ZEMPLAR Drug Patent Profile

When do Zemplar patents expire, and what generic alternatives are available?

Zemplar is a drug marketed by Abbvie and is included in two NDAs.

The generic ingredient in ZEMPLAR is paricalcitol. There are ten drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the paricalcitol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zemplar

A generic version of ZEMPLAR was approved as paricalcitol by SANDOZ on July 27^th, 2011.

Summary for ZEMPLAR

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	63
Patent Applications:	1,843
Drug Prices:	Drug price information for ZEMPLAR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZEMPLAR
What excipients (inactive ingredients) are in ZEMPLAR?	ZEMPLAR excipients list
DailyMed Link:	ZEMPLAR at DailyMed

See drug prices for ZEMPLAR

See drug sales revenues for ZEMPLAR

Recent Clinical Trials for ZEMPLAR

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

Sponsor	Phase
Emory University	Phase 2
Washington University School of Medicine	Phase 1
Ipsen	Phase 1

See all ZEMPLAR clinical trials

Pharmacology for ZEMPLAR

Drug Class

Vitamin D Analog Vitamin D2 Analog

Paragraph IV (Patent) Challenges for ZEMPLAR

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 ZEMPLAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	ZEMPLAR	paricalcitol	CAPSULE;ORAL	021606-001	May 26, 2005	AB	RX	Yes	No
Abbvie	ZEMPLAR	paricalcitol	SOLUTION;INTRAVENOUS	020819-002	Feb 1, 2000	AP	RX	Yes	Yes
Abbvie	ZEMPLAR	paricalcitol	CAPSULE;ORAL	021606-002	May 26, 2005	AB	RX	Yes	No
Abbvie	ZEMPLAR	paricalcitol	CAPSULE;ORAL	021606-003	May 26, 2005		DISCN	Yes	No

Expired US Patents for ZEMPLAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ZEMPLAR	paricalcitol	SOLUTION;INTRAVENOUS	020819-002	Feb 1, 2000
Abbvie	ZEMPLAR	paricalcitol	SOLUTION;INTRAVENOUS	020819-001	Apr 17, 1998
Abbvie	ZEMPLAR	paricalcitol	SOLUTION;INTRAVENOUS	020819-003	Feb 1, 2000
Abbvie	ZEMPLAR	paricalcitol	SOLUTION;INTRAVENOUS	020819-002	Feb 1, 2000

International Patents for ZEMPLAR

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

Country	Patent Number	Title	Estimated Expiration
Japan	2011037860	COSOLVENT FORMULATION
Denmark	0837681
Germany	69634483
World Intellectual Property Organization (WIPO)	9702826

Supplementary Protection Certificates for ZEMPLAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0387077	SPC/GB04/003	United Kingdom		PRODUCT NAME: PARICALCITOL; REGISTERED: ES SPAIN 64.974 20020809; UK PL 00037/0403 20030721

ZEMPLAR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zemplar

Introduction

Zemplar, marketed by Abbott Laboratories (now part of AbbVie), is a vitamin D analog used for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease. Here, we will delve into the market dynamics and financial trajectory of this drug.

Medical Uses and Market Position

Zemplar is specifically indicated for adults and pediatric patients 10 years and older for the management of secondary hyperparathyroidism, a condition common in patients with chronic kidney disease (CKD)[4].

Competitive Landscape

In the treatment of secondary hyperparathyroidism, Zemplar competes with other vitamin D derivatives such as calcitriol and alfacalcidol. However, studies have shown that intravenous paricalcitol (Zemplar) has a cost and effectiveness advantage over these competitors, particularly in terms of hospitalization costs and patient utilities[3].

Financial Performance

Revenue Contribution

Zemplar has been a significant contributor to AbbVie's revenue. In the third quarter of 2013, for example, Zemplar was highlighted as one of the products driving strong sales growth for AbbVie, alongside other key products like HUMIRA, Synthroid, Creon, and Duodopa[5].

Sales Growth

The sales of Zemplar have shown steady growth, contributing to the overall revenue increase of AbbVie. In the third quarter of 2013, AbbVie reported a 3.3% increase in worldwide sales, with Zemplar being one of the products contributing to this growth despite challenges such as the loss of exclusivity for other products like TriCor/Trilipix[5].

Operational Impact

The operational performance of Zemplar is reflected in AbbVie's financial reports. For instance, in the second and third quarters of 2013, AbbVie's revenue growth was driven by the strength of its key products, including Zemplar. This growth was achieved despite unfavorable foreign exchange rate fluctuations and the loss of exclusivity for certain other products[2][5].

Health-Economic Impact

Cost-Effectiveness

Studies have demonstrated that Zemplar is cost-effective compared to other treatments for secondary hyperparathyroidism. A health-economic comparison showed that intravenous paricalcitol had a clear advantage in terms of costs, effectiveness, and patient utilities when compared to oral calcitriol or intravenous alfacalcidol[3].

Hospitalization Costs

The cost sensitivity analysis performed in one study indicated that intravenous paricalcitol exhibited first-order dominance over other treatments for a wide range of hospitalization costs associated with kidney disease and dialysis[3].

Clinical Trials and Safety Profile

Clinical Studies

The safety and efficacy of Zemplar have been evaluated in several clinical studies. For example, in CKD Stages 3 and 4 patients, Zemplar capsules were found to be generally well-tolerated, with adverse events such as nausea, conjunctivitis, and rhinitis occurring at a frequency of 2% or greater and more frequently than in the placebo group[4].

Adverse Reactions

Common adverse reactions associated with Zemplar include gastrointestinal disorders like nausea and abdominal pain, metabolic disorders such as hypercalcemia and hyperphosphatemia, and nervous system disorders like headache. These reactions highlight the need for careful dose adjustment and monitoring[4].

Market Trends and Future Outlook

Growing Demand

The demand for treatments of secondary hyperparathyroidism is expected to grow due to the increasing prevalence of chronic kidney disease. As a result, Zemplar is likely to continue playing a significant role in this therapeutic area.

Competitive Pressure

While Zemplar has a strong market position, it faces competition from other vitamin D analogs. Continuous innovation and clinical evidence supporting its efficacy and cost-effectiveness will be crucial in maintaining its market share.

Key Takeaways

• Market Position: Zemplar is a leading treatment for secondary hyperparathyroidism associated with chronic kidney disease.
• Financial Performance: Zemplar contributes significantly to AbbVie's revenue, showing steady growth despite market challenges.
• Health-Economic Impact: Zemplar is cost-effective and offers better patient utilities compared to other treatments.
• Clinical Safety: Zemplar is generally well-tolerated, but requires careful dose adjustment to manage adverse reactions.
• Future Outlook: The growing demand for CKD treatments and continuous innovation will be key to Zemplar's future success.

FAQs

What is Zemplar used for?

Zemplar is used for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease.

Who manufactures Zemplar?

Zemplar is manufactured by Abbott Laboratories, now part of AbbVie.

How is Zemplar administered?

Zemplar can be administered orally or intravenously[1].

What are the common adverse reactions associated with Zemplar?

Common adverse reactions include gastrointestinal disorders, metabolic disorders like hypercalcemia and hyperphosphatemia, and nervous system disorders like headache[4].

Is Zemplar cost-effective compared to other treatments?

Yes, studies have shown that intravenous paricalcitol (Zemplar) is cost-effective and offers better patient utilities compared to other treatments for secondary hyperparathyroidism[3].

Sources

1. Wikipedia: Paricalcitol
2. AbbVie: AbbVie Reports Second-Quarter 2013 Financial Results
3. PubMed: Health-economic comparison of paricalcitol, calcitriol and alfacalcidol
4. Drugs.com: Zemplar: Package Insert / Prescribing Information
5. AbbVie: AbbVie Reports Third-Quarter 2013 Financial Results