Teriparatide - Generic Drug Details

What are the generic drug sources for teriparatide and what is the scope of patent protection?

Teriparatide is the generic ingredient in four branded drugs marketed by Alvogen, Lilly, Almaject, Apotex, Teva Pharms Usa, and Sanofi Aventis Us, and is included in six NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

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

Summary for teriparatide

International Patents:	37
US Patents:	1
Tradenames:	4
Applicants:	6
NDAs:	6
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	151
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
Universidad de Valparaiso	Phase 4
Universidade Federal Fluminense	Phase 4
Peking Union Medical College Hospital	N/A

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
Almaject	TERIPARATIDE	teriparatide	SOLUTION;SUBCUTANEOUS	218771-001	Jun 4, 2024		RX	Yes	Yes
Apotex	TERIPARATIDE	teriparatide	SOLUTION;SUBCUTANEOUS	211097-001	Nov 16, 2023	AP	RX	No	No
Alvogen	BONSITY	teriparatide	SOLUTION;SUBCUTANEOUS	211939-001	Oct 4, 2019		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
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 teriparatide

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

International Patents for teriparatide

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1732628	APPAREIL D'ADMINISTRATION DE MEDICAMENT COMPRENANT UN ENSEMBLE ENGRENAGE PRESENTANT UN ORIFICE CONTENANT UN ELEMENT DE COMMANDE (MEDICATION DISPENSING APPARATUS WITH GEAR SET HAVING DRIVE MEMBER ACCOMMODATING OPENING)
Eurasian Patent Organization	200601801	УСТРОЙСТВО ДЛЯ ДОЗИРОВАНИЯ ЛЕКАРСТВЕННЫХ ПРЕПАРАТОВ С ПРУЖИННЫМ БЛОКИРУЮЩИМ УСТРОЙСТВОМ, ПРИВОДИМЫМ В ДЕЙСТВИЕ ПРИ ВВЕДЕНИИ ПОСЛЕДНЕЙ ДОЗЫ
Brazil	PI0509269	aparelho de dispensação de medicamento
Croatia	P20191242

Teriparatide Market Analysis and Financial Projection Experimental

Teriparatide: A Revolutionary Treatment in Osteoporosis Management

Market Overview

The teriparatide market is experiencing significant growth, driven by the increasing prevalence of osteoporosis and advancements in treatment options. Teriparatide, a recombinant version of human parathyroid hormone (PTH), is transforming the management of osteoporosis by promoting bone growth and increasing bone density, unlike other treatments that primarily prevent bone loss[1][4].

Market Size and Projections

The global teriparatide acetate market was valued at USD 100 billion in 2023 and is projected to reach USD 147.75 billion by 2031, growing at a compound annual growth rate (CAGR) of approximately 5% from 2024 to 2031. This growth is attributed to the rising incidence of osteoporosis, advancements in biopharmaceuticals, and increasing healthcare investments[4].

Growth Drivers

Increasing Osteoporosis Prevalence

The global population is aging, and lifestyle changes are contributing to a rise in bone health issues, leading to an increased demand for effective osteoporosis treatments. Teriparatide acetate, with its ability to promote bone growth, is a crucial therapy for individuals at high risk of fractures[1][4].

Advancements in Treatment Options

Recent innovations in teriparatide acetate formulations, such as extended-release products and combination therapies, are enhancing treatment outcomes and improving patient compliance. Ongoing research and clinical trials are exploring new potential uses for teriparatide acetate, including treating bone loss associated with conditions like cancer or steroid-induced osteoporosis[1][4].

Strategic Partnerships and Collaborations

Partnerships between pharmaceutical companies and research institutions are accelerating the development of new teriparatide acetate products and delivery methods. These collaborations also focus on improving patient access and education, which can drive market growth[1].

Clinical Efficacy

Reduction in Fracture Risk

Clinical trials have demonstrated the efficacy of teriparatide in reducing the risk of new vertebral and clinical fractures. For instance, the VERO Study showed that teriparatide reduced the incidence of new vertebral fractures by 56% compared to risedronate after 24 months. Similar reductions were observed in clinical fractures, with a relative risk reduction of 52%[2].

Bone Density Increase

Teriparatide increases bone mineral density (BMD) in both men and women, which is a critical factor in reducing fracture risk. Studies have shown greater increases in BMD with teriparatide compared to bisphosphonates, although the clinical significance of these differences is still being determined[3].

Regulatory and Reimbursement Environment

Approval and Listing

Teriparatide is approved by regulatory bodies such as the Therapeutic Goods Administration (TGA) for treating postmenopausal osteoporosis in women and primary osteoporosis in men. The Pharmaceutical Benefits Advisory Committee (PBAC) has recommended its listing on the basis of acceptable cost-effectiveness compared to other treatments like alendronate[3].

Savings Programs

To make teriparatide more accessible, savings programs are available, allowing eligible patients to pay as little as $0 and receive up to $12,000 off their co-pay or out-of-pocket expenses annually. These programs help in increasing market penetration and patient adherence[5].

Investment Opportunities

Strong Market Demand

The growing demand for effective osteoporosis treatments, coupled with the innovative nature of teriparatide, makes it a promising investment opportunity. The market's strong growth trajectory, driven by increasing osteoporosis prevalence and advancements in treatment options, enhances its investment potential[1][4].

Innovation-Driven Growth

Ongoing research and clinical trials are expanding the therapeutic indications of teriparatide acetate, which could further increase its market potential. Innovations in drug formulations and delivery methods are also expected to drive growth[1].

Supportive Regulatory Environment

Favorable government initiatives and reimbursement policies for osteoporosis treatments support the growth of the teriparatide acetate market. Investors should stay informed about these regulatory developments to capitalize on the market opportunities[4].

Market Segmentation

The teriparatide acetate market is segmented based on type (recombinant parathyroid hormones, osteoporosis treatments, bone-building agents) and application (osteoporosis, bone fractures, bone health). Geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa are also key segments[4].

Key Takeaways

• The teriparatide acetate market is projected to grow significantly due to the increasing prevalence of osteoporosis and advancements in treatment options.
• Teriparatide acetate is unique in its ability to promote bone growth, making it a valuable treatment for severe osteoporosis.
• Clinical trials have demonstrated its efficacy in reducing fracture risk and increasing bone density.
• Strategic partnerships, innovations in formulations, and favorable regulatory environments are driving market growth.
• Investment opportunities are enhanced by strong market demand, innovation-driven growth, and a supportive regulatory environment.

FAQs

What is the primary mechanism of action of teriparatide acetate?

Teriparatide acetate works by stimulating osteoblast activity, leading to increased bone formation and density, unlike other osteoporosis treatments that primarily prevent bone loss[1].

How does teriparatide acetate reduce fracture risk?

Clinical trials have shown that teriparatide acetate reduces the risk of new vertebral and clinical fractures by up to 56% compared to other treatments like risedronate[2].

What are the key drivers of the teriparatide acetate market growth?

The market growth is driven by increasing osteoporosis prevalence, advancements in treatment options, innovations in drug formulations, and favorable regulatory and reimbursement environments[1][4].

Is teriparatide acetate approved for use in men?

Yes, teriparatide acetate is approved for treating primary osteoporosis in men, particularly those with hypogonadal or idiopathic osteoporosis[3].

Are there savings programs available for teriparatide acetate?

Yes, eligible patients can benefit from savings programs that offer significant reductions in co-pay or out-of-pocket expenses, making the treatment more accessible[5].

Sources

1. Market Research Intellect: "Teriparatide Acetate Market Expansion, Breakthroughs, and Trends in Osteoporosis Treatment"[1].
2. Eli Lilly and Company: "New Data on FORTEO® (teriparatide [rDNA origin] injection) Showed Reduced Risk for New Vertebral and Clinical Fractures in Postmenopausal Women with Severe Osteoporosis"[2].
3. NPS MedicineWise: "Teriparatide (Forteo) for severe osteoporosis"[3].
4. Market Research Intellect: "Teriparatide Acetate Market Size and Projections"[4].
5. Alvogen: "Savings Program - Alvogen Teriparatide"[5].