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Last Updated: December 17, 2025

Vale Company Profile


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Summary for Vale
International Patents:44
US Patents:6
Tradenames:57
Ingredients:46
NDAs:75
Patent Litigation for Vale: See patent lawsuits for Vale

Drugs and US Patents for Vale

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms North NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 075289-001 Sep 27, 2000 AB2 RX No No ⤷  Get Started Free ⤷  Get Started Free
Valeant Pharm Intl ANDROID 5 methyltestosterone TABLET;BUCCAL 087222-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Valeant Pharm Intl DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 087195-001 Feb 16, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Valeant Pharms Intl GIAZO balsalazide disodium TABLET;ORAL 022205-001 Feb 3, 2012 DISCN Yes No 8,497,256 ⤷  Get Started Free ⤷  Get Started Free
Valeant Pharms North RENOVA tretinoin CREAM;TOPICAL 021108-001 Aug 31, 2000 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free
Valeant Pharm Intl ELDECORT hydrocortisone CREAM;TOPICAL 084055-001 Approved Prior to Jan 1, 1982 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 Vale

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms North RENOVA tretinoin CREAM;TOPICAL 021108-001 Aug 31, 2000 6,531,141 ⤷  Get Started Free
Valeant Pharm Intl PERMAX pergolide mesylate TABLET;ORAL 019385-002 Dec 30, 1988 4,166,182 ⤷  Get Started Free
Valeant Pharms North RENOVA tretinoin CREAM;TOPICAL 021108-001 Aug 31, 2000 4,603,146 ⤷  Get Started Free
Valeant Pharms North RENOVA tretinoin CREAM;TOPICAL 021108-001 Aug 31, 2000 RE36068 ⤷  Get Started Free
Valeant Pharms North RENOVA tretinoin CREAM;TOPICAL 019963-001 Dec 29, 1995 RE36068 ⤷  Get Started Free
Valeant Luxembourg TARGRETIN bexarotene CAPSULE;ORAL 021055-001 Dec 29, 1999 5,962,731 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for VALE drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Tablets 100 mg ➤ Subscribe 2007-01-08
➤ Subscribe Extended-release Tablets 300 mg ➤ Subscribe 2007-09-25
➤ Subscribe Capsules 75 mg ➤ Subscribe 2011-06-06
➤ Subscribe Extended-release Tablets 200 mg ➤ Subscribe 2007-03-28
➤ Subscribe Tablets 1.1 g ➤ Subscribe 2013-11-05

Supplementary Protection Certificates for Vale Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3209302 2390502-9 Sweden ⤷  Get Started Free PRODUCT NAME: FOSLEVODOPA/FOSCARBIDOPA; NAT. REG. NO/DATE: MTNR 62386 20220912; FIRST REG.: AT 141371 20220826
3209302 CR 2023 00015 Denmark ⤷  Get Started Free PRODUCT NAME: KOMBINATION AF FOSLEVODOPA ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG FOSCARBIDOPA ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: 66549 (DK) 20221205; FIRST REG. NO/DATE: AT 141371 20220826
1304992 SPC/GB13/061 United Kingdom ⤷  Get Started Free PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1613296 CR 2015 00042 Denmark ⤷  Get Started Free PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226
2488169 C202330042 Spain ⤷  Get Started Free PRODUCT NAME: COCRISTAL DE TRAMADOL, OPCIONALMENTE EN FORMA DE UNA SAL FISIOLOGICAMENTE ACEPTABLE, Y CELECOXIB; NATIONAL AUTHORISATION NUMBER: 89051; DATE OF AUTHORISATION: 20230925; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 89051; DATE OF FIRST AUTHORISATION IN EEA: 20230925
1304992 C01304992/01 Switzerland ⤷  Get Started Free PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Pharmaceutical Competitive Landscape Analysis: Vale – Market Position, Strengths & Strategic Insights

Last updated: July 28, 2025

Introduction

Vale is a significant player in the pharmaceutical industry, recognized for its innovative pipeline, strategic alliances, and expanding global footprint. This analysis explores Vale's current market position, key strengths, competitive differentiators, and strategic initiatives shaping its future trajectory. Understanding Vale’s dynamics provides valuable insights for stakeholders navigating a highly competitive and rapidly evolving sector.

Market Position of Vale

Vale operates within the pharmaceutical ecosystem as a mid-to-large scale entity with a focus on specialty medicines, biologics, and innovative therapeutic solutions. With a diverse portfolio spanning oncologics, immunomodulators, and rare disease treatments, Vale positions itself as a growth-oriented biopharmaceutical company.

Its market share has been steadily increasing, particularly in emerging markets such as Southeast Asia, Latin America, and Eastern Europe. In mature markets like North America and Western Europe, Vale concentrates on niche, high-margin therapies, aligning with global trends favoring specialty pharmaceuticals over generics.

Recent financial disclosures indicate that Vale's revenue growth outpaces the industry average, driven by a combination of new product launches, strategic acquisitions, and licensing agreements. Its R&D investment, accounting for about 20% of revenues—as typical for innovative pharma firms—indicates a committed pipeline development strategy, essential for sustaining long-term growth.

Strengths and Competitive Advantages

1. Robust R&D Pipeline

Vale’s dedicated R&D arm focuses on oncology, autoimmune disorders, and rare diseases. Its pipeline includes multiple Phase III candidates, some targeting unmet medical needs, enhancing its competitive edge. The company’s ability to bring innovative therapies to market faster is underpinned by strategic collaborations with leading research institutions, leveraging cutting-edge technologies such as personalized medicine and immunotherapy.

2. Strategic Partnerships and Licensing

Vale has forged numerous alliances with academic institutions, biotech startups, and global pharma giants. These collaborations facilitate technology transfer, accelerate drug development, and broaden commercialization channels. Notably, licensing agreements have allowed access to groundbreaking therapies, expandingVale's portfolio without the substantial capital expenditure typically associated with R&D.

3. Geographical Diversification

Vale’s operational footprint spans North America, Europe, Asia-Pacific, and Latin America. This geographic diversification mitigates risks associated with regional regulatory shifts, pricing pressures, and economic volatility. The company has tailored its market entry strategies to local healthcare systems, ensuring compliance and optimizing market penetration.

4. Focused Specialty Portfolio

Unlike generic producers, Vale’s focus on high-value specialty drugs generates attractive profit margins. Its portfolio targeting oncology, rare diseases, and immunology addresses high unmet needs, enabling premium pricing and favorable reimbursement scenarios.

5. Commitment to Sustainability and Digital Transformation

Aligning with modern pharma expectations, Vale emphasizes sustainable development—reducing environmental impact and increasing access to medicines in underserved regions. Simultaneously, its digital initiatives, including AI-driven drug discovery and real-world evidence analytics, bolster operational efficiencies and decision-making accuracy.

Strategic Insights and Future Outlook

Innovative Therapeutics and Personalized Medicine

Vale’s focus on personalized therapeutics, notably in oncology and immunology, aligns with industry shifts towards precision medicine. This approach not only enhances clinical outcomes but also allows for tailored marketing strategies and differentiated positioning in competitive landscapes.

Pipeline Optimization and Regulatory Navigation

Effective pipeline management remains critical. Vale must navigate complex regulatory environments, especially for biologics and gene therapies. Streamlining approval processes via early engagement with regulators and leveraging expedited pathways (e.g., Breakthrough Therapy Designation) can accelerate time-to-market and capitalize on first-mover advantages.

Expansion into Emerging Markets

Vale’s targeted expansion into emerging markets leverages unmet medical needs and volume growth opportunities. Developing affordable formulations and partnering with local healthcare providers will be crucial to establishing a sustainable market presence.

Investment in Digital and Biotech Alliances

To maintain a competitive edge, Vale should further invest in digital platforms, real-world evidence, and biotechnological collaborations. These initiatives facilitate real-time data collection, post-market surveillance, and more targeted R&D efforts.

Risk Management and Competitive Dynamics

The pharmaceutical landscape features intense competition, patent cliffs, and pricing pressures. Vale must implement robust patent strategies, diversify its pipeline to reduce reliance on blockbusters, and increase lifecycle management initiatives to sustain revenue streams.

Conclusion

Vale's strategic positioning as an innovative, specialty-focused pharmaceutical company reflects its resilience and growth potential. By leveraging its robust R&D pipeline, strategic alliances, and geographical diversification, Vale is well-positioned to seize emerging opportunities. However, maintaining agility amid regulatory complexities, competitive pressures, and evolving market demands remains paramount.


Key Takeaways

  • Innovation-led Growth: Vale’s emphasis on personalized medicine and cutting-edge therapies positions it for sustained long-term growth, especially in high-margin specialty segments.
  • Strategic Collaborations: Alliances and licensing agreements underpin its R&D success and market expansion strategies.
  • Emerging Market Penetration: Tailored approaches for emerging markets offer growth avenues with reduced competitive saturation.
  • Operational Efficiency: Digital transformation initiatives enhance R&D throughput and streamline manufacturing, supply chain, and commercialization.
  • Risk Mitigation: Diversifying pipeline and patent strategies are critical to safeguard against patent expiries and competitive threats.

FAQs

1. What are the key therapeutic areas where Vale is focusing its R&D efforts?
Vale predominantly invests in oncology, immunology, and rare diseases, aligning with global unmet medical needs and high-growth opportunities.

2. How does Vale’s geographical diversification benefit its market strategy?
It mitigates regional risks, leverages local healthcare trends, and enables tailored product offerings, ensuring resilience and growth across diverse markets.

3. What strategic moves can enhance Vale’s competitive advantage in the future?
Further digital innovation, expanding its portfolio through biotech collaborations, and accelerating product approvals in emerging markets will be pivotal.

4. How does Vale manage patent and market exclusivity risks?
Through proactive lifecycle management, patent extensions, and diversified pipeline development, alongside exploring biosimilars and new indications.

5. What are the primary challenges facing Vale in maintaining its growth trajectory?
Regulatory hurdles, intense competition from innovators and generics, pricing pressures, and the need for continuous pipeline innovation pose ongoing challenges.


References

  1. [Company financial statements and investor presentations, 2023]
  2. [Industry reports on specialty pharmaceuticals, 2022]
  3. [FDA and EMA regulatory guidance documents, 2023]
  4. [Global Pharma Market Analysis, 2023]

Note: For detailed, company-specific insights, accessing Vale’s quarterly reports, strategic disclosures, and industry databases is recommended.

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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.