ANI Pharmaceuticals

What ANI Pharmaceuticals does

ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) is a US-based diversified biopharmaceutical company founded in 1996, headquartered in Baudette, Minnesota, with a commercial headquarters in Princeton, New Jersey. The company operates through two principal business segments. The Rare Disease segment is anchored by Purified Cortrophin Gel (repository corticotropin injection), an FDA-approved therapy for multiple indications including multiple sclerosis, rheumatoid arthritis, nephrotic syndrome, and acute gouty arthritis flares, as well as the ophthalmology franchise ILUVIEN (fluocinolone acetonide intravitreal implant for diabetic macular edema) and YUTIQ (fluocinolone acetonide intravitreal implant for chronic non-infectious uveitis) acquired through the September 2024 acquisition of Alimera Sciences for $381 million. The Generics segment comprises over 100 products across multiple dosage forms including immediate and modified release tablets, capsules, oral solutions, topicals, and injectables, addressing cardiovascular, central nervous system, anti-infective, and other therapeutic categories.

The company's core technology centers on specialized US-based pharmaceutical manufacturing capabilities. These include a 47,000 sq. ft. containment facility for potent compound processing, diverse granulation methods (wet, dry, fluid bed 15-220 kg, and direct compression), liquid dose manufacturing from 25 to 1000 gallons, and topical formulation capabilities, supported by a fully automated solid dose packaging line with serialization and blister capabilities up to 35 indexes per minute. ANI pursues limited-competition generic products with regulatory exclusivities such as 180-day Competitive Generic Therapy (CGT) designation (e.g., Pimozide Tablets).

ANI generates revenue primarily through pharmaceutical product sales across specialty pharmacy channels for rare disease therapies and wholesale/retail distribution for generics. Cortrophin Gel revenue reached $347 million in FY2025 (up 76% YoY), and Q1 2026 revenue was $237.5 million (up 20.5% YoY) with the Rare Disease segment expected to represent approximately 60% of FY2026 revenue. The company also holds a 3.125% perpetual royalty obligation on YUTIQ and ILUVIEN net revenues acquired from SWK Funding for $17.25 million. FY2026 revenue guidance is $1.08-1.14 billion, with adjusted EBITDA of $63.0 million in Q1 2026 and the company entering 2026 with $286 million in cash and a 1.5x net leverage ratio.

Name

ANI Pharmaceuticals

Legal name

ANI Pharmaceuticals, Inc.

Website

https://anipharmaceuticals.com

Company type

Public

Founded year

1996

Operating status

Operating

Headcount range

501–1,000 employees

Short description

ANI Pharmaceuticals is a US-based biopharmaceutical company that develops, manufactures, and commercializes rare disease therapies (Cortrophin Gel, ILUVIEN, YUTIQ) and over 100 generic prescription products, serving patients with rare conditions, physicians, and healthcare institutions.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Specialty Care Pharmaceuticals (HLAIAAAB)

akta.pro secondary industry

Generic Hospital & Institutional Products (HLAIABAL)

Keywords

• Generic pharmaceuticals
• Rare disease therapeutics
• Oral solid dose manufacturing
• Specialty pharmaceuticals
• Pharmaceutical contract manufacturing

Headquarters

HQ city

Baudette

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Operations, Personnel, Supply Chain, Marketing or Sales, Technology or R&D, Infrastructure

Revenue model

1. Rare Disease Products: Revenue from branded rare disease pharmaceuticals including Cortrophin Gel (repository corticotropin injection), ILUVIEN (fluocinolone acetonide intravitreal implant), and YUTIQ. This segment is the primary growth driver, expected to represent approximately 60% of 2026 revenues.
2. Generic Pharmaceuticals: Revenue from generic pharmaceutical products across multiple therapeutic categories including cardiovascular, central nervous system, anti-infective, and other treatments. Generics revenues were $105.4 million in Q1 2026, up 6.8% year-over-year.
3. Royalty Revenue: In March 2025, ANI acquired a 3.125% perpetual royalty obligation on YUTIQ and ILUVIEN net revenues from SWK Funding LLC for $17.25 million, generating ongoing royalty income.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

ANI Pharmaceuticals manufactures and markets generic prescription pharmaceutical products across multiple therapeutic categories (cardiovascular, CNS, anti-infective, pain management) in solid, liquid, and topical dosage forms, alongside branded rare disease therapeutics including Cortrophin Gel, ILUVIEN, and YUTIQ. The company operates U.S.-based manufacturing facilities in Baudette, MN and East Windsor, NJ with specialized containment capabilities for potent compounds, and distributes through wholesale, retail, specialty pharmacy, and direct hospital channels.

Product overview

ANI Pharmaceuticals is a diversified biopharmaceutical company focused on rare disease and generics. The company operates two main business segments: Rare Disease products (including Cortrophin Gel, Iluvien, and Yutiq) and Generics (over 100 generic pharmaceutical products). The Rare Disease segment, anchored by Cortrophin Gel which grew 76% year-over-year to $347 million in 2025, is expected to reach $618-658 million in 2026 and constitute roughly 60% of total revenues. The Generics segment provides a broad portfolio of tablets, capsules, oral solutions, topical products, and other dosage forms across therapeutic categories including cardiovascular, neurological, psychiatric, anti-infective, and pain management medications.

Differentiator

Problem solved

Functional benefit

Brands

• Cortrophin Gel: Purified Cortrophin Gel (repository corticotropin injection USP) - flagship rare disease therapy for multiple indications including MS, RA, and nephrotic syndrome
• ILUVIEN
• YUTIQ
• Carbamazepine Extended-Release Capsules (Carbatrol generic)
• Pimozide Tablets (Orap generic)

Products and services

• Cortrophin Gel Purified Cortrophin Gel (repository corticotropin injection USP) is ANI's flagship rare disease therapy approved for multiple indications including multiple sclerosis, rheumatoid arthritis, and nephrotic syndrome. Cortrophin Gel generated $347 million in 2025 revenue, up 76% year-over-year, and $75.1 million in Q1 2026 revenue, up 42.1% year-over-year.
• ILUVIEN ILUVIEN (fluocinolone acetonide intravitreal implant) is an FDA-approved intravitreal implant for diabetic macular edema and chronic non-infectious uveitis. Acquired as part of the Alimera Sciences acquisition in September 2024.
• YUTIQ YUTIQ (fluocinolone acetonide intravitreal implant) is an FDA-approved intravitreal implant for chronic non-infectious uveitis. ANI holds a 3.125% perpetual royalty obligation on YUTIQ net revenues.
• Generic Pharmaceuticals Portfolio Portfolio of over 100 generic pharmaceutical products across multiple therapeutic categories (cardiovascular, CNS, anti-infective, pain management) in various dosage forms including tablets, capsules, oral suspensions, topical solutions, enemas, injections, and powders. Generics segment generated $105.4 million in Q1 2026 revenue.
• Pimozide Tablets Generic version of Orap (pimozide) tablets in 1mg and 2mg doses, with 180-day Competitive Generic Therapy (CGT) exclusivity under FDA approval.
• Carbamazepine Extended-Release Capsules Generic version of Carbatrol (carbamazepine) extended-release capsules in 100mg, 200mg, and 300mg strengths for epilepsy treatment, targeting approximately $65 million in annual U.S. sales.
• Isosorbide Mononitrate Tablets Generic version of Monoket (isosorbide mononitrate) tablets USP in 10mg and 20mg dosages for angina treatment.

Quantifiable outcome

• Cortrophin Gel revenue of $347 million in 2025, up 76% year-over-year
• +3 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Two partnerships are on record, tiered minor and core.

• FutureVision Advisory CouncilminorStrategic or Co-development Partner · 1 December 2025ANI Pharmaceuticals established the FutureVision Advisory Council composed of retina and uveitis specialists to guide the strategic development of its ophthalmology and retina franchise. The council aims to support growth and innovation of ANI's products and new offerings.
• Alimera SciencescoreStrategic or Co-development Partner · 1 September 2024ANI Pharmaceuticals acquired Alimera Sciences in September 2024, acquiring the ILUVIEN and YUTIQ ophthalmology products. ILUVIEN is an FDA-approved intravitreal implant for diabetic macular edema and YUTIQ is approved for chronic non-infectious uveitis. The acquisition strengthened ANI's retina-focused business.

Scale indicators12 records

Recent moves6 records

Expansion highlights5 records

Regional players

• Sun Pharmaceutical Industries: Sun Pharma is one of the largest Indian generics manufacturers with a growing US specialty and generics business (including ophthalmology and dermatology). While headquartered outside the US, its US generics and specialty operations compete directly with ANI's portfolio.

Direct peers

• Mallinckrodt Pharmaceuticals: Mallinckrodt markets H.P. Acthar Gel, the principal branded competitor to ANI's Cortrophin Gel in the repository corticotropin category. Both companies target overlapping indications (MS, RA, nephrotic syndrome, infantile spasms) and compete for the same prescribers, payers, and specialty distribution channels.
• Amneal Pharmaceuticals: Amneal is a US-focused generics and specialty pharmaceutical manufacturer with a comparable hybrid model: a broad generics portfolio across multiple dosage forms alongside specialty branded products. Both companies compete in limited-competition generic launches and US-based manufacturing.
• Lannett Company: Lannett is a US generics manufacturer specializing in oral solid, topical, and specialty generic products with an emphasis on limited-competition molecules. It mirrors ANI's generics strategy and competes for similar customers and limited-competition opportunities.

Broad incumbents

• Endo International: Endo operates a specialty branded pharmaceuticals business (including rare disease-adjacent endocrine and neurology assets) alongside a substantial US generics franchise. Its diversified specialty/generic model and US manufacturing footprint are structurally comparable to ANI.
• Hikma Pharmaceuticals: Hikma is a multinational generic and specialty injectable manufacturer with a US generics and injectables business. Its branded specialty segment and broad generics portfolio overlap with ANI's hybrid model, especially in injectable and specialty pharmaceutical categories.
• Teva Pharmaceutical Industries: Teva is the world's largest generics manufacturer with a significant US generics presence and specialty pharma assets. While much larger and more diversified, its US generics business directly overlaps with ANI's portfolio across solid dose, liquids, and topicals.
• Sandoz (Novartis): Sandoz is a leading global generics and biosimilars business spun out of Novartis, with a substantial US generics footprint. Its scale and broad portfolio represent both a competitive threat and a benchmark for ANI's generics operations.
• Viatris: Viatris combines the legacy Mylan generics platform with the Upjohn branded specialty portfolio, producing a hybrid generics/specialty model with broad US market presence. Its portfolio breadth and US generics scale are comparable to ANI at a much larger size.

Emerging players

• Bausch + Lomb: Bausch + Lomb is a major ophthalmology company whose surgical and pharmaceutical retina products compete with ANI's ILUVIEN and YUTIQ franchise. It is relevant specifically as a comparator in ophthalmic intravitreal implants and retina-focused commercial infrastructure.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

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Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries2 records

Funding overview

Funding rounds4 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A4 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about ANI Pharmaceuticals