LOZOL Drug Patent Profile

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

Lozol is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in LOZOL is indapamide. There are seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the indapamide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lozol

A generic version of LOZOL was approved as indapamide by ANI PHARMS on July 27^th, 1995.

Summary for LOZOL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	114
Patent Applications:	4,578
DailyMed Link:	LOZOL at DailyMed

US Patents and Regulatory Information for LOZOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	LOZOL	indapamide	TABLET;ORAL	018538-002	Apr 29, 1993		DISCN	Yes	No
Sanofi Aventis Us	LOZOL	indapamide	TABLET;ORAL	018538-001	Jul 6, 1983		DISCN	Yes	No

Expired US Patents for LOZOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	LOZOL	indapamide	TABLET;ORAL	018538-001	Jul 6, 1983	3,565,911

International Patents for LOZOL

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

Country	Patent Number	Title	Estimated Expiration
Sweden	334887
Denmark	126193
Norway	128068
Spain	364421
Belgium	728658

LOZOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lozol (Indapamide)

Introduction to Lozol

Lozol, also known as indapamide, is an oral antihypertensive/diuretic used primarily for the treatment of hypertension and fluid retention associated with congestive heart failure. It is chemically distinct from thiazides, lacking the thiazide ring system and containing only one sulfonamide group[2][4].

Market Indications and Usage

Lozol is indicated for the treatment of hypertension, either alone or in combination with other antihypertensive drugs. It is also used to manage salt and fluid retention in patients with congestive heart failure. This dual indication positions Lozol in a significant market segment within the cardiovascular disease treatment landscape[2][4].

Competitive Landscape

The market for antihypertensive and diuretic drugs is highly competitive, with various classes of drugs available, including thiazides, ACE inhibitors, beta-blockers, and calcium channel blockers. Lozol's unique chemical structure and mechanism of action set it apart, but it must compete with other established and newer drugs in the market.

Financial Performance and Market Size

While specific financial data for Lozol alone is not readily available, the broader market for antihypertensive drugs provides context. The global market for cardiovascular drugs, which includes antihypertensives, is substantial and growing. For instance, the lipid-lowering drugs market, a related segment, was valued at USD 33.12 billion in 2023 and is expected to reach USD 46.58 billion by 2033, growing at a CAGR of 3.47%[3].

Regional Market Dynamics

• North America: This region leads the market for cardiovascular drugs due to a high prevalence of cardiovascular diseases and a well-developed healthcare infrastructure. The sedentary lifestyle and higher demand for cardiovascular treatments contribute to the market's growth[3].
• Asia-Pacific: This region is expected to witness the fastest growth due to an increasing geriatric population and rising adoption of sedentary lifestyles, leading to higher cholesterol levels and cardiovascular diseases[3].

Distribution Channels

The distribution of Lozol, like other pharmaceuticals, occurs through various channels including retail pharmacies, hospital pharmacies, and online pharmacies. Online pharmacies are seeing significant growth due to their convenience, especially for patients with mobility issues or busy schedules[3].

Pricing and Reimbursement

The pricing of Lozol can vary based on the region, insurance coverage, and government reimbursement policies. In general, diuretics like Lozol are often priced lower than newer classes of antihypertensive drugs, making them more accessible to a broader patient population.

Side Effects and Safety Profile

While Lozol is generally well-tolerated, it has a range of potential side effects, including mild and transient adverse reactions such as headache, dizziness, and gastrointestinal disturbances. More severe but rare reactions include jaundice, hepatitis, pancreatitis, and abnormal liver function tests, which are reversible upon discontinuation of the drug[1][2][4].

Clinical Trials and Efficacy

Lozol has been studied in several clinical trials, demonstrating its efficacy in reducing blood pressure and managing fluid retention. It has shown additive effects when used in combination with other antihypertensive drugs, making it a versatile treatment option[2][4].

Regulatory Environment

Lozol is approved by regulatory bodies such as the FDA and is subject to ongoing monitoring for safety and efficacy. The regulatory environment can impact the market dynamics through approvals, warnings, and changes in labeling[2][4].

Future Outlook

Given the increasing prevalence of cardiovascular diseases globally, the demand for antihypertensive and diuretic drugs like Lozol is expected to remain strong. Advances in healthcare infrastructure, especially in emerging markets, and the convenience offered by online pharmacies will continue to drive the market growth.

Key Takeaways

• Market Indications: Lozol is used for hypertension and fluid retention in congestive heart failure.
• Competitive Landscape: Highly competitive market with various classes of antihypertensive drugs.
• Financial Performance: Part of a large and growing cardiovascular drug market.
• Regional Dynamics: North America leads, with Asia-Pacific showing rapid growth.
• Distribution Channels: Retail, hospital, and online pharmacies.
• Safety Profile: Generally well-tolerated with rare but reversible severe side effects.
• Future Outlook: Strong demand due to increasing cardiovascular diseases.

Frequently Asked Questions (FAQs)

Q: What is Lozol used for? A: Lozol (indapamide) is used to treat hypertension and fluid retention associated with congestive heart failure.

Q: How does Lozol differ from other diuretics? A: Lozol does not possess the thiazide ring system and contains only one sulfonamide group, distinguishing it from thiazide diuretics.

Q: What are the common side effects of Lozol? A: Common side effects include headache, dizziness, and gastrointestinal disturbances. Rare but severe side effects include jaundice, hepatitis, and pancreatitis.

Q: Can Lozol be used in combination with other antihypertensive drugs? A: Yes, Lozol can be used in combination with other antihypertensive drugs and has shown additive effects in clinical trials.

Q: What is the expected market growth for cardiovascular drugs like Lozol? A: The market for cardiovascular drugs, including antihypertensives, is expected to grow significantly, driven by the increasing prevalence of cardiovascular diseases globally.

Cited Sources:

1. RxList: Lozol (Indapamide): Side Effects, Uses, Dosage...
2. FDA Label: Lozol Label - accessdata.fda.gov
3. Precedence Research: Lipid-lowering Drugs Market Size to Hit USD 46.58 Bn by 2033
4. FDA Label: Lozol® - accessdata.fda.gov