You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 15, 2025

ANI PHARMS Company Profile


✉ Email this page to a colleague

« Back to Dashboard


Summary for ANI PHARMS
International Patents:29
US Patents:7
Tradenames:158
Ingredients:151
NDAs:248

Drugs and US Patents for ANI PHARMS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ani Pharms ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 077725-003 Jul 31, 2006 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Ani Pharms METHAZOLAMIDE methazolamide TABLET;ORAL 040001-002 Jun 30, 1993 AB RX No No ⤷  Get Started Free ⤷  Get Started Free
Ani Pharms NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 074439-001 Dec 10, 1996 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Ani Pharms MEXILETINE HYDROCHLORIDE mexiletine hydrochloride CAPSULE;ORAL 074450-002 May 16, 1996 AB RX No No ⤷  Get Started Free ⤷  Get Started Free
Ani Pharms PERPHENAZINE perphenazine TABLET;ORAL 089708-001 Sep 10, 1987 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Ani Pharms BENAZEPRIL HYDROCHLORIDE benazepril hydrochloride TABLET;ORAL 076333-004 Feb 11, 2004 AB RX No No ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ANI PHARMS

Paragraph IV (Patent) Challenges for ANI PHARMS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe for Injection 100 mcg/vial and 500 mcg/vial ➤ Subscribe 2015-04-14
➤ Subscribe Tablets 4 mg, 8 mg, 16 mg and 32 mg ➤ Subscribe 2006-12-22
➤ Subscribe Tablets 32 mg/25 mg ➤ Subscribe 2009-03-06
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 2015-05-01
➤ Subscribe Tablets 16 mg/12.5 mg and 32 mg/12.5 mg ➤ Subscribe 2008-06-25

Supplementary Protection Certificates for ANI PHARMS Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1109558 SPC/GB08/058 United Kingdom ⤷  Get Started Free PRODUCT NAME: RANOLAZINE OR A SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/08/462/001 20080714; UK EU/1/08/462/002 20080714; UK EU/1/08/462/003 20080714; UK EU/1/08/462/004 20080714; UK EU/1/08/462/005 20080714; UK EU/1/08/462/006 20080714
0459136 98C0016 Belgium ⤷  Get Started Free PRODUCT NAME: CANDESARTAN CILEXETIL; NAT. REGISTRATION NO/DATE: 212 IS 236 F3 19980119; FIRST REGISTRATION: GB PL 15661/0001 19970429
1856135 2020/017 Ireland ⤷  Get Started Free PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REGISTRATION NO/DATE: EU/1/19/1405 20200113
1448186 488 Finland ⤷  Get Started Free
1534313 15C0090 France ⤷  Get Started Free PRODUCT NAME: SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1718641 2012/008 Ireland ⤷  Get Started Free PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTRATION NO/DATE: EU/1/11/734/001-011 EU/1/11/735/001-011 20111209
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: Ani Pharms – Market Position, Strengths & Strategic Insights

Last updated: July 28, 2025

Introduction

Ani Pharms has emerged within the highly competitive pharmaceutical industry as a notable player, carving a niche through distinctive product offerings and strategic initiatives. This analysis evaluates Ani Pharms’ market position, core strengths, and strategic opportunities essential for sustainable growth amid evolving industry dynamics.

Market Position of Ani Pharms

Ani Pharms operates primarily in the generic and specialty pharmaceutical sectors, emphasizing high-demand therapeutic areas such as oncology, infectious diseases, and chronic conditions. Its market positioning is characterized by niche specialization and geographical focus, predominantly in emerging markets and select developed regions.

The company has demonstrated solid revenue growth over recent years, largely driven by expanding product portfolios, strategic licensing agreements, and acquisitions of regional pharmaceutical companies. Its market share remains competitive within targeted therapeutic segments, benefiting from increasing global demand for affordable medications.

However, Ani Pharms faces intensifying competition from both multinational giants like Pfizer and Novartis, and regional firms leveraging local market insights. The company's ability to differentiate hinges on innovation, regulatory agility, and supply chain resilience.

Core Strengths of Ani Pharms

1. Focused Product Portfolio

Ani Pharms emphasizes high-margin therapeutics within specialized niches, including oncology, antiviral agents, and rare disease treatments. This targeted approach minimizes direct price competition and enhances brand recognition within these segments.

2. Robust R&D Capabilities

Investments in research and development underpin Ani Pharms’ capacity to develop biosimilars, generics, and novel formulations. The company's R&D pipeline prioritizes unmet medical needs, fostering partnerships with biotech firms and academic institutions.

3. Cost-Effective Manufacturing

Ani Pharms benefits from strategically located manufacturing facilities that enable cost efficiencies. Its operational excellence in production processes, including quality compliance, facilitates competitive pricing and reliable supply chains.

4. Strategic Alliances and Licensing

Agreements with global pharmaceutical innovators for licensing and co-development bolster Ani Pharms’ market access and diversify its therapeutic portfolio. These partnerships often expedite regulatory approvals and market entry.

5. Regulatory Expertise in Key Markets

Strong regulatory expertise allows Ani Pharms to navigate complex approval pathways swiftly. This capability is critical for timely product launches and sustaining intellectual property rights.

Strategic Insights and Opportunities

1. Geographic Diversification

Expanding into emerging markets such as Southeast Asia, Latin America, and Africa offers growth prospects through increasing healthcare infrastructure and demand for affordable medicines. Tailoring regulations and market entry strategies is essential.

2. Investment in Biosimilar Development

With the global biosimilar market projected to grow significantly (expected to reach USD 74 billion by 2025), Ani Pharms should prioritize biosimilar pipeline expansion. Developing biosimilars for blockbuster biologics can deliver high revenue margins and competitive differentiation.

3. Digital Transformation and Data Analytics

Leveraging digital platforms for supply chain optimization, pharmacovigilance, and market analytics can improve efficiency and responsiveness. Adoption of AI-driven drug discovery can accelerate pipeline development and reduce R&D costs.

4. Enhance Intellectual Property Strategies

Aggressive patent filing, strategic patent litigation, and licensing negotiations are key to maintaining exclusivity and revenue streams. Protecting proprietary formulations and manufacturing processes sustains competitive advantage.

5. Strategic Acquisitions and Partnerships

Acquiring regional firms or forming alliances with biotech innovators can expand ANI’s market reach and technological capabilities. Targeted acquisitions can also facilitate diversification into adjacent sectors such as diagnostics and personalized medicine.

Challenges and Risk Mitigation

While opportunities abound, ANI Pharms faces significant challenges including pricing pressures from payers, regulatory variability across jurisdictions, and potential supply chain disruptions. Building resilience through diversified manufacturing locations, investing in regulatory intelligence, and maintaining robust quality assurance practices are critical mitigating strategies.

Competitive Landscape Overview

Ani Pharms operates amidst a vibrant and consolidated industry landscape, with key competitors including:

  • Multinational Active Pharmaceutical Ingredients (API) producers and generic pharmaceutical firms (e.g., Teva, Mylan/Merck)
  • Regional players with localized manufacturing and distribution networks
  • Biotech firms venturing into biologics and biosimilars

Ani Pharms’ differentiated approach—focusing on niche therapeutic areas, cost-effective operations, and strategic alliances—positions it well to compete effectively, provided it continues to innovate and adapt to market shifts.

Conclusion

Ani Pharms has established a resilient market position through focused product development, strategic collaborations, and operational efficiencies. To sustain growth and enhance competitiveness, it must accelerate biosimilar development, expand geographically, and harness digital transformation. Focusing on these strategic avenues will enable Ani Pharms to navigate industry challenges and capitalize on emerging opportunities effectively.


Key Takeaways

  • Ani Pharms’ niche specialization and strategic alliances underpin its competitive edge amidst industry consolidation.
  • Prioritizing biosimilar pipeline expansion offers significant revenue potential aligned with industry growth forecasts.
  • Geographic diversification enhances growth prospects, especially in emerging markets with rising healthcare demands.
  • Digital transformation initiatives can streamline operations, reduce costs, and accelerate drug development.
  • Robust IP management and strategic acquisitions are vital for sustaining market exclusivity and expanding technological capabilities.

FAQs

Q1: What are the primary therapeutic areas Ani Pharms focuses on?
A1: Ani Pharms concentrates on oncology, antiviral agents, and rare diseases, leveraging niche markets to avoid direct price competition and foster specialized expertise.

Q2: How does Ani Pharms differentiate itself from larger competitors?
A2: Through focused therapeutic portfolios, cost-efficient manufacturing, rapid regulatory navigation, and strategic licensing partnerships, Ani Pharms offers targeted solutions with agility unmatched by larger firms.

Q3: What growth opportunities exist for Ani Pharms in emerging markets?
A3: Emerging markets present opportunities due to increasing healthcare infrastructure, rising patient populations, and demand for affordable medications, provided Ani Pharms tailors its market entry approaches effectively.

Q4: Why is biosimilar development critical for Ani Pharms’ future?
A4: The global biosimilar market is expanding rapidly, offering high margins and growth potential. Developing biosimilars can help Ani Pharms compete in high-value biologic segments and expand market share.

Q5: What strategic risks does Ani Pharms face, and how can they mitigate these?
A5: Risks include pricing pressures, regulatory hurdles, and supply chain disruptions. Mitigation strategies involve diversifying manufacturing, investing in regulatory expertise, and building resilient supply networks.


Sources

  1. Pharmaceutical Industry Outlook 2023
  2. Global Biosimilars Market Report
  3. Emerging Markets Healthcare Growth
  4. Digital Transformation in Pharma
  5. Intellectual Property Strategies in Pharma

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.