prescribed and the availability of savings programs[2].

Generic Versions

The approval of generic versions of Forteo, such as the one announced by Teva in November 2023, is expected to impact the market dynamics. Generic drugs typically offer lower costs due to reduced research and development expenses and increased market competition. This could potentially make Forteo more accessible to a wider patient population but may also affect the revenue of the brand-name drug[4].

Safety and Efficacy

Forteo's safety profile is a critical aspect of its market dynamics. While it has been shown to increase bone mineral density and reduce the risk of vertebral fractures in high-risk women, its use is not recommended for more than two years due to limited long-term safety data. It is contraindicated in patients at increased risk of bone cancer and those with certain metabolic bone diseases. Despite these limitations, Forteo remains a valuable option for patients with severe osteoporosis who are intolerant or unresponsive to other treatments[5].

Side Effects and Tolerability

The side effects of Forteo are generally uncommon but can include nausea, dizziness, and leg cramps. Transient hypotension may occur, especially at the start of therapy, but this typically subsides after the first few doses. The tolerability profile, while generally favorable, is another factor that healthcare providers consider when prescribing this drug[5].

Market Competition

The osteoporosis treatment market is competitive, with various drug classes available, including bisphosphonates, SERMs (Selective Estrogen Receptor Modulators), and RANKL inhibitors. The launch of new drugs like Prolia, Evenity, and Arzofiene, which also increase bone mineral density, adds to the competitive landscape. However, Forteo's unique mechanism of stimulating new bone formation helps it maintain a significant market presence[1].

Financial Assistance and Access

Given the high cost of Forteo, financial assistance programs and savings options are crucial for patient access. Manufacturers and pharmacies often offer these programs to help reduce the financial burden on patients. Additionally, the availability of generic versions may further improve access to this treatment[2][4].

Future Outlook

The future of Forteo looks promising, driven by the growing demand for effective osteoporosis treatments and the expanding aging population. The approval of generic versions will likely increase competition but also make the drug more accessible. As research continues to uncover the full potential and safety profile of Forteo, it is expected to remain a key player in the osteoporosis treatment market.

Key Takeaways

• Market Growth: The osteoporosis treatment market is projected to grow significantly, with Forteo expected to exhibit high CAGR.
• Sales and Revenue: Forteo has consistently shown strong sales performance, with annual sales reaching $609 million as of July 2023.
• Pricing: Forteo is one of the more expensive osteoporosis treatments, with a one-month supply costing approximately $560.
• Generic Versions: The approval of generic versions is expected to impact the market dynamics and improve patient access.
• Safety and Efficacy: Forteo increases bone mineral density and reduces vertebral fracture risk but has a limited long-term safety profile.
• Market Competition: Forteo competes with other drug classes but maintains a significant market presence due to its unique mechanism.

FAQs

What is Forteo used for?

Forteo, or teriparatide, is used for the treatment of osteoporosis in men and postmenopausal women who are at high risk of fractures.

How much does Forteo cost?

A one-month supply of Forteo costs approximately $560, which is significantly higher than many other osteoporosis treatments.

Are there generic versions of Forteo available?

Yes, as of November 2023, generic versions of Forteo have been approved, which are expected to offer lower costs and improve patient access.

What are the side effects of Forteo?

Common side effects include nausea, dizziness, and leg cramps. Transient hypotension may also occur, especially at the start of therapy.

Why is Forteo so expensive?

Forteo's high cost is due to the extensive research and development required for its approval and the exclusive patent period during which the manufacturer can sell it without generic competition.

Sources

1. Fortune Business Insights: Osteoporosis Treatment Market Size, Growth, Share | Forecast, 2032
2. Medical News Today: Cost and Forteo: Financial assistance options, savings, more
3. Save Our Bones: The Forteo Mystery: What You Should Know About This Puzzling Drug
4. Teva Pharmaceuticals: Teva Announces Approval of a Generic Version of Forteo (Teriparatide Injection) in the U.S.
5. American Academy of Family Physicians: Teriparatide (Forteo) for Osteoporosis