Glenmark US launches Methylene Blue Injection in 2026

Why Glenmark’s latest US launch matters

Glenmark Pharmaceuticals’ generics business is anchored around North America (the US and Canada) and Europe, and its latest US introductions underline that focus. The company says that in the US market alone it has 215 generic products authorised for distribution. It also states that, with more than 90 million prescriptions filled annually, it ranks 14th in the US market.

Against this backdrop, Glenmark’s US subsidiary has continued to add products across targeted, higher-value categories, including injectables and oncology. The recent Methylene Blue Injection launch is positioned as part of that institutional portfolio expansion.

Methylene Blue Injection USP launch: what was announced

Glenmark Pharmaceuticals Inc., USA announced the launch of Methylene Blue Injection USP, 50 mg/10 mL (5 mg/mL) Single-Dose Vial in the US on June 17, 2026. The company said its product is bioequivalent and therapeutically equivalent to the reference listed drug ProvayBlue Injection (NDA 204630) of Provepharm SAS.

In its communication, Glenmark linked the launch to its focus on expanding access to “quality, affordable medicines” for healthcare institutions and patients. It also described the product as strengthening its institutional portfolio and reinforcing its focus on delivering reliable treatment options across the US market.

IQVIA market size for ProvayBlue tracked at USD 19.0 million

Glenmark cited IQVIA sales data to frame the commercial opportunity. According to IQVIA data for the 12-month period ending April 2026, the ProvayBlue Injection market achieved annual sales of approximately USD 19.0 million.

For investors, the key takeaway is not only the market size, but also that Glenmark is continuing to populate its US basket with products linked to identifiable, tracked reference markets.

Another US generic: Milnacipran authorised generic opportunity

In a separate US generics move, Glenmark Pharmaceuticals Inc., USA launched Milnacipran Hydrochloride Tablets as an authorised generic version of Savella Tablets. The company said the product is available across four dosage strengths: 12.5 mg, 25 mg, 50 mg, and 100 mg.

Glenmark cited IQVIA data showing a market opportunity worth USD 103 million annually for the 12-month period ending January 2026. The company positioned the launch as strengthening its presence in the US generic pharmaceutical market while offering a more cost-effective treatment alternative.

A high-value injectable pipeline: Sodium Phosphates Injection plan

Glenmark also disclosed preparations to introduce a new generic injection in the US through its US-based unit. In a regulatory filing, the company confirmed that the product is therapeutically equivalent to the reference listed drug currently produced by Hosira Inc.

The company stated that distribution of Sodium Phosphates Injection in the US market is slated to begin in April 2026. As per IQVIA sales data for the 12 months ending December 2025, single-dose vials of Sodium Phosphates Injection USP generated annual sales of approximately USD 66.8 million.

Oncology and complex generics: Eribulin Mesylate Injection

Glenmark Pharmaceuticals Inc., USA also announced its readiness to introduce Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials in the US market. The company described the product as bioequivalent and therapeutically equivalent to Eisai Inc.’s Halaven Injection, 1 mg/2 mL (0.5 mg/mL).

It stated that distribution will begin in September 2025. The reference brand’s annual sales were cited at USD 66.30 million, and the launch was framed as an expansion of Glenmark’s presence in oncology and complex generics.

India strategy alongside the US: GLIPIQ (Semaglutide)

While the US launches centre on generics and injectables, Glenmark has also expanded its India portfolio. Following approval from the Central Drugs Standard Control Organization (CDSCO), Glenmark Pharmaceuticals launched Glipiq, described as a biosimilar version of the GLP-1 receptor agonist semaglutide.

The company also announced GLIPIQ (Semaglutide) in India for Type 2 Diabetes Mellitus management with weekly treatment starting at ₹325-₹440. Separately, it has stated it is targeting 20% CAGR growth in India.

Manufacturing footprint and delivery systems mentioned by the company

Glenmark has referenced manufacturing and capability expansion across geographies in relation to its broader generics build-out. The provided information points to a manufacturing facility at Monroe, North Carolina, US, and facilities in Goa and Sinnar in India.

It also mentions Novel Drug Delivery Systems (NDDS) and formats including liposomes and dry powder inhalers. In addition, the company notes it received its first injectable approval in the US for Bendamustine Hydrochloride, describing it as marking entry into the generics injectables segment.

Partnership route: InvaGen deal and planned US filings

Glenmark has previously used partnerships to scale its US pipeline. It said it partnered with InvaGen Pharmaceuticals Inc to develop and market seven generic pharmaceutical products in the US, covering off-patent and patent-protected molecules with cumulative annual sales of about USD 4,100 million.

Under the arrangement described, InvaGen would develop and licence the products to Glenmark, file ANDAs, and manufacture and supply the products, while Glenmark would obtain regulatory approval and its US subsidiary would exclusively market them. Glenmark also said one ANDA had already been filed and three more were expected to be filed by March the following year.

Key product and market snapshot

Market impact: what the data points indicate

The most direct market indicators in the information provided are the IQVIA-reported reference market sizes and the cadence of Glenmark’s product additions. The launches cited span institutional injectables (Methylene Blue), an authorised generic tablet opportunity (Milnacipran), a planned injectable distribution start (Sodium Phosphates), and an oncology-focused complex generic (Eribulin).

Alongside those launches, Glenmark’s scale indicators in the US include 215 generic products authorised for distribution and a stated ranking of 14th in the US market based on more than 90 million prescriptions filled annually. The company has also disclosed a US pipeline base of more than 110 approved ANDAs, with an additional 135 products under regulatory review or in development, and an expectation to file 20-25 ANDAs in the US.

Conclusion

Glenmark’s June 2026 Methylene Blue Injection launch, backed by an IQVIA-tracked reference market of USD 19.0 million, fits into a broader pattern of US portfolio additions across injectables, complex generics, and authorised generics. The company has also outlined specific upcoming steps, including beginning distribution of Sodium Phosphates Injection in April 2026 and starting Eribulin distribution in September 2025, while continuing to expand in India through products such as Glipiq after CDSCO approval.