Senores acquires USFDA-approved Enalapril Maleate ANDA from Wockhardt for US market

Team Finance Saathi

    20/May/2025

What's covered under the Article:

  1. Senores Pharmaceuticals acquires USFDA-approved ANDA for Enalapril Maleate from Wockhardt.

  2. The acquisition is funded through IPO proceeds and aligns with the company's expansion strategy.

  3. Enalapril market in the US valued at approximately USD 109.24 million as per March 2025 data.

Atlanta, USA / Ahmedabad, India – May 20, 2025:
Senores Pharmaceuticals Limited (SPL) has made a strategic move to boost its presence in the US generic pharmaceutical market. The company, through its wholly-owned US subsidiary, Senores Pharmaceuticals, Inc. (SPI), has acquired the USFDA-approved Abbreviated New Drug Application (ANDA) for Enalapril Maleate Tablets (2.5mg, 5mg, 10mg, and 20mg) from Wockhardt Limited, a global pharmaceutical and biotechnology major.


What is Enalapril Maleate and Its Market Significance?

Enalapril Maleate is a widely used ACE inhibitor (Angiotensin-Converting Enzyme Inhibitor) that plays a critical role in managing:

  • Hypertension (high blood pressure)

  • Congestive heart failure

  • Asymptomatic left ventricular dysfunction

With increasing prevalence of cardiovascular diseases in the US, the demand for cost-effective generic formulations of such drugs has risen steadily.

According to IQVIA, the market size of Enalapril Tablets in the US was approximately USD 28.60 million as of MAT December 2024, while Symphony, a specialty data aggregator, estimates the market to be around USD 109.24 million as of MAT March 2025.


Details of the Acquisition

The acquisition marks another milestone for Senores Pharmaceuticals Limited, which has been aggressively expanding its footprint in regulated markets. By acquiring this approved ANDA, Senores is securing a ready-to-launch product in the US without waiting for lengthy approval processes.

Most importantly, this acquisition is funded through the proceeds of SPL’s Initial Public Offer (IPO). The use of IPO funds aligns directly with the strategic objectives outlined in the company’s Red Herring Prospectus, demonstrating commitment to its roadmap for growth and innovation.


How Does This Strengthen Senores’ US Portfolio?

Senores Pharmaceuticals, Inc. USA has been actively building its US product pipeline, focusing on high-potential therapeutic segments like cardiovascular, anti-diabetic, and CNS (central nervous system).

The acquisition of Enalapril Maleate Tablets significantly strengthens Senores' offerings in the cardiology segment. Since the product already holds USFDA approval, it enables quicker market entry and potential revenue generation in the short term.


The Role of IPO Proceeds in Strategic Acquisitions

Initial Public Offerings (IPOs) allow companies to raise capital from the public for strategic business objectives. In this case, SPL clearly stated in its Red Herring Prospectus that part of the IPO proceeds would be utilized for acquiring approved ANDAs and other inorganic growth initiatives.

With the Enalapril Maleate acquisition, SPL showcases transparency and focus, as the deal fits precisely within the boundaries laid out during its IPO filing. This also builds investor confidence by showing swift action post-IPO and responsible use of raised capital.


Wockhardt’s Strategy and Focus

Wockhardt Limited, the seller in this transaction, has also been undergoing portfolio optimization. The company is focusing more on its core therapeutic areas and biosimilars, especially in emerging markets and the UK.

By selling off non-core generic assets, Wockhardt is freeing up resources for areas with better margin potential and innovation-led products. The Enalapril deal reflects this ongoing portfolio rationalization strategy.


Why is the US Generic Market Attractive for Indian Pharma?

India is often called the pharmacy of the world, and its companies continue to dominate the US generic space, which is the largest pharmaceutical market globally.

For Indian firms like Senores, acquiring USFDA-approved ANDAs is:

  • A fast-track method to enter the US market

  • A way to avoid time-consuming and expensive drug development

  • An opportunity to generate early revenues and market presence

The US FDA's regulatory framework makes it possible for Indian manufacturers to supply high-quality generics, creating a win-win scenario for both American patients and Indian pharma companies.


Future Outlook for Senores Pharmaceuticals

With this acquisition, Senores Pharmaceuticals is expected to scale its revenues in the US, with Enalapril Maleate Tablets likely serving as a significant contributor.

The company is also expected to continue pursuing additional ANDA acquisitions or even strategic partnerships, possibly in high-margin segments like:

  • Injectables

  • Ophthalmology

  • Dermatology

Additionally, Senores may explore filing new ANDAs in-house, supported by its R&D centers in India.


Conclusion

The acquisition of the Enalapril Maleate ANDA from Wockhardt is a strategic masterstroke by Senores Pharmaceuticals. It reflects the company’s agile post-IPO strategy, clear focus on international markets, and ability to leverage regulatory approvals for immediate commercial benefit.

This move positions Senores not only as a generic supplier but also as a growing player in the global pharma arena, well-aligned with market needs and shareholder expectations.

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