ANI Pharmaceuticals Announces the Launch of Carbamazepine Extended-Release Capsules

ANI Pharmaceuticals (Nasdaq: ANIP) launched Carbamazepine Extended-Release Capsules in 100 mg, 200 mg and 300 mg strengths on April 13, 2026.

Rhea-AI Summary

ANI Pharmaceuticals (Nasdaq: ANIP) launched Carbamazepine Extended-Release Capsules in 100 mg, 200 mg and 300 mg strengths on April 13, 2026.

The product is a generic version of the reference listed drug Carbatrol. ANI said the launch targets a limited competition segment and cited U.S. annual sales of approximately $65 million based on February 2026 MAT IQVIA data.

Positive

• Launch of Carbamazepine ER in 100/200/300 mg expands generics portfolio
• Product is a generic of Carbatrol, enabling substitution opportunities
• Addresses a U.S. market with estimated $65 million annual sales (Feb 2026 MAT IQVIA)

Negative

• None.

Argus Apr 13 session

-0.06% close to close Open Argus

Details

News Market Reaction – ANIP

On Apr 13, the day this news came out, ANIP closed 0.06% below the previous close.

Data tracked by StockTitan Argus for the Apr 13 session.

Market Context

This announcement adds another limited-competition generic, Carbamazepine Extended-Release Capsules,...

Analysis

This announcement adds another limited-competition generic, Carbamazepine Extended-Release Capsules, targeting a U.S. market of about $65 million in annual sales. It follows recent product launches and record 2025 financial results, reinforcing ANI’s emphasis on generics alongside rare disease. Investors may track how quickly this product captures share, how pricing evolves in a limited-competition setting, and how additional launches contribute to the company’s goal of expanding its generics portfolio.

Key Figures

Carbamazepine strength: 100 mg Carbamazepine strength: 200 mg Carbamazepine strength: 300 mg +1 more

Carbamazepine strength

100 mg

Carbamazepine Extended-Release Capsules dosage strength

Carbamazepine strength

200 mg

Carbamazepine Extended-Release Capsules dosage strength

Carbamazepine strength

300 mg

Carbamazepine Extended-Release Capsules dosage strength

U.S. annual sales

$65 million

U.S. annual sales for Carbamazepine ER, Feb 2026 MAT IQVIA data

Historical Context

5 past events · Latest: Apr 08

5 events

1. Apr 08

   FDA approval launch

   24h Move

   -0.6%

   FDA approval and launch of Isosorbide Mononitrate generic tablets.

2. Apr 07

   Clinical data update

   24h Move

   +2.9%

   Publication of Phase 4 ILUVIEN NEW DAY trial safety and efficacy data.

3. Feb 27

   Earnings results

   24h Move

   -4.2%

   Record Q4 and 2025 results with strong revenue and EBITDA growth.

4. Feb 24

   Investor conferences

   24h Move

   +2.1%

   Announcement of multiple March investor conference presentations.

5. Feb 13

   Earnings call notice

   24h Move

   +0.9%

   Scheduling details for Q4 and full-year 2025 earnings release and call.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

reference listed drug, extended-release, moving annual total

3 terms

reference listed drug regulatory

"the generic version of the reference listed drug (RLD) Carbatrol®."

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.

extended-release medical

"the launch of Carbamazepine Extended-Release Capsules, 100 mg, 200 mg and 300 mg."

Extended-release is a drug formulation designed to release its active ingredient slowly over an extended period so the medicine stays at steadier levels in the body and usually needs to be taken less often—think of a timed-release coffee versus sipping many short espressos. Investors care because extended-release versions can improve patient adherence, reduce side effects, and create product differentiation that supports higher pricing, longer commercial lifecycles, and clearer revenue visibility, while also attracting specific regulatory and manufacturing considerations.

moving annual total financial

"based on February 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., April 13, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the launch of Carbamazepine Extended-Release Capsules, 100 mg, 200 mg and 300 mg. ANI’s Carbamazepine Extended-Release Capsules are the generic version of the reference listed drug (RLD) Carbatrol^®.

"Continuing to strengthen our Generics portfolio through strategic product launches remains a key priority for us,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI. “The launch of Carbamazepine Extended-Release Capsules, another limited competition product, highlights our continued commitment to improving patient access to essential medicines while maintaining the highest standards of quality and compliance.”

U.S. annual sales for Carbamazepine Extended-Release Capsules total approximately $65 million, based on February 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 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 Carbamazepine Extended-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 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; 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:
Courtney Mogerley, Argot Partners
T: 646-368-8014
E: ani@argotpartners.com

Source: ANI Pharmaceuticals, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did ANI Pharmaceuticals (ANIP) announce on April 13, 2026 about carbamazepine?

ANI announced the launch of Carbamazepine Extended-Release Capsules in 100/200/300 mg strengths. According to the company, the product is the generic version of Carbatrol and targets a limited-competition segment to improve patient access.

Which strengths of Carbamazepine ER did ANIP introduce and what is the RLD?

ANI introduced 100 mg, 200 mg and 300 mg extended-release capsules. According to the company, the product is the generic equivalent of the reference listed drug Carbatrol, enabling substitution where permitted.

How large is the U.S. market for Carbamazepine ER cited by ANIP (ANIP)?

ANI cited U.S. annual sales of approximately $65 million based on February 2026 MAT IQVIA data. According to the company, this figure reflects the moving annual total used to size the addressable market.

What strategic rationale did ANIP give for launching Carbamazepine ER (ANIP)?

ANI said the launch strengthens its generics portfolio and targets a limited competition product area. According to the company, the move aims to improve patient access while maintaining quality and compliance standards.

Will the ANIP Carbamazepine ER launch likely affect patient access to the drug?

ANI indicated the launch is intended to improve patient access to an essential medicine. According to the company, offering a generic of Carbatrol should expand substitution and availability in markets where generic alternatives are accepted.