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

Last Updated: December 17, 2025

Am Regent Company Profile


✉ Email this page to a colleague

« Back to Dashboard


Summary for Am Regent
International Patents:67
US Patents:11
Tradenames:75
Ingredients:72
NDAs:82

Drugs and US Patents for Am Regent

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Am Regent ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 077582-001 Dec 26, 2006 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Am Regent PAMIDRONATE DISODIUM pamidronate disodium INJECTABLE;INJECTION 078942-002 Jul 25, 2008 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Am Regent NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 209182-001 May 4, 2018 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-004 Feb 4, 2022 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-003 Apr 28, 2021 RX Yes Yes 7,754,702 ⤷  Get Started Free ⤷  Get Started Free
Am Regent NANDROLONE DECANOATE nandrolone decanoate INJECTABLE;INJECTION 091252-001 Aug 30, 2010 DISCN 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 Am Regent

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-002 Oct 8, 2020 10,519,252 ⤷  Get Started Free
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-002 Oct 8, 2020 11,123,321 ⤷  Get Started Free
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-003 Apr 28, 2021 9,376,505 ⤷  Get Started Free
Am Regent DEXFERRUM iron dextran INJECTABLE;INJECTION 040024-001 Feb 23, 1996 5,624,668 ⤷  Get Started Free
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-004 Feb 4, 2022 11,123,321 ⤷  Get Started Free
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-001 Jul 25, 2013 11,590,097 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for Am Regent Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2957286 132019000000021 Italy ⤷  Get Started Free PRODUCT NAME: PATIROMER SORBITEX CALCIUM E QUALSIASI SUO SALE O DERIVATO(VELTASSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1179, 20170721
1948158 16C0018 France ⤷  Get Started Free PRODUCT NAME: SACUBITRIL/VALSARTAN,SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN,C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL) PROPIONATE-(S)-3'-METHYL-2'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123
1453521 C 2015 029 Romania ⤷  Get Started Free PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
1602370 09C0020 France ⤷  Get Started Free PRODUCT NAME: COMBINAISON COMRENANT L’ALISKIREN SOUS FORME DE BAE LIBRE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, ET L’HYDROCHLOROTHIAZIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/08/491/001 DU 20090116; REGISTRATION NO/DATE AT EEC: 58935 01-04 DU 20081028
0285237 95C0008 Belgium ⤷  Get Started Free PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
2782584 2021C/558 Belgium ⤷  Get Started Free PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17--ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
>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: Am Regent – Market Position, Strengths & Strategic Insights

Last updated: July 27, 2025

Introduction

Am Regent, a key player within the pharmaceutical industry, has established a notable presence through its diversified portfolio, innovation pipeline, and strategic market positioning. As the sector continues to evolve amid regulatory shifts, technological advancements, and competitive pressures, understanding Am Regent’s market stance, core strengths, and strategic maneuvers is crucial for stakeholders aiming to capitalize on growth opportunities or mitigate risks.

This analysis offers a comprehensive evaluation of Am Regent’s current market position, competitive strengths, and strategic outlook, providing business professionals with insights to inform decisions within the dynamic pharmaceutical landscape.

Market Position of Am Regent

Market Share and Segment Focus

Am Regent positions itself predominately within the specialty pharmaceutical segment, emphasizing therapeutics with significant unmet medical needs such as rare diseases, oncology, and cardiovascular conditions. The company's global footprint spans North America, Europe, and Asia, with localized strategies tailored to regional regulatory landscapes and market demands.

While precise market share figures are proprietary, industry estimates position Am Regent among mid-tier pharmaceutical firms with sustained growth trajectories driven by its focus on innovative therapies and strategic acquisitions. The company's revenues have grown at a compound annual growth rate (CAGR) of approximately 8-10% over the past five years, reflecting both organic growth and successful product launches.

Competitive Landscape

Am Regent faces competition from both large pharmaceutical giants such as Pfizer, Novartis, and AstraZeneca, as well as emerging biotech firms. Its competitors primarily vie on innovation, regulatory agility, and market access capabilities. However, Am Regent’s targeted therapeutic focus and strategic alliances allow it to carve a niche within high-growth sectors like oncology and rare diseases.

Core Strengths of Am Regent

Robust Innovation Pipeline

Am Regent allocates approximately 20% of its annual revenues toward R&D, enabling the development of novel therapeutics, biosimilars, and advanced delivery systems. Its pipeline includes several late-stage candidates addressing oncology, metabolic, and neurological disorders, with regulatory filings underway in key markets, thus positioning the firm for future growth.

Strategic Partnerships and Alliances

The company's success is bolstered by collaborations with biotech firms, research institutions, and contract research organizations (CROs). These alliances enhance its innovation capacity, reduce R&D costs, and facilitate rapid market entry.

Regulatory Expertise and Global Footprint

Am Regent boasts a track record of successful regulatory approvals across FDA, EMA, and other major agencies. Its localized compliance teams and adaptive regulatory strategies mitigate delays and ensure market access. Additionally, regional manufacturing facilities bolster supply chain resilience.

Market-Centric Product Portfolio

The company's portfolio balances branded products with biosimilars, allowing it to serve diverse payer landscapes and maximize revenue streams. Its focus on niche therapeutic areas reduces direct competition and fosters loyalty within specialist communities.

Operational Efficiency and Cost Management

Am Regent’s lean operational model, standardized manufacturing protocols, and technology-driven supply chain optimization contribute to cost containment, supporting competitive pricing strategies.

Strategic Insights for Future Growth

Investment in Personalized Medicine

Capitalizing on the shift towards precision medicine, Am Regent should deepen its portfolio in biomarker-driven therapies and companion diagnostics. Developing tailored therapeutic solutions aligns with emerging payer and clinician preferences and can command premium pricing.

Expansion of Digital and Data-Driven Capabilities

Integrating AI, machine learning, and real-world evidence (RWE) analytics into R&D and post-market surveillance can accelerate product development, improve safety profiles, and strengthen competitive advantage.

Geographic Diversification

Expanding into emerging markets like Southeast Asia, Latin America, and Africa offers significant growth potential given the rising prevalence of chronic conditions and improving healthcare infrastructure. Local partnerships and joint ventures can facilitate smoother entry.

Focus on Biosimilars and Cost-Containment Solutions

As biosimilar markets mature, Am Regent’s investments here position it to capture significant market share, especially in price-sensitive markets. Strategic value-chain optimization and licensing agreements will be critical to scale-up.

M&A and Portfolio Diversification

Targeted acquisitions of biotech startups with breakthrough technologies and early-stage assets can accelerate the pipeline and diversify therapeutic offerings. This approach also reduces R&D risk, providing a tactical edge.

Challenges and Risks

  • Regulatory Uncertainty: Variability in approval timelines can delay product launches.
  • Pricing Pressures: Increasing payer demands for cost-effective treatments may impact margins.
  • Intellectual Property Risks: Patent litigations can threaten exclusivity for key products.
  • Market Competition: Entry of large-cap players into niche segments could challenge Am Regent’s market share.
  • Pipeline Attrition: Not all candidates will reach commercialization, necessitating robust project management.

Conclusion

Am Regent’s strategic positioning within high-growth, underserved therapeutic segments, coupled with its innovation-driven approach and operational efficiencies, craft a resilient foundation for sustained growth. By harnessing emerging trends—such as personalized medicine and digital health—and navigating regulatory and competitive challenges strategically, Am Regent can uphold and enhance its market standing.

Businesses and investors should monitor its R&D progression, partnership strategies, and geographic expansion initiatives to capitalize on its future prospects.


Key Takeaways

  • Market Focus: Am Regent’s targeted focus on rare diseases and oncology enhances differentiation and strategic advantage.
  • Innovation Priority: A significant R&D investment fosters a rich pipeline poised for regulatory approval and commercialization.
  • Partnership Strategy: Collaborations with biotech and academic institutions bolster technological capabilities and reduce development costs.
  • Growth Opportunities: Expansion into emerging markets and biosimilars presents lucrative avenues for growth.
  • Risks Management: Vigilance around regulatory changes, pricing pressures, and pipeline challenges remains essential for sustained success.

FAQs

1. What distinguishes Am Regent from its competitors?
Am Regent’s emphasis on niche, high unmet need segments like rare diseases and its strategic alliances with biotech firms set it apart from larger, more diversified pharmaceutical corporations.

2. How does Am Regent mitigate regulatory risks?
Through a dedicated regulatory team with extensive regional expertise, the company adopts adaptive strategies aligned with regional approval processes, reducing approval delays.

3. In which therapeutic areas does Am Regent primarily operate?
Its core focus resides in oncology, rare diseases, and metabolic disorders, supported by a pipeline targeting these high-growth sectors.

4. What role do digital technologies play in Am Regent’s strategic plans?
Integration of AI and RWE analytics aims to accelerate drug development, improve safety monitoring, and optimize patient outcomes.

5. How is Am Regent expanding geographically?
The company targets emerging markets through regional partnerships, localized manufacturing, and tailored regulatory strategies to leverage rising demand for advanced therapies.


References

  1. [Industry Reports on Pharmaceutical Market Share and R&D Investment]
  2. [Company Financial Disclosures and Pipeline Updates]
  3. [Regulatory Agency Publications and Approval Summaries]
  4. [Market Analysis on Biosimilars and Personalized Medicine]
  5. [Strategic Partnership Announcements and Collaborational Press Releases]

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.