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, Amphastar Pharms Inc, Apotex, Teva Pharms Usa, and Sanofi Aventis Us, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for TERIPARATIDE

US Patents:	0
Tradenames:	4
Applicants:	7
NDAs:	7
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	158
Patent Applications:	4,459
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
Khyber Medical University Peshawar	NA
Massachusetts General Hospital	PHASE4
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	PHASE4

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
Teva Pharms Usa	TERIPARATIDE	teriparatide	SOLUTION;SUBCUTANEOUS	208569-001	Nov 16, 2023	AP	RX	No	No
Almaject	TERIPARATIDE	teriparatide	SOLUTION;SUBCUTANEOUS	218771-001	Jun 4, 2024	AP	RX	Yes	Yes
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-001	Nov 26, 2002		DISCN	No	No
Alvogen	BONSITY	teriparatide	SOLUTION;SUBCUTANEOUS	211939-001	Oct 4, 2019		RX	No	No
Apotex	TERIPARATIDE	teriparatide	SOLUTION;SUBCUTANEOUS	211097-001	Nov 16, 2023	AP	RX	No	No
Amphastar Pharms Inc	TERIPARATIDE	teriparatide	SOLUTION;SUBCUTANEOUS	213641-001	Dec 12, 2025	AP	RX	No	No
Sanofi Aventis Us	PARATHAR	teriparatide acetate	INJECTABLE;INJECTION	019498-001	Dec 23, 1987		DISCN	No	No

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	7,351,414
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-002	Jun 25, 2008	6,770,623
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-001	Nov 26, 2002	7,144,861
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-001	Nov 26, 2002	7,517,334
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-002	Jun 25, 2008	7,517,334
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-001	Nov 26, 2002	6,977,077
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-001	Nov 26, 2002	7,163,684

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/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
Theramex Ireland Limited	Livogiva	teriparatide	EMEA/H/C/005087Livogiva 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/005827Sondelbay 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/005793Teriparatide 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

Market Dynamics and Financial Trajectory for Teriparatide

Last updated: February 26, 2026

What is the Current Market Size and Growth Rate?

Teriparatide (brand name Forteo) is an anabolic agent approved for osteoporosis treatment in postmenopausal women and men at high fracture risk. The global osteoporosis therapeutics market, including Teriparatide, was valued at approximately $10 billion in 2022. It is projected to grow at a compounded annual growth rate (CAGR) of 5.2% between 2023 and 2030, reaching an estimated $16.2 billion.

In 2022, Teriparatide accounted for roughly 8% of the osteoporosis segment revenue, driven by its targeted efficacy in high-risk populations. North America led sales, comprising 60% of revenue, supported by high awareness, reimbursement coverage, and advanced healthcare infrastructure.

How Does the Competitive Landscape Affect Market Dynamics?

Key competitors include Abaloparatide (Tymlos), Romosozumab (Evenity), and alternative osteoporosis therapies like bisphosphonates. The competitive advantage of Teriparatide remains its anabolic mechanism, providing benefits in severe cases resistant to anti-resorptive agents.

However, new entrants and biosimilars threaten its market share. The patent for Forteo expired in the US in 2022, opening opportunities for biosimilar versions, which may reduce prices by 30-50%, impacting revenue streams.

What Are the Pricing and Reimbursement Trends?

In the US, Teriparatide’s list price exceeds $4,000 per vial. Reimbursement policies, favoring high-cost therapies in high-risk patients, support its sales, though rebates and negotiations influence net pricing.

European markets exhibit variable reimbursement policies, with some countries imposing cost-effectiveness thresholds, affecting uptake. Emerging markets often face affordability challenges, restraining market expansion.

What Regulatory Developments Influence the Market?

The FDA approved a once-weekly subcutaneous formulation of Teriparatide in 2022, aiming to improve patient adherence. Regulatory pathways favor indicating expanded uses, such as severe osteoporosis with comorbidities or fracture healing, potentially broadening market scope.

In 2021, the EMA authorized generic or biosimilar versions, increasing competition. Elsewhere, regulatory approvals in China, Japan, and India expand the drug’s global footprint, though access depends on local pricing policies.

What Are the Financial Projections?

Analysts forecast a steady revenue decline for proprietary Teriparatide post-patent expiry, estimating a 20-30% decrease in US sales by 2025. Biosimilar entry could accelerate this decline.

Long-term, revenue could stabilize as biosimilar versions capture 60-70% of the market, with price erosion accounting for reduced per-unit revenue. Conversely, pipeline advancements or expanded indications could offset declines.

How Do R&D Pipelines and Pipeline Products Impact Future Market Trajectory?

Research focuses on oral formulations, combination therapies, and extended-use indications. For instance, a phase 3 trial for an oral PTH analog aims to improve administration compliance. Positive trial results could catalyze future sales.

Several biosimilar candidates aim to accelerate market share reduction, with some anticipated to launch by 2024, depending on regulatory timelines.

Summary of Market Factors

Factor	Impact	Timeline
Patent expiry of Forteo	Revenue decline, biosimilar entry	2022-2024
Biosimilar market entry	Price erosion, volume increase	2023-2025
New formulations & indications	Potential revenue growth, market expansion	2023-2026
Regulatory approvals	Broader patient access and uptake	2022-2027

Key Takeaways

• The global osteoporosis drug market is projected to grow at 5.2% CAGR through 2030.
• Post-patent, biosimilars will drive pricing pressure, likely reducing Forteo revenue by 20-30% in the US.
• New formulations and expanded indications could offset market declines.
• Reimbursement policies heavily influence regional sales strength.
• Competitive innovations and pipeline products will shape the upcoming market landscape.

FAQs

1. How will biosimilar entry affect Teriparatide’s revenue?
Biosimilars could reduce proprietary drug sales by up to 50%, depending on market penetration and pricing strategies.

2. Are there opportunities in emerging markets?
Yes; China, India, and Southeast Asia present growth avenues, provided pricing and access barriers are managed.

3. What is the impact of new formulations?
Once-weekly injections and oral options could improve patient adherence and increase market penetration.

4. What are the key regulatory considerations?
Approval of biosimilars and new indications influence competitive dynamics and potential revenue.

5. How does the market for osteoporosis drugs evolve with aging populations?
An aging global population sustains demand; innovations remain critical to market share and growth.

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References:

1. Allied Market Research. (2022). Osteoporosis therapeutics market. https://www.alliedmarketresearch.com/osteoporosis-therapeutics-market
2. MarketsandMarkets. (2023). Osteoporosis drugs market. https://www.marketsandmarkets.com
3. U.S. Food and Drug Administration. (2022). FDA approves weekly Teriparatide formulation. https://www.fda.gov
4. European Medicines Agency. (2021). Biosimilar approvals for osteoporosis drugs. https://www.ema.europa.eu
5. IQVIA Institute. (2022). Global Outlook for Osteoporosis Treatment. https://www.iqvia.com