FORTICAL Drug Patent Profile

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

Fortical is a drug marketed by Upsher Smith Labs and is included in one NDA.

The generic ingredient in FORTICAL is calcitonin salmon recombinant. There are fourteen drug master file entries for this compound. Additional details are available on the calcitonin salmon recombinant profile page.

Summary for FORTICAL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	1
Patent Applications:	293
What excipients (inactive ingredients) are in FORTICAL?	FORTICAL excipients list
DailyMed Link:	FORTICAL at DailyMed

Recent Clinical Trials for FORTICAL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	N/A
Yale University	N/A

See all FORTICAL clinical trials

Paragraph IV (Patent) Challenges for FORTICAL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FORTICAL	Nasal Spray	calcitonin salmon recombinant	200 IU/spray	021406	1	2006-03-29

US Patents and Regulatory Information for FORTICAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Upsher Smith Labs	FORTICAL	calcitonin salmon recombinant	SPRAY, METERED;NASAL	021406-001	Aug 12, 2005		DISCN	No	No

Expired US Patents for FORTICAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upsher Smith Labs	FORTICAL	calcitonin salmon recombinant	SPRAY, METERED;NASAL	021406-001	Aug 12, 2005	6,440,392
Upsher Smith Labs	FORTICAL	calcitonin salmon recombinant	SPRAY, METERED;NASAL	021406-001	Aug 12, 2005	RE40812
Upsher Smith Labs	FORTICAL	calcitonin salmon recombinant	SPRAY, METERED;NASAL	021406-001	Aug 12, 2005	RE43580

International Patents for FORTICAL

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1251867
Australia	783952
Canada	2399505	FORMULATIONS DE CALCITONINE POUR ADMINISTRATION PAR VOIE NASALE (NASAL CALCITONIN FORMULATIONS)
World Intellectual Property Organization (WIPO)	0156594
Australia	3660401
China	1183965
China	1422160

FORTICAL Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Fortical

Introduction

Fortical, a brand name for the drug calcitonin-salmon, is a synthetic version of the hormone calcitonin, which is used to treat osteoporosis. Understanding the market dynamics and financial trajectory of Fortical is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Overview of Osteoporosis Drugs

The osteoporosis drug market is diverse and includes several drug classes such as bisphosphonates, selective estrogen receptor modulators (SERMs), parathyroid hormone (PTH) drugs, and calcitonin drugs. By 2015, the global osteoporosis drug market was expected to reach $16 billion, with the United States and China controlling 61% of the market share[1].

Calcitonin Drugs Market

Calcitonin drugs, including Fortical, play a significant role in the osteoporosis market. Calcitonin works by inhibiting osteoclasts, which are cells responsible for bone resorption, and promoting osteoblasts, which are cells involved in bone formation[4].

Fortical Market Performance

• Historical Sales: Fortical, along with other calcitonin drugs like Miacalcin, has seen fluctuations in market share and sales over the years. In the early 2000s, calcitonin drugs were among the leading treatments for osteoporosis, but their market share has declined with the introduction of newer drugs.
• Forecast: By 2010, the global sales of Miacalcin, another calcitonin drug, were significant, but the forecast indicated a decline in sales due to increased competition from other drug classes like bisphosphonates and PTH drugs[1].

Competitive Landscape

The osteoporosis drug market is highly competitive, with various drug classes vying for market share.

• Bisphosphonates: These drugs, such as Fosamax, Boniva, and Actonel, dominated the market until the early 2010s. However, their market share declined due to patent expirations and the rise of generic alternatives[1].
• PTH Drugs: Forteo, a PTH drug, has been a strong competitor in the market. It is known for its anabolic effects on bone, promoting bone growth rather than just inhibiting bone resorption[1].
• New Entrants: The introduction of drugs like Prolia (denosumab) has significantly altered the market dynamics. Prolia was predicted to lead the market with a nearly 45% share by 2015 due to its efficacy and innovative mechanism of action[1].

Pricing Dynamics

The pricing of Fortical and other osteoporosis drugs is influenced by several factors, including competition, regulatory environment, and patient demand.

• History-Dependent Demand: Studies have shown that patient demand for drugs exhibits history-dependence, meaning that patients tend to stick with familiar drugs rather than switch to new ones. This inertia affects pricing strategies and market shares[3].
• Pharmacy Benefit Managers (PBMs): PBMs play a crucial role in drug pricing by negotiating prices with pharmaceutical companies and influencing formulary decisions. Their involvement can lead to significant cost savings but also affects the profitability of drug companies[3].

Financial Impact of Follow-on Protein Products (FoPPs)

The entry of FoPPs, or biogenerics, into the market can significantly impact the financial trajectory of branded biologics and other drugs.

• Cost Savings: The introduction of FoPPs is estimated to result in substantial cost savings. For example, between 2009 and 2019, FoPPs were expected to save approximately $9.97 billion, with $5.3 billion accruing to private payers and $4.65 billion to public payers[5].
• Market Share and Pricing: FoPPs can lead to price discounts and increased competition, which can reduce the market share and pricing power of branded drugs like Fortical. However, the exact impact depends on factors such as the size of FoPP price discounts and brand price inflation[5].

Distribution Channels

The distribution channels for Fortical and other osteoporosis drugs include hospital pharmacies, retail pharmacies, and online pharmacies.

• Geographical Variations: The prevalence of osteoporosis varies geographically, with higher rates in certain regions like the Middle East and Africa. This can influence the demand for drugs like Fortical in these areas[4].

Future Outlook

The future outlook for Fortical and the broader osteoporosis drug market is shaped by several factors:

• Pipeline Drugs: The launch of new pipeline drugs, such as odanacatib, is expected to further change the market dynamics. These drugs offer new mechanisms of action and potentially better efficacy profiles[1].
• Increasing Awareness and Diagnosis: Growing awareness and improved diagnosis rates for osteoporosis are expected to increase the demand for osteoporosis drugs, including Fortical[1].
• Geriatric Population Growth: The increasing geriatric population, particularly in regions like Asia Pacific, is likely to fuel the growth of the osteoporosis drug market, including calcitonin drugs like Fortical[4].

Key Takeaways

• Market Share: Fortical's market share has declined due to competition from newer drug classes.
• Pricing Dynamics: The pricing of Fortical is influenced by competition, regulatory environment, and patient demand.
• FoPPs Impact: The entry of FoPPs can lead to significant cost savings and altered market dynamics.
• Distribution Channels: Fortical is distributed through hospital pharmacies, retail pharmacies, and online pharmacies.
• Future Outlook: The market is expected to grow due to increasing awareness, improved diagnosis, and a growing geriatric population.

FAQs

1. What is Fortical used for? Fortical is used to treat osteoporosis by inhibiting osteoclasts and promoting osteoblasts, thereby reducing bone resorption and promoting bone formation.

2. How does Fortical compare to other osteoporosis drugs? Fortical is part of the calcitonin drug class, which has seen a decline in market share due to competition from bisphosphonates, PTH drugs, and newer drugs like Prolia.

3. What is the impact of FoPPs on Fortical? The entry of FoPPs can lead to price discounts and increased competition, potentially reducing the market share and pricing power of branded drugs like Fortical.

4. Where is Fortical primarily distributed? Fortical is distributed through hospital pharmacies, retail pharmacies, and online pharmacies.

5. What are the future prospects for Fortical? The future outlook for Fortical is influenced by growing awareness and diagnosis of osteoporosis, as well as the increasing geriatric population, particularly in regions like Asia Pacific.

Sources

1. Renub Research - Global Osteoporosis Market & Drugs Analysis 2010 - 2015
2. ASPE - Economic Analysis of Availability of Follow-on Protein Products
3. Josh Feng - Explaining Prescription Drug Pricing Dynamics
4. Verified Market Research - Calcitonin Salmon Market Size, Trends, Growth, Analysis, Forecast
5. ASPE - Economic Analysis of Availability of Follow-on Protein Products