ANI Pharmaceuticals Announces the Launch of Duloxetine Delayed-Release Capsules

U.S. annual sales for Duloxetine Delayed-Release Capsules totaled approximately $247 million, based on August 2026 IQVIA data.

Rhea-AI Summary

ANI Pharmaceuticals (Nasdaq: ANIP) has launched Duloxetine Delayed-Release Capsules, adding a generic version of Cymbalta to its product offerings. The capsules are available in 20, 30 and 60 mg strengths. The company said the launch provides another treatment alternative in a market with limited suppliers, with the aim of supporting stable supply.

News Explained

The company cites U.S. annual sales for duloxetine delayed-release capsules of approximately $247 million based on August 2026 MAT IQVIA data; this is market sales context, not an ANI-specific sales amount.

Key Figures

U.S. annual sales: $247 million Available strengths: 20, 30 and 60 mg

U.S. annual sales

$247 million

August 2026 MAT IQVIA data

Available strengths

20, 30 and 60 mg

Duloxetine delayed-release capsules

Key Terms

delayed-release, reference listed drug, moving annual total

3 terms

delayed-release technical

"ANI Pharmaceuticals Announces the Launch of Duloxetine Delayed-Release Capsules"

A delayed-release drug formulation is engineered so the active ingredient is released at a later point after administration rather than immediately on swallowing; this is typically achieved with coatings or internal barriers that prevent release until a specific time or location in the digestive tract (for example, after passing the stomach). It differs from extended‑ or sustained‑release formulations, which spread drug release over an extended period; delayed‑release creates a lag before release, while extended‑release controls the rate of release. The term does not specify how long the delay is or the exact release site, which are determined by the product’s design and regulatory labeling.

reference listed drug regulatory

"the generic version of the reference listed drug (RLD) Cymbalta"

A reference listed drug is the approved, original version of a medicine that regulators use as the official “master copy” when evaluating generic versions for safety, strength and how the body absorbs it. For investors, the RLD determines what competitors must match to win approval, shaping how quickly lower‑priced generics can enter the market and therefore affecting future sales, pricing pressure and legal disputes over market exclusivity.

moving annual total technical

"based on August 2026 moving annual total (MAT) IQVIA data"

A moving annual total (MAT) is the sum of a company’s financial metric—such as sales, revenue, or units sold—over the most recent 12-month period, updated each month or quarter like a rolling window. Investors use it to smooth out seasonal ups and downs and reveal underlying trends, making performance comparisons and growth analysis clearer than looking at one-off quarterly figures; think of it as a 12-month running score that filters short-term noise.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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PRINCETON, N.J., Oct. 19, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the launch of Duloxetine Delayed-Release Capsules 20, 30 and 60 mg. ANI’s Duloxetine Delayed-Release Capsules are the generic version of the reference listed drug (RLD) Cymbalta^®.

“By launching Duloxetine Delayed-Release Capsules, ANI is providing another alternative of a widely used therapy in a limited player market to assure stable supply. Through close customer and manufacturer partnerships and a focused regulatory effort, we are proud to make this important and widely used therapy available to patients and providers,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

U.S. annual sales for Duloxetine Delayed-Release Capsules totaled approximately $247 million, based on August 2026 moving annual total (MAT) IQVIA data.

About ANI Pharmaceuticals, Inc.

ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company committed to its mission of “Serving Patients, Improving Lives” by developing, manufacturing, and commercializing innovative and high-quality therapeutics. The Company is focused on delivering sustainable growth through its Rare Disease business, which markets novel products in the areas of ophthalmology, rheumatology, nephrology, neurology, and pulmonology; its Generics business, which leverages R&D expertise, operational excellence, and U.S.-based manufacturing; and its Brands business. For more information, visit https://www.anipharmaceuticals.com.

Forward-Looking Statements

To the extent any statements made in this release relate to information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the Company’s strategy; its plans with respect to the commercialization and potential sales of the Company’s products, including the launch of Duloxetine Delayed-Release Capsules; its efforts to bring limited-competition products to market and ensure that is high-quality products are readily accessible to its customers and patients in need; expansion plans for the Company’s Rare Disease, Generics and Brands businesses; and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” the negatives thereof, or other words of similar meaning, derivations of such words and the use of future dates.

Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to: the ability of the Company’s approved products to achieve commercialization at levels of market acceptance that will allow the Company to maintain profitability; delays and disruptions in the production of the Company’s approved products; delays or failure to obtain or maintain approvals by the FDA of the Company’s products; changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration and other regulatory agencies; risks that the Company may face with respect to importing raw materials and delays in delivery of raw materials and other ingredients and supplies necessary for the manufacture of the Company’s products from both domestic and overseas sources due to supply chain disruptions or for any other reason; the limited number of suppliers for active pharmaceuticals ingredients for our products; the ability of the Company’s manufacturing partners to meet its product demands and timelines; the level of competition the Company faces and the legal, regulatory and/or legislative strategies employed by its competitors to prevent or delay competition from generic alternatives to branded products; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the Company’s ability, and that of its suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; legal proceedings and product liability claims relating to our products and our business; and general business and economic conditions, such as inflationary pressures and geopolitical conditions.

More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission (SEC), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, and other periodic reports, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Relations:
Irina Koffler, Vice President, Investor Relations
T: 917-734-7387
E: Irina.koffler@anipharmaceuticals.com

Media Relations:
Argot Partners
T: 212-600-1494
E: ani@argotpartners.com

Source: ANI Pharmaceuticals, Inc.