Zenara Secures First Generic Sertraline Approval from FDA, Plus Six Months of Market Exclusivity

Zenara Pharma, an India-based subsidiary of Biophore, has received final approval from FDA for an abbreviated new drug application (ANDA) for sertraline hydrochloride capsules, in 150mg and 200mg doses, as selective serotonin reuptake inhibitors (SSRIs) for the treatment of major depressive disorder (MDD) in adults and obsessive-compulsive disorder (OCD) in both adults and pediatric patients aged six and older (1).

First generic approval

FDA’s approval is the first in the United States for a generic form of the reference sertraline hydrochloride drug marketed by Almatica Pharma (1). US sales of the reference product in the 12 months ending in June 2025 totaled $35.5 million, according to IQVIA.

Zenara’s version has also been granted competitive generic therapy designation, under the terms of which Zenara’s ANDA has 180 days of marketing exclusivity in the US, commencing with the product’s launch.

Seeking solutions for MDD

"Receiving the first generic approval for sertraline hydrochloride capsules highlights Zenara's strong R&D capabilities and operational excellence,” Srinivas Arutla, PhD, CEO of Zenara, said in a press release (1). “We remain committed to our mission of delivering to patients early access to high-quality, affordable pharmaceuticals."

Finding suitable treatments for MDD has been a goal for drug developers in recent years. In 2023, Evecxia Therapeutics and Quotient Sciences reported the success of a Phase I clinical testing program for Evecxia’s EVX-101, an adjunctive treatment for MDD for patients who experienced an inadequate response to first-line antidepressants such as SSRIs (2).

Below are some broader impacts to the pharmaceutical industry based on the news from Zenara.

Drug discovery and development

FDA’s cell and gene therapy (CGT) pathway aims to incentivize applicants to pursue competitive generics in markets with insufficient generic competition. Companies achieving first‑approval status can secure a six‑month exclusivity window in the US. For R&D teams, this underlines the value of strategic application timing and patent‑challenge readiness, especially for legacy molecules with high sales but limited generic entrants.

Scientific teams should note the therapeutic significance of sertraline as a widely prescribed SSRI. Generics in this space must replicate key pharmaceutical properties—dissolution profile, impurity thresholds, and bioequivalence performance—to qualify for FDA approval.

Manufacturing and supply chain

Zenara’s successful development and scale‑up suggest strong end‑to‑end capabilities in formulation and manufacturing. Vertical integration appears central to their competitive positioning, enabling efficient API sourcing, scale‑up validation, and good manufacturing practice compliance to support timely ANDA filing and commercial launch. For drug manufacturing organizations, this vertical integration moves beyond a simple reference drug copy strategy toward more strategic, agile platforms that prioritize rapid ANDA execution and commercial readiness to capture CGT incentives.

Strategic considerations for stakeholders

• Pipeline prioritization: Companies working in drug discovery should monitor FDA CGT designations and Orange Book listings to identify potential high‑value targets for generic development when exclusivities expire.
• Regulatory planning: Intellectual property teams must assess active patents and exclusivities early to establish first‑to‑file status and preserve eligibility for CGT exclusivity.
• Commercial alignment: Launch timing is critical. To avoid forfeiture of CGT exclusivity, first approved applicants must commercially market within 75 days of approval. Coordination between regulatory, manufacturing, and commercial functions is therefore imperative.

The approval won by Zenara illustrates how generic developers can harness regulatory incentives to bring affordable versions of widely used molecules to market. For drug discovery and development professionals, it exemplifies an emerging business model: targeting established, high‑volume drugs through accelerated pathways, leveraging robust formulation science and tight regulatory execution, rather than pursuing novel chemical entities exclusively.

References

1. Zenara. Zenara Pharma Receives US FDA Approval for First Generic of Sertraline Hydrochloride Capsules with 180-Day CGT Exclusivity. Press Release. Aug. 1, 2025.
2. Quotient Sciences. Evecxia Therapeutics Reports Favorable Data from a Phase I SAD/MAD Trial. Press Release. Apr. 10, 2023.