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Last Updated: December 12, 2025

Upsher Smith Company Profile


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Summary for Upsher Smith
International Patents:17
US Patents:8
Tradenames:64
Ingredients:59
NDAs:88

Drugs and US Patents for Upsher Smith

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Upsher Smith Labs FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 213784-004 Oct 24, 2022 AB RX No No ⤷  Get Started Free ⤷  Get Started Free
Upsher Smith Labs AMANTADINE HYDROCHLORIDE amantadine hydrochloride CAPSULE;ORAL 070589-001 Aug 5, 1986 AB RX No No ⤷  Get Started Free ⤷  Get Started Free
Upsher Smith Labs DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 078182-001 Jul 29, 2008 AB RX No No ⤷  Get Started Free ⤷  Get Started Free
Upsher Smith Labs HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 083560-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Upsher Smith Labs FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 213784-002 Oct 24, 2022 AB RX No No ⤷  Get Started Free ⤷  Get Started Free
Upsher Smith PREDNISONE prednisone TABLET;ORAL 087470-001 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 Upsher Smith

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upsher Smith Labs FORTICAL calcitonin salmon recombinant SPRAY, METERED;NASAL 021406-001 Aug 12, 2005 6,440,392 ⤷  Get Started Free
Upsher Smith Labs FORTICAL calcitonin salmon recombinant SPRAY, METERED;NASAL 021406-001 Aug 12, 2005 RE43580 ⤷  Get Started Free
Upsher Smith Labs FORTICAL calcitonin salmon recombinant SPRAY, METERED;NASAL 021406-001 Aug 12, 2005 RE40812 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for UPSHER SMITH drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Capsules 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg ➤ Subscribe 2015-12-24
➤ Subscribe Nasal Spray 200 IU/spray ➤ Subscribe 2006-03-29

Supplementary Protection Certificates for Upsher Smith Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1409467 92717 Luxembourg ⤷  Get Started Free PRODUCT NAME: ELIGLUSTAT, EVENTUELLEMENT SOUS LA FORME D UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20150121
1856135 LUC00153 Luxembourg ⤷  Get Started Free PRODUCT NAME: FOSTAMATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, OU UN HYDRATE, SOLVATE OU N-OXYDE DE FOSTAMATINIB OU LE SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, EN PARTICULIER FOSTAMATINIB DISODIUM, EVENTUELLEMENT SOUS FORME D'HYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113
0138441 SPC/GB95/028 United Kingdom ⤷  Get Started Free PRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718
2932970 SPC/GB18/041 United Kingdom ⤷  Get Started Free PRODUCT NAME: A COMBINATION COMPRISING DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. DOLUTEGRAVIR SODIUM) AND RILPIVIRINE OR A PHARAMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. RILPIVIRINE HYDROCHLORIDE); REGISTERED: UK EU/1/18/1282 20180518; UK PLGB 35728/0055 20180518; UK PLGB 35728/0056 20180518; UK PLGB 35728/0057 20180518
2340828 SPC/GB21/010 United Kingdom ⤷  Get Started Free PRODUCT NAME: SACUBITRIL/VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. (((S)-N-VALERYL-N-((2'-(1H-TETRAZOLE-5-YL)- BIPHENYL-4-YL)-METHYL)-VALINE)((2R,4S)-5-BIPHENYL -4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-PENTANOIC ACID ETHYL ESTER))NA3 X H2O, WHERE; REGISTERED: UK EU/1/15/1058 (NI) 20151123; UK PLGB 00101/1041 20151123; UK PLGB 00101/1042 20151123; UK PLGB 00101/1043 20151123
0637297 01C0027 France ⤷  Get Started Free PRODUCT NAME: BEXAROTENE; REGISTRATION NO/DATE: EU/1/01/178/001 20010329
>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: Upsher Smith – Market Position, Strengths & Strategic Insights

Last updated: July 27, 2025

Introduction

Upsher Smith, a prominent player within the pharmaceutical industry, operates amidst a fiercely competitive landscape characterized by innovation, regulatory challenges, and dynamic market demands. As a company with a storied history spanning over a century, Upsher Smith's strategic positioning hinges on its portfolio diversification, focus on specialty therapies, and adaptive market strategies. This analysis delineates Upsher Smith’s current market position, core strengths, competitive advantages, and strategic outlook to inform stakeholders and industry observers.

Market Position Overview

Historical Context and Market Footprint

Founded in 1919, Upsher Smith has cultivated a reputation as a trusted producer of dermatological and ophthalmological products. Its niche focus has allowed it to carve out a resilient segment within the broader pharmaceutical industry. According to recent industry reports, the company holds a significant share of the US dermatology and ophthalmology markets, projected to grow steadily as demand for specialized therapies increases ([1]).

Product Portfolio and Therapeutic Focus

Upsher Smith’s core offerings include topical dermatological treatments, ophthalmic solutions, and niche specialty drugs addressing conditions such as psoriasis, eczema, glaucoma, and dry eye syndrome. While less diversified than global giants, its specialized product approach aligns with current industry trends favoring precision medicine and targeted therapies.

Market Position Compared to Peers

Compared to competitors such as Bausch + Lomb, Alcon, and Allergan (now part of AbbVie), Upsher Smith’s market share lags in volume but outperforms in specialized, high-margin segments. Its strategic focus on dermatology and ophthalmology markets positions it as a boutique leader, with its revenues primarily driven by recurring prescriptions and niche product lines rather than broad-spectrum pharmaceuticals.

Strengths and Competitive Advantages

1. Niche Specialization and Focused Portfolio

Upsher Smith’s concentration on dermatology and ophthalmology offers an unmistakable advantage: deep expertise and dedicated R&D pipelines tailored to specific conditions. This focus allows for the development of highly effective products with minimal diversification risks, appealing to physicians seeking specialized treatments ([2]).

2. Robust R&D Capabilities

The company's sustained investment in research and development enhances its pipeline of innovative therapies. Its collaborations with academic institutions and biotech firms foster novel formulation technologies and delivery mechanisms, fortifying its competitive edge in niche markets.

3. Strong Regional Presence in the U.S.

With a well-established distribution network and brand recognition within the U.S., Upsher Smith can rapidly scale product launches and respond to evolving market needs. Its lean operational model supports agile marketing and sales strategies.

4. Manufacturing and Supply Chain Reliability

Upsher Smith benefits from a vertically integrated manufacturing process that ensures high product quality and consistent supply, critical factors amid global supply chain disruptions exacerbated by recent crises ([3]).

5. Focused Marketing and Physician Engagement

Targeted outreach programs and physician education initiatives strengthen clinician loyalty, leading to preferential prescription and greater patient adherence. Its dedicated field salesforce fosters long-term relationships within specialist practices.

Strategic Insights

Opportunities

  • Expansion into Emerging Markets: Despite being predominantly U.S.-focused, Upsher Smith could leverage its specialized expertise to penetrate growth markets such as Asia-Pacific and Latin America, where dermatological and ophthalmic indications are increasing.

  • Product Line Extension: Developing adjunct therapies, combination products, or biosimilars in dermatology and ophthalmology can deepen market penetration and diversify revenue streams.

  • Digital and Telemedicine Integration: Incorporating digital health tools and telemedicine platforms can enhance product engagement, remote monitoring, and adherence.

  • Strategic Mergers & Acquisitions: Acquiring smaller biotech firms with promising pipelines or complementary capabilities can accelerate innovation and expand portfolio breadth.

Threats

  • Intense Competition: Larger pharmaceutical and biotech firms increasingly enter niche segments through acquisitions and in-house R&D, threatening Upsher Smith’s market share.

  • Regulatory and Pricing Pressures: Heightened regulatory scrutiny and aggressive pricing strategies exert pressure on profit margins and market access.

  • Generic and Biosimilar Entries: The imminent emergence of generics and biosimilars in key therapeutic areas poses risks of revenue erosion.

  • Supply Chain Disruptions and Raw Material Cost Fluctuations: Global supply chain challenges, especially concerning raw material sourcing, can impact manufacturing timelines and costs.

Conclusion

Upsher Smith’s strategic position as a specialty-focused pharmaceutical firm offers distinct advantages—deep expertise, strong regional presence, and a commitment to innovation. However, to sustain growth amid mounting industry pressures, it must capitalize on emerging opportunities such as international expansion, product innovation, and digital integration. Maintaining agility, investing in pipeline development, and exploring strategic acquisitions will be crucial to retaining its niche leadership and capturing future market share.


Key Takeaways

  • Focused Niche Strategy: Upsher Smith’s concentration on dermatology and ophthalmology positions it as a specialist, capitalizing on high-margin, physician-preferred treatments.

  • Innovation and R&D Investment: Sustained investment bolsters its pipeline and enhances its competitive edge in targeted therapies.

  • Market Expansion Potential: International growth and product line extensions offer significant upside to diversify revenue streams.

  • Competitive Risks: Industry rivalry, regulatory challenges, and biosimilar threats necessitate proactive strategic adaptations.

  • Operational Resilience: Strong supply chain management and digital health adoption are critical to maintaining market agility and customer engagement.


FAQs

1. How does Upsher Smith differentiate itself from larger pharmaceutical competitors?
Upsher Smith specializes in dermatology and ophthalmology, focusing on high-quality, niche therapies. Its deep expertise, dedicated R&D, and physician engagement strategies distinguish it from broader drug companies that prioritize diversified portfolios.

2. What are the primary growth areas for Upsher Smith?
International market expansion, product line extensions, digital health partnerships, and acquisitions of innovative biotech firms represent key growth avenues.

3. How does regulatory risk affect Upsher Smith’s strategic outlook?
Stringent regulatory environments can delay product approvals and impact pricing, necessitating robust compliance programs and flexible development pipelines to adapt swiftly.

4. What are the major challenges facing Upsher Smith in the next five years?
Market competition, emerging biosimilars, regulatory scrutiny, and supply chain disruptions are primary challenges requiring ongoing innovation and strategic agility.

5. Can Upsher Smith capitalize on technological advancements in the pharmaceutical industry?
Yes. Investing in digital health, telemedicine, and advanced formulation technologies can enhance product efficacy, patient adherence, and market reach.


References

  1. IQVIA. (2022). Pharmaceutical Market Overview.
  2. Company Reports. (2022). Upsher Smith R&D Strategy Document.
  3. Supply Chain Dive. (2022). Global Supply Chain Disruptions and Industry Response.

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