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Viatris Inc. (VTRS) Gains FDA Approval for First Generic Iron Sucrose Injection

By Laiba Immad | September 23, 2025, 7:10 PM

In this article, we will be taking a look at the 10 Best Pharma Stocks to Buy According to Billionaires. Viatris Inc. is one of them.

Viatris Inc. (NASDAQ:VTRS), formed from the 2020 merger of Mylan and Pfizer’s Upjohn division, delivers essential generic and specialty medicines to patients in over 165 countries. The company maintains a broad portfolio across multiple therapeutic areas, focusing on sustainable growth, operational discipline, and shareholder returns.

In September 2025, the corporation achieved a key milestone with FDA approval for its first generic Iron Sucrose Injection, USP, a complex generic version of Venofer. The injection, intended for iron deficiency anemia in chronic kidney disease patients, is available in three strengths (50 mg/2.5 mL, 100 mg/5 mL, 200 mg/10 mL), with two strengths awarded Competitive Generic Therapy (CGT) designation, granting 180 days of market exclusivity. With Venofer generating $515 million in annual U.S. sales, this approval significantly strengthens the business’ injectable portfolio and reinforces its expertise in complex generics.

Viatris Inc. (NASDAQ:VTRS) also posted strong Q2 2025 results, reporting revenues of $3.58 billion and adjusted EPS of $0.62, exceeding expectations while maintaining top-half guidance for the year. The firm returned over $630 million to shareholders year-to-date, including $350 million in share buybacks. Pipeline progress continues with positive outcomes from five Phase 3 studies, notably ophthalmic solutions for night vision impairment and presbyopia, supporting upcoming FDA submissions.

Viatris Inc. (VTRS) Gains FDA Approval for First Generic Iron Sucrose Injection

Leadership and organizational enhancements complement these developments. Andrew Enrietti was appointed Chief Administrative and Transformation Officer, and David Simmons joined the board to strengthen strategic oversight. Presentations at PAINWeek 2025 further highlighted Viatris Inc. (NASDAQ:VTRS)’ R&D capabilities and commitment to clinical innovation in pain management.

While we acknowledge the potential of VTRS as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock.

READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy NOW 

Disclosure: None.

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