PARICALCITOL - Generic Drug Details

What are the generic sources for paricalcitol and what is the scope of freedom to operate?

Paricalcitol is the generic ingredient in two branded drugs marketed by Amneal Pharms, Aurobindo Pharma Ltd, Bionpharma, Dr Reddys, Lotus Pharm Co Ltd, Marksans Pharma, Rising, Teva Pharms Usa, Abbvie, Accord Hlthcare, Amneal Pharms Co, Epic Pharma Llc, Eugia Pharma, Hikma Pharms, Hospira, and Sandoz, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for paricalcitol. Twelve suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for PARICALCITOL

US Patents:	0
Tradenames:	2
Applicants:	16
NDAs:	19
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	96
Patent Applications:	2,797
Drug Prices:	Drug price trends for PARICALCITOL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PARICALCITOL
What excipients (inactive ingredients) are in PARICALCITOL?	PARICALCITOL excipients list
DailyMed Link:	PARICALCITOL at DailyMed

See drug prices for PARICALCITOL

See drug sales revenues for PARICALCITOL

Recent Clinical Trials for PARICALCITOL

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

Sponsor	Phase
Cedars-Sinai Medical Center	Early Phase 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Early Phase 1
Chengdu Suncadia Medicine Co., Ltd.	Phase 3

See all PARICALCITOL clinical trials

Generic filers with tentative approvals for PARICALCITOL

Applicant	Application No.	Strength	Dosage Form
		2MCG/ML	INJECTABLE; INJECTION
		10MCG/ML	INJECTABLE; INJECTION
		5MCG/ML	INJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for PARICALCITOL

Drug Class

Vitamin D Analog Vitamin D2 Analog Vitamin D3 Analog

Anatomical Therapeutic Chemical (ATC) Classes for PARICALCITOL

H05BX	Other anti-parathyroid agents
H05B	ANTI-PARATHYROID AGENTS
H05	CALCIUM HOMEOSTASIS
H	Systemic hormonal preparations, excluding sex hormones and insulins

Paragraph IV (Patent) Challenges for PARICALCITOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZEMPLAR	Injection	paricalcitol	0.002 mg per mL in 1 mL vial and 0.005 mg per mL in 1 mL and 2 mL vials	020819	1	2008-11-28
ZEMPLAR	Capsules	paricalcitol	1 mcg and 2 mcg	021606	1	2008-10-14
ZEMPLAR	Capsules	paricalcitol	4 mcg	021606	1	2008-08-25

US Patents and Regulatory Information for PARICALCITOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lotus Pharm Co Ltd	PARICALCITOL	paricalcitol	CAPSULE;ORAL	206710-003	Feb 24, 2016		DISCN	No	No
Lotus Pharm Co Ltd	PARICALCITOL	paricalcitol	CAPSULE;ORAL	206710-002	Feb 24, 2016		DISCN	No	No
Aurobindo Pharma Ltd	PARICALCITOL	paricalcitol	CAPSULE;ORAL	207672-001	Jan 14, 2016	AB	RX	No	No
Rising	PARICALCITOL	paricalcitol	CAPSULE;ORAL	202124-003	Jun 24, 2014	AB	RX	No	No
Lotus Pharm Co Ltd	PARICALCITOL	paricalcitol	CAPSULE;ORAL	206710-001	Feb 24, 2016		DISCN	No	No
Hikma Pharms	PARICALCITOL	paricalcitol	SOLUTION;INTRAVENOUS	205917-002	Nov 18, 2014	AP	RX	No	No
Abbvie	ZEMPLAR	paricalcitol	CAPSULE;ORAL	021606-002	May 26, 2005	AB	RX	Yes	No

Expired US Patents for PARICALCITOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ZEMPLAR	paricalcitol	SOLUTION;INTRAVENOUS	020819-002	Feb 1, 2000	5,246,925*PED
Abbvie	ZEMPLAR	paricalcitol	SOLUTION;INTRAVENOUS	020819-001	Apr 17, 1998	5,597,815*PED
Abbvie	ZEMPLAR	paricalcitol	SOLUTION;INTRAVENOUS	020819-003	Feb 1, 2000	6,361,758*PED
Abbvie	ZEMPLAR	paricalcitol	SOLUTION;INTRAVENOUS	020819-002	Feb 1, 2000	6,361,758*PED
Abbvie	ZEMPLAR	paricalcitol	CAPSULE;ORAL	021606-002	May 26, 2005	5,587,497*PED
Abbvie	ZEMPLAR	paricalcitol	CAPSULE;ORAL	021606-003	May 26, 2005	5,597,815*PED
Abbvie	ZEMPLAR	paricalcitol	CAPSULE;ORAL	021606-001	May 26, 2005	5,246,925*PED

PARICALCITOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Paricalcitol

Introduction

Paricalcitol, a synthetic vitamin D2 analog, is widely used in the treatment of secondary hyperparathyroidism (SHPT), a common complication of chronic kidney disease (CKD). This article delves into the market dynamics and financial trajectory of paricalcitol, highlighting its clinical benefits, cost-effectiveness, and market projections.

Clinical Benefits of Paricalcitol

Paricalcitol is preferred over traditional vitamin D analogs like calcitriol due to its faster suppression of parathyroid hormone (PTH) with minimal impact on calcium and phosphorus levels. This reduces the risk of hypercalcemia and hyperphosphatemia, making it a more effective treatment for SHPT[1][2][5].

Cost-Effectiveness Analysis

Several studies have demonstrated the cost-effectiveness of paricalcitol compared to other treatments.

• In Brazil, a cost-effectiveness analysis showed that paricalcitol generated 16.28 life years (LY) gained versus 14.11 LY gained with calcitriol, with an incremental cost-effectiveness ratio of BRL 7,740 per LY gained. This indicates that paricalcitol is cost-effective from the public healthcare system perspective[1].
• A German study found that intravenous paricalcitol had a clear advantage in terms of costs, effectiveness, and utilities compared to oral calcitriol and intravenous alfacalcidol. The analysis confirmed the first-order dominance of intravenous paricalcitol for a wide range of hospitalization costs[2].
• In the UK, paricalcitol was found to be cost-effective versus non-selective vitamin D receptor activators, with an incremental cost-effectiveness ratio of £6,933 per quality-adjusted life year (QALY) gained[3].

Market Size and Projections

The market for paricalcitol is growing steadily due to its clinical and economic benefits.

• As of 2023, the paricalcitol market size was valued at USD 1.4 billion. It is expected to reach USD 2.4 billion by 2031, growing at a compound annual growth rate (CAGR) of 7% from 2024 to 2031[4].

Key Drivers of Market Growth

Several factors are driving the growth of the paricalcitol market:

• Increasing Prevalence of CKD: The rising incidence of chronic kidney disease globally is a significant driver, as SHPT is a common complication of CKD.
• Clinical Efficacy: Paricalcitol's superior clinical outcomes, including faster PTH suppression and reduced risk of hypercalcemia and hyperphosphatemia, make it a preferred treatment option.
• Cost-Effectiveness: The drug's cost-effectiveness, as demonstrated in various studies, makes it an attractive option for healthcare systems looking to manage costs while improving patient outcomes.
• Regulatory Approvals: Continued regulatory approvals and recommendations from health organizations further support the market growth of paricalcitol.

Market Challenges

Despite the positive market dynamics, there are challenges to consider:

• Competition from Generic Alternatives: The potential entry of generic versions of paricalcitol could impact market share and pricing.
• Side Effects and Monitoring: While paricalcitol has a favorable safety profile, monitoring for potential side effects such as hypercalcemia is necessary, which can add to the overall cost of treatment.
• Regional Healthcare Policies: The cost-effectiveness and reimbursement policies can vary significantly across different regions, affecting market penetration.

Financial Trajectory

The financial trajectory of paricalcitol is promising due to its growing market size and increasing adoption.

• Revenue Growth: The projected growth from USD 1.4 billion in 2023 to USD 2.4 billion by 2031 indicates a robust financial trajectory.
• Investment and Research: Continued investment in research and development to enhance the drug's efficacy and expand its indications will further support its financial growth.
• Global Expansion: Expanding into new markets, particularly in regions with high prevalence of CKD, will be crucial for sustaining the financial growth of paricalcitol.

Conclusion

Paricalcitol's market dynamics are driven by its clinical efficacy, cost-effectiveness, and growing demand due to the increasing prevalence of CKD. While there are challenges to navigate, the overall financial trajectory of paricalcitol is positive, with significant growth projected in the coming years.

Key Takeaways

• Paricalcitol offers superior clinical benefits over traditional vitamin D analogs.
• It is cost-effective in various healthcare settings, including Brazil, Germany, and the UK.
• The market size is expected to grow from USD 1.4 billion in 2023 to USD 2.4 billion by 2031.
• Key drivers include the increasing prevalence of CKD, clinical efficacy, and cost-effectiveness.
• Challenges such as competition from generics and regional healthcare policies need to be addressed.

FAQs

Q: What is paricalcitol used for?

Paricalcitol is used for the treatment of secondary hyperparathyroidism (SHPT), a common complication of chronic kidney disease (CKD).

Q: How does paricalcitol compare to calcitriol in terms of cost-effectiveness?

Paricalcitol is generally more cost-effective than calcitriol, generating more life years gained with lower incremental costs per life year saved in various studies[1][2].

Q: What is the projected market size of paricalcitol by 2031?

The paricalcitol market is expected to reach USD 2.4 billion by 2031, growing at a CAGR of 7% from 2024 to 2031[4].

Q: What are the key drivers of the paricalcitol market growth?

Key drivers include the increasing prevalence of CKD, the clinical efficacy of paricalcitol, its cost-effectiveness, and regulatory approvals.

Q: What challenges might affect the market growth of paricalcitol?

Challenges include competition from generic alternatives, potential side effects requiring monitoring, and varying regional healthcare policies.

Sources

1. Cost-effectiveness analysis of paricalcitol versus calcitriol for the treatment of secondary hyperparathyroidism in patients on dialysis. PubMed.
2. Health-economic comparison of paricalcitol, calcitriol and alfacalcidol for the treatment of patients with secondary hyperparathyroidism. PubMed.
3. Cost Effectiveness of Paricalcitol versus a non-selective vitamin D receptor activator for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease. PubMed.
4. Paricalcitol Market Size and Projections. Market Research Intellect.
5. Treatment of secondary hyperparathyroidism in non-dialysis CKD. Oxford Academic.