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Last Updated: June 14, 2025

Zydus Company Profile


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Summary for Zydus
International Patents:4
US Patents:1
Tradenames:314
Ingredients:304
NDAs:386
Patent Litigation for Zydus: See patent lawsuits for Zydus

Drugs and US Patents for Zydus

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms Usa Inc ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 079017-004 Sep 16, 2010 AB RX No No ⤷  Try for Free ⤷  Try for Free
Zydus Lifesciences INDOMETHACIN indomethacin CAPSULE;ORAL 090403-002 Nov 15, 2010 AB RX No No ⤷  Try for Free ⤷  Try for Free
Zydus Pharms EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE empagliflozin; metformin hydrochloride TABLET;ORAL 212198-003 Jul 7, 2022 DISCN No No ⤷  Try for Free ⤷  Try for Free
Zydus Pharms METOPROLOL TARTRATE metoprolol tartrate TABLET;ORAL 212402-001 Apr 19, 2023 DISCN No No ⤷  Try for Free ⤷  Try for Free
Zydus Lifesciences DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 210700-005 Mar 23, 2023 BX RX No No ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for ZYDUS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe for Injection 100 mcg/vial and 500 mcg/vial ➤ Subscribe 2015-04-14
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 2015-06-03
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 2015-05-01

Supplementary Protection Certificates for Zydus Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1345920 SPC/GB14/018 United Kingdom ⤷  Try for Free PRODUCT NAME: MACITENTAN, WHICH IS N-(5-(4-BROMOPHENYL)-6-(2((5-BROMOPYRIMIDIN-2-YL)OXY)ETHOXY)PYRIMIDIN-4-YL)-N'-PROPYLSULFURIC DIAMIDE; REGISTERED: UK EU/1/13/893 20131220
0392059 2002C/035 Belgium ⤷  Try for Free PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
2059246 CA 2024 00050 Denmark ⤷  Try for Free PRODUCT NAME: KOMBINATION AF (A) MACITENTAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG (B) TADALAFIL ELLER ET FAR-MACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/24/1859 20240930
2187879 CA 2017 00019 Denmark ⤷  Try for Free PRODUCT NAME: KOMBINATION AF EMPAGLIFLOZIN OG LINAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/16/1146/001-018 20161115
0720599 122004000026 Germany ⤷  Try for Free PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 58866.00.00 58866.01.00 58866.02.00 58866.03.00 58870.00.00 58870.01.00 58870.02.00 58870.03.00 58874.00.00 58874.01.00 58874.02.00 58874.03.00 58878.00.00 58878.01.00 58878.02.00 58878.03.00 20040402 FIRST REGISTRATION: DE 58866.00.00 - 58866.03.00 58870.00.00 - 58870.03.00 58874.00.00 - 58874.03.00 58878.00.00 - 58878.03.00 20040402
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Zydus Lifesciences: A Powerhouse in the Pharmaceutical Landscape

In the ever-evolving world of pharmaceuticals, Zydus Lifesciences has emerged as a formidable player, carving out a significant niche for itself in the global market. Let's dive into the company's market position, strengths, and strategic insights that have propelled it to the forefront of the industry.

The Zydus Journey: From Local to Global

Zydus Lifesciences, formerly known as Cadila Healthcare, has come a long way since its inception in 1952. What started as a local pharmaceutical venture has now blossomed into a multinational corporation with a presence in 55 countries[1]. This remarkable growth trajectory speaks volumes about the company's vision and execution capabilities.

A Legacy of Innovation

At the heart of Zydus's success lies its commitment to innovation. The company's research and development efforts have led to groundbreaking achievements, including the world's first plasmid DNA vaccine for COVID-19, ZyCoV-D[1]. This innovative spirit has not only positioned Zydus as a pioneer in the field but has also opened up new avenues for growth and market expansion.

Market Position: Climbing the Ranks

Zydus Lifesciences has steadily climbed the ranks to become a major player in the pharmaceutical industry. Let's look at some key indicators of its market position:

Global Footprint

With operations spanning 55 countries, Zydus has truly gone global[1]. This extensive reach allows the company to tap into diverse markets and mitigate risks associated with regional economic fluctuations.

Revenue Growth

The company's financial performance has been impressive, with total revenues reaching over 100 billion Indian rupees in the financial year 2024[8]. This consistent growth trajectory underscores Zydus's strong market position and its ability to capitalize on emerging opportunities.

US Market Penetration

Zydus Pharmaceuticals (USA) Inc., the company's US arm, has made significant inroads into the American market. It's currently ranked as the fifth largest unbranded generic corporation in the US based on dispensed prescriptions[7]. This achievement is particularly noteworthy given the highly competitive nature of the US pharmaceutical market.

Strengths: The Pillars of Success

Zydus's market success can be attributed to several key strengths that set it apart from its competitors:

Diverse Product Portfolio

Zydus boasts a comprehensive product range that spans various therapeutic areas. From generics to specialty drugs, the company's diverse portfolio helps it cater to a wide range of healthcare needs[5].

Robust R&D Capabilities

With over 300 products in various stages of development and 129 drug master files (DMFs) filed, Zydus demonstrates a strong commitment to research and development[7]. This focus on innovation ensures a steady pipeline of new products, keeping the company at the forefront of pharmaceutical advancements.

Manufacturing Excellence

Zydus operates more than 30 manufacturing plants worldwide, ensuring a reliable supply chain and quality control[1]. This manufacturing prowess not only supports the company's growth but also enhances its reputation for delivering high-quality products consistently.

Strategic Acquisitions

The company has strategically expanded its capabilities through acquisitions. For instance, in 2022, Zydus acquired a 100% stake in a US-based firm for ₹500 crores, enhancing its specialty product portfolio[3].

Strategic Insights: Navigating the Future

To maintain its competitive edge, Zydus has adopted several strategic initiatives:

Focus on Complex Generics

Zydus is actively expanding its portfolio of complex generics, including modified release solid orals, transdermals, injectables, and oral suspensions[7]. This strategy allows the company to tap into higher-margin products and differentiate itself in a crowded market.

Expansion in International Markets

While maintaining a strong presence in India, Zydus is aggressively expanding its footprint in key international markets, particularly the US and Europe. In 2023, the company achieved sales of ₹4,500 crores from international markets, marking a growth of 15% compared to the previous fiscal year[3].

Investment in Biosimilars

Recognizing the growing importance of biologics, Zydus is investing heavily in biosimilar development. The company's launch of the world's first adalimumab biosimilar under the brand name Exemptia showcases its capabilities in this high-growth segment[4].

Digital Transformation

Zydus is embracing digital technologies to enhance its operations and customer engagement. The company's investment in digital initiatives is expected to improve efficiency, reduce costs, and create new avenues for growth[6].

Challenges and Opportunities

Despite its strong position, Zydus faces several challenges:

Regulatory Scrutiny

The pharmaceutical industry is subject to stringent regulatory oversight. Zydus must continue to invest in quality control and compliance to maintain its reputation and market access.

Price Pressures

Increasing competition and government price controls, particularly in the Indian market, pose challenges to profitability. Zydus needs to continually optimize its operations to maintain margins.

R&D Risks

While Zydus's strong R&D focus is a strength, it also exposes the company to risks associated with drug development failures and regulatory delays.

However, these challenges also present opportunities:

Emerging Markets

Zydus can leverage its experience in India to expand into other emerging markets with similar healthcare needs and economic profiles.

Specialty and Orphan Drugs

By focusing on niche therapeutic areas and rare diseases, Zydus can tap into high-value market segments with less competition.

Digital Health

The growing intersection of healthcare and technology presents opportunities for Zydus to develop digital health solutions that complement its pharmaceutical offerings.

"Zydus Lifesciences is India's fourth largest pharmaceutical company with more than 30 manufacturing plants worldwide and business operations in 55 countries."[1]

Future Outlook

The future looks promising for Zydus Lifesciences. Analysts project a Compound Annual Growth Rate (CAGR) of 10% in revenue from FY 2024 to FY 2026[3]. This growth is expected to be driven by:

  1. Continued expansion in international markets
  2. Launch of new complex generics and specialty products
  3. Advancements in biosimilar development
  4. Strategic partnerships and acquisitions

Key Takeaways

  • Zydus Lifesciences has transformed from a local Indian pharmaceutical company to a global player with operations in 55 countries.
  • The company's focus on innovation, exemplified by achievements like the world's first plasmid DNA vaccine, sets it apart in the industry.
  • Zydus's diverse product portfolio, strong R&D capabilities, and manufacturing excellence are key pillars of its success.
  • Strategic initiatives focusing on complex generics, international expansion, and biosimilars position Zydus for future growth.
  • While facing challenges such as regulatory scrutiny and price pressures, Zydus also has significant opportunities in emerging markets and specialty drugs.
  • Analysts project a 10% CAGR in revenue for Zydus from FY 2024 to FY 2026, indicating a positive outlook for the company.

FAQs

  1. What is Zydus Lifesciences' current market position in the US? Zydus Pharmaceuticals (USA) Inc. is ranked as the fifth largest unbranded generic corporation in the US based on dispensed prescriptions.

  2. How has Zydus Lifesciences contributed to the fight against COVID-19? Zydus developed ZyCoV-D, the world's first plasmid DNA vaccine for COVID-19, which was approved for human use in India.

  3. What are some of the key growth drivers for Zydus Lifesciences? Key growth drivers include product innovations, market expansions, strategic acquisitions, and a focus on complex generics and biosimilars.

  4. How is Zydus Lifesciences addressing the challenges of price pressures in the pharmaceutical industry? Zydus is focusing on high-value segments like complex generics and specialty drugs, while also optimizing its operations to maintain profitability.

  5. What is Zydus Lifesciences' strategy for international expansion? The company is aggressively expanding in key markets like the US and Europe, while also exploring opportunities in emerging markets that have similar healthcare needs to India.

Sources cited: [1] https://zydususa.com/overview/ [2] https://www.cnbctv18.com/market/zydus-lifesciences-share-price-us-sales-sitagliptin-impact-grevlimid-competition-returns-19537112.htm [3] https://dcfmodeling.com/blogs/health/zyduslifens-financial-health [4] https://en.wikipedia.org/wiki/Zydus_Lifesciences [5] https://zydususa.com [7] https://www.pharmacytimes.com/view/zydus-pharmaceuticals-usa-inc-profile [8] https://www.statista.com/statistics/1481888/zydus-lifesciences-total-revenue/

Last updated: 2025-02-12

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