Suppliers and packagers for generic pharmaceutical drug: PITAVASTATIN MAGNESIUM

PITAVASTATIN MAGNESIUM

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Medicure	ZYPITAMAG	pitavastatin magnesium	TABLET;ORAL	208379	NDA	Medicure International Inc	25208-201-09	90 TABLET, FILM COATED in 1 BOTTLE (25208-201-09)	2018-03-09
Medicure	ZYPITAMAG	pitavastatin magnesium	TABLET;ORAL	208379	NDA	Medicure International Inc	25208-201-15	500 TABLET, FILM COATED in 1 BOTTLE (25208-201-15)	2018-03-09
Medicure	ZYPITAMAG	pitavastatin magnesium	TABLET;ORAL	208379	NDA	Medicure International Inc	25208-202-09	90 TABLET, FILM COATED in 1 BOTTLE (25208-202-09)	2018-03-09
Medicure	ZYPITAMAG	pitavastatin magnesium	TABLET;ORAL	208379	NDA	Medicure International Inc	25208-202-15	500 TABLET, FILM COATED in 1 BOTTLE (25208-202-15)	2018-03-09

Pitavastatin Magnesium: Key Suppliers and Patent Landscape

Last updated: February 19, 2026

This report details the primary suppliers of pitavastatin magnesium, a cholesterol-lowering medication, and analyzes the relevant patent landscape impacting its market. The analysis focuses on key manufacturers, their production capacities, and the expiration timelines of critical intellectual property.

Who Are the Leading Suppliers of Pitavastatin Magnesium?

The global supply of pitavastatin magnesium is dominated by a limited number of active pharmaceutical ingredient (API) manufacturers, primarily located in Asia. These companies possess the necessary regulatory approvals and production scale to meet international demand.

• Shimano Pharmaceutical Co., Ltd. is a significant producer of pitavastatin magnesium. The company operates manufacturing facilities in Japan and has a history of supplying the active ingredient to global pharmaceutical markets. Their production is characterized by adherence to stringent Good Manufacturing Practice (GMP) standards.

• Zhejiang Medicines & Health Products Import & Export Co., Ltd. (ZMC), a Chinese pharmaceutical group, is another major supplier. ZMC's operations include large-scale API manufacturing, and they are known for their competitive pricing and substantial output of various pharmaceutical intermediates and APIs, including statins.

• Vivimed Labs Limited, an India-based pharmaceutical company, also supplies pitavastatin magnesium. Vivimed has a diversified portfolio of APIs and intermediates, and its pitavastatin magnesium production is geared towards both domestic and international markets. The company emphasizes its regulatory compliance and quality control processes.

• Hunan Huacheng Biotech, Inc., another Chinese entity, is involved in the production of pharmaceutical ingredients. Their involvement in pitavastatin magnesium supply is part of a broader offering of chemical synthesis products.

• Unichem Laboratories Ltd., an Indian pharmaceutical company, contributes to the supply chain, particularly for markets requiring regulatory filings in regions like the United States and Europe. Unichem has multiple manufacturing sites and a strong focus on quality assurance.

What is the Production Capacity and Regulatory Status of Key Suppliers?

Production capacities for pitavastatin magnesium API are not publicly disclosed by most manufacturers due to competitive reasons. However, industry estimates suggest that leading suppliers can produce metric tons of the API annually to meet global demand. Regulatory compliance is a critical factor, with suppliers requiring approvals from bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan for their products to be used in regulated markets.

• Shimano Pharmaceutical Co., Ltd. holds certifications including GMP and ISO. Their facilities are regularly inspected by international regulatory authorities.

• Zhejiang Medicines & Health Products Import & Export Co., Ltd. (ZMC) has obtained DMF (Drug Master File) submissions in various regions, indicating compliance with regulatory requirements for API production.

• Vivimed Labs Limited has successfully undergone inspections from regulatory agencies including the US FDA and is a registered supplier for many multinational pharmaceutical companies.

• Unichem Laboratories Ltd. operates multiple WHO-GMP certified facilities and has a significant number of US FDA-approved ANDAs (Abbreviated New Drug Applications) for its finished dosage forms, which relies on its own API production capabilities.

What is the Patent Landscape for Pitavastatin Magnesium?

The patent landscape for pitavastatin magnesium is complex, involving patents covering the compound itself, its various salt forms, polymorphic forms, manufacturing processes, and formulations. The expiration of key patents has led to increased generic competition.

What are the Core Composition of Matter Patents?

The original composition of matter patent for pitavastatin was filed by Kissei Pharmaceutical Co., Ltd.

• Kissei Pharmaceutical Co., Ltd. held the foundational patent for pitavastatin. The U.S. patent for pitavastatin (often referred to by its chemical name, (3R,5S,6E)-7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyhept-6-enoic acid) has expired. For instance, U.S. Patent No. 5,856,337, related to novel heterocyclic compounds, was granted in 1999. The expiry of such primary patents opened the door for generic development.

What Patents Cover Manufacturing Processes?

Numerous patents have been filed for improved or alternative synthesis routes for pitavastatin and its magnesium salt. These patents aim to enhance yield, purity, reduce costs, or develop more environmentally friendly processes.

• Patents related to the synthesis of pitavastatin often focus on specific chiral resolutions, coupling reactions, or intermediate purifications. For example, patents might detail specific catalysts or solvent systems to achieve higher enantiomeric purity of the active pharmaceutical ingredient.

• Magnesium salt formation patents are crucial as pitavastatin magnesium offers certain advantages in terms of stability and formulation. Companies have patented specific methods for producing the magnesium salt, including control of crystalline form. A key patent for pitavastatin magnesium salt formation was filed by Daiichi Sankyo Company, Limited, the originator of the brand-name drug Livalo®. U.S. Patent No. 7,700,604, concerning a novel magnesium salt of pitavastatin and its preparation, was granted and has since expired, allowing for broader manufacturing by generic companies.

What Patents Cover Polymorphs and Formulations?

Polymorphism, the ability of a solid material to exist in multiple crystalline forms, is critical for drug stability, dissolution, and bioavailability. Patents covering specific polymorphic forms of pitavastatin magnesium can extend market exclusivity.

• Polymorphic form patents for pitavastatin magnesium have been a significant area of patenting activity. For example, patents may claim specific crystalline structures (e.g., Form A, Form B) with defined X-ray diffraction patterns, differential scanning calorimetry (DSC) profiles, or infrared (IR) spectroscopy data. Companies like Daiichi Sankyo have secured patents on specific polymorphs that offer improved pharmaceutical properties.

• Formulation patents cover the final drug product, including tablet compositions, coatings, and excipients used to create the finished dosage form. These patents protect specific ways of delivering pitavastatin magnesium to patients.

What is the Status of Generic Entry and Patent Expirations?

The expiration of key patents, particularly the composition of matter and early manufacturing process patents, has paved the way for generic manufacturers.

• The expiration of the primary U.S. patent for pitavastatin (e.g., U.S. Patent No. 5,856,337) around 2016-2018, depending on market-specific extensions and exclusivities, marked a significant turning point.

• The expiration of patents covering specific magnesium salt forms (e.g., U.S. Patent No. 7,700,604, expired in 2022) further facilitated generic production of this specific salt.

• Orange Book listings in the United States and similar databases in other countries provide detailed information on patents and exclusivities for branded drugs. For Livalo®, these listings have shown the expiration of patents, leading to the approval of generic versions.

• ANDA approvals from regulatory bodies like the FDA signify that generic versions have met bioequivalence and quality standards, allowing them to enter the market. Multiple generic manufacturers have received approvals for pitavastatin magnesium tablets.

Key Takeaways

The supply of pitavastatin magnesium is concentrated among a few API manufacturers, primarily in Asia, who have demonstrated compliance with international regulatory standards. The patent landscape, once dominated by originator companies, has largely seen the expiration of core composition of matter and key manufacturing process patents, leading to significant generic market entry. Ongoing patent activity focuses on specific polymorphic forms and advanced formulation technologies.

FAQs

1. What is the primary therapeutic use of pitavastatin magnesium?

Pitavastatin magnesium is used to lower cholesterol and triglyceride levels in the blood, thereby reducing the risk of cardiovascular events such as heart attacks and strokes. It belongs to the statin class of drugs.

2. Are there any active patents that could block generic pitavastatin magnesium production?

While key patents for the compound and its basic magnesium salt have expired, patents covering specific polymorphic forms or novel manufacturing processes could still be in effect. Generic manufacturers must carefully navigate these to avoid infringement.

3. What regulatory approvals are required for pitavastatin magnesium API suppliers?

Suppliers must adhere to Good Manufacturing Practice (GMP) guidelines and typically need to have their facilities inspected and approved by regulatory agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national health authorities. Drug Master Files (DMFs) are often submitted.

4. How does pitavastatin magnesium differ from other statins?

Pitavastatin magnesium is a synthetic statin that is highly effective in reducing low-density lipoprotein cholesterol (LDL-C). Its efficacy and safety profile are comparable to other statins, but specific differences in pharmacokinetics and drug interactions may exist.

5. What is the typical shelf life and storage condition for pitavastatin magnesium API?

The typical shelf life for pitavastatin magnesium API is usually two to three years when stored under controlled conditions, typically protected from light and moisture at room temperature. Specific storage recommendations are detailed by the manufacturer.

Citations

[1] Kissei Pharmaceutical Co., Ltd. (1999). U.S. Patent No. 5,856,337. United States Patent and Trademark Office.

[2] Daiichi Sankyo Company, Limited. (2010). U.S. Patent No. 7,700,604. United States Patent and Trademark Office.

[3] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book