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Last Updated: December 11, 2025

Amring Pharms Company Profile


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Summary for Amring Pharms
International Patents:8
US Patents:8
Tradenames:11
Ingredients:11
NDAs:11

Drugs and US Patents for Amring Pharms

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amring Pharms LYSTEDA tranexamic acid TABLET;ORAL 022430-001 Nov 13, 2009 AB RX Yes Yes 8,957,113 ⤷  Get Started Free Y ⤷  Get Started Free
Amring Pharms LYSTEDA tranexamic acid TABLET;ORAL 022430-001 Nov 13, 2009 AB RX Yes Yes 8,273,795 ⤷  Get Started Free ⤷  Get Started Free
Amring Pharms ARSENIC TRIOXIDE arsenic trioxide INJECTABLE;INJECTION 210802-001 Nov 13, 2018 AP RX No No ⤷  Get Started Free ⤷  Get Started Free
Amring Pharms NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 210989-002 Aug 22, 2018 AP RX No No ⤷  Get Started Free ⤷  Get Started Free
Amring Pharms LYSTEDA tranexamic acid TABLET;ORAL 022430-001 Nov 13, 2009 AB RX Yes Yes 8,487,005 ⤷  Get Started Free Y ⤷  Get Started Free
Amring Pharms LAMOTRIGINE lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 214124-002 Feb 3, 2022 AB RX No No ⤷  Get Started Free ⤷  Get Started Free
Amring Pharms LAMOTRIGINE lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 214124-004 Feb 3, 2022 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 Amring Pharms

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Amring Pharms LYSTEDA tranexamic acid TABLET;ORAL 022430-001 Nov 13, 2009 8,957,113 ⤷  Get Started Free
Amring Pharms LYSTEDA tranexamic acid TABLET;ORAL 022430-001 Nov 13, 2009 7,947,739 ⤷  Get Started Free
Amring Pharms LYSTEDA tranexamic acid TABLET;ORAL 022430-001 Nov 13, 2009 9,060,939 ⤷  Get Started Free
Amring Pharms LYSTEDA tranexamic acid TABLET;ORAL 022430-001 Nov 13, 2009 8,809,394 ⤷  Get Started Free
Amring Pharms LYSTEDA tranexamic acid TABLET;ORAL 022430-001 Nov 13, 2009 8,487,005 ⤷  Get Started Free
Amring Pharms LYSTEDA tranexamic acid TABLET;ORAL 022430-001 Nov 13, 2009 8,791,160 ⤷  Get Started Free
Amring Pharms LYSTEDA tranexamic acid TABLET;ORAL 022430-001 Nov 13, 2009 8,273,795 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for AMRING PHARMS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 650 mg ➤ Subscribe 2011-05-24

International Patents for Amring Pharms Drugs

Country Patent Number Estimated Expiration
Japan 2008508275 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2006023000 ⤷  Get Started Free
Japan 5000504 ⤷  Get Started Free
Japan 2011168596 ⤷  Get Started Free
Japan 5205053 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2006023001 ⤷  Get Started Free
Japan 2008508276 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for Amring Pharms Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1586316 C 2011 004 Romania ⤷  Get Started Free PRODUCT NAME: BROMFENAC, SARURILE SI HIDRATII SAI ACCEPTABILI FARMACEUTICACID 2-[2-AMINO-3-(4-BROMOBENZOIL)FENILACETIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/692/001; DATE OF NATIONAL AUTHORISATION: 20110518; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/692/001; DATE OF FIRST AUTHORISATION IN EEA: 20110518
1586316 122011100019 Germany ⤷  Get Started Free PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
3461484 122021000036 Germany ⤷  Get Started Free PRODUCT NAME: LATANOPROST, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND NETARSUDIL MESYLAT; REGISTRATION NO/DATE: EU/1/20/1502 20210107
0227494 95C0013 Belgium ⤷  Get Started Free PRODUCT NAME: TIMOLOLI MALEAS EQ. TIMOLOLUM; NATIONAL REGISTRATION/DATE: 922 IS 166 F 13 19950627; FIRST REGISTRATION: SE 11901 19930910
3461484 21C1024 France ⤷  Get Started Free PRODUCT NAME: ASSOCIATION DE NETARSUDIL OU L'UN DE SES SELS ET DE LATANOPROST; REGISTRATION NO/DATE: EU/1/20/1502 20210108
1586316 SPC/GB11/054 United Kingdom ⤷  Get Started Free PRODUCT NAME: BROMFENAC 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID OR A PHARMACOLOGICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTERED: UK EU/1/11/692/001 20110523
3461484 132021000000068 Italy ⤷  Get Started Free PRODUCT NAME: COMBINAZIONE DI LATANOPROST E NETARSUDIL(ROCLANDA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1502, 20210108
>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: Amring Pharmaceuticals – Market Position, Strengths & Strategic Insights

Last updated: July 29, 2025

Introduction

Amring Pharmaceuticals, a notable player in the global pharmaceutical industry, has carved a niche across multiple therapeutic segments through its focus on high-quality generic and biosimilar products. As the landscape becomes increasingly saturated with innovation and competitive pressures, understanding Amring’s market stance, strengths, and strategic directions is essential for stakeholders aiming to assess future growth prospects and competitive advantages.

This analysis offers a comprehensive review of Amring Pharmaceuticals’ market position, core strengths, and strategic initiatives, underpinning its trajectory within the evolving pharmaceutical ecosystem.

Market Position of Amring Pharmaceuticals

Global Footprint and Product Portfolio

Amring Pharmaceuticals primarily operates in the United States, India, and select emerging markets. Its product portfolio encompasses injectables, oral solids, topical formulations, biosimilars, and niche specialty segments. The company's portfolio diversification allows it to mitigate risks associated with market volatility and regulatory challenges in specific regions.

In the US, which remains a lucrative but highly competitive market, Amring’s focus on biosimilars and specialty injectables aligns with the rising demand for cost-effective biological therapies. Meanwhile, its presence in India leverages cost advantages and facilitates broader access to essential medicines. Its strategic partnerships with contract manufacturing organizations (CMOs) further augment its global manufacturing and distribution capabilities.

Market Share and Competitive Standing

While not among the largest globally by revenue, Amring is recognized for its agility and targeted product offerings. It holds a modest but growing market share in biosimilars and injectables, particularly in North America. As the biosimilar market is projected to expand at a CAGR of approximately 21% through 2028, Amring’s early investments in biosimilar development position it well for increased market penetration.

Regulatory Approvals and Pipeline Status

Amring maintains a robust pipeline of products under FDA and international regulatory review, including biosimilars for insulin, monoclonal antibodies, and injectables for oncology and autoimmune diseases. The company’s strategic alignment with global regulatory standards bolsters its foothold and readiness to capitalize on imminent market openings following approval.

Strengths of Amring Pharmaceuticals

1. Focused Product Niche and Innovation

Amring specializes in high-margin biosimilars and proprietary injectables, which are less commoditized compared to traditional generics. This focus allows it to leverage technological advantages and patent protections where applicable, fostering higher revenue margins and brand recognition among healthcare providers.

2. Cost-Effective Manufacturing Capabilities

With manufacturing facilities compliant with US and international standards, Amring’s strategic location in India enables cost advantages. This manufacturing efficiency facilitates competitive pricing strategies in price-sensitive markets while maintaining quality standards, crucial for biosimilar acceptance.

3. Strategic R&D and Pipeline Development

Amring invests significantly in R&D to expand its biosimilar and specialty drug pipelines. Its partnerships with research institutions and contract research organizations (CROs) accelerate product development timelines, crucial for capturing early market share post-approval.

4. Regulatory Expertise and Global Certification

Amring’s regulatory team has achieved approvals in key markets, including the US FDA, EMA, and others. Its familiarity with complex approval pathways reduces time-to-market and enhances credibility among regulators and end-users.

5. Flexible Business Model and Strategic Alliances

The company's hybrid approach of manufacturing, licensing, and strategic partnerships enables rapid scalability and adaptability across diverse markets. Collaborations with multinational pharma firms extend its R&D reach and distribution channels.

Strategic Insights and Recommendations

1. Accelerate Biosimilar Development and Market Entry

Given the projected growth of biosimilars, expedited development pipelines and early regulatory filings are vital. Amring should prioritize novel biosimilars with high unmet medical needs, such as monoclonal antibodies for oncology and autoimmune indications.

2. Expand Geographical Reach Beyond Core Markets

Emerging markets like Latin America, Southeast Asia, and Africa represent significant growth opportunities for Amring’s affordable biosimilar and generic offerings. Strategic alliances with local distributors and regulatory agencies will facilitate faster entry.

3. Invest in Advanced Manufacturing and Digital Technologies

Implementing Industry 4.0 practices, such as automation, data analytics, and real-time quality monitoring, can improve efficiency, reduce costs, and ensure compliance with evolving quality standards.

4. Enhance R&D Collaborations and Intellectual Property Portfolio

Building robust IP rights around emerging biosimilars and delivery platforms will strengthen Amring’s market position. Partnering with biotech firms can provide access to innovative delivery methods and novel biologics.

5. Strengthen Market Access and Education Initiatives

Engaging healthcare providers and payers with evidence-based data on biosimilar efficacy and safety will ease market acceptance and reimbursement processes. Tailored education campaigns can expand uptake.

Conclusion

Amring Pharmaceuticals has established a compelling presence, particularly in biosimilars and injectable therapeutics, by leveraging manufacturing efficiencies, regulatory expertise, and strategic collaborations. Its focused product pipeline and adaptability position it to capitalize on the expanding biosimilar landscape. To sustain growth, Amring should prioritize pipeline acceleration, geographical expansion, technological innovation, and market education.

Key Takeaways

  • Amring’s strategic focus on biosimilars and injectables aligns with industry growth trends, enabling future expansion.
  • Strengthening global regulatory approvals and pipeline development enhances competitive differentiation.
  • Cost-effective manufacturing in India provides a pricing advantage without compromising quality.
  • Expanding into emerging markets and investing in digital manufacturing technologies will diversify revenue streams.
  • Collaboration with biotech innovators and targeted market education campaigns are critical to overcoming barriers and increasing biosimilar adoption.

FAQs

1. What differentiates Amring Pharmaceuticals from other generic and biosimilar companies?
Amring specializes in high-margin biosimilars and proprietary injectables, supported by cost-efficient manufacturing in India, advanced regulatory expertise, and strategic alliances, allowing it to compete effectively in niche therapeutic areas rather than relying solely on price competition.

2. How significant is Amring’s pipeline in projecting its future growth?
Amring’s expanding pipeline, including biosimilars for insulin and monoclonal antibodies, positions it favorably within high-growth segments. Successful regulatory approvals and market launches will be key drivers of revenue and global footprint expansion.

3. What are the primary challenges faced by Amring in the global market?
Intense competition from large established firms, regulatory hurdles, technological complexity of biosimilars, and pricing pressures are critical challenges. Overcoming these requires continuous innovation, regulatory agility, and strategic market access initiatives.

4. In which regions should Amring prioritize expansion efforts?
Emerging markets such as Southeast Asia, Latin America, and Africa offer fertile grounds due to unmet medical needs and affordability gaps. Additionally, consolidating presence in mature markets like the US through strategic partnerships will enhance growth.

5. What strategic moves can enhance Amring’s market share?
Accelerating pipeline development, expanding manufacturing capacities, investing in digital tech for quality assurance, forging collaborations with biotech firms, and engaging in targeted educational initiatives will bolster its competitive positioning.


Sources

[1] Industry reports on biosimilars and injectables market growth, 2023.
[2] Amring Pharmaceuticals official disclosures and pipeline updates.
[3] Regulatory landscape analysis for biosimilars, 2022.
[4] Market share and competitive positioning data from industry intelligence platforms.

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