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Last Updated: December 28, 2025

Upsher Smith Labs Company Profile


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Summary for Upsher Smith Labs
International Patents:17
US Patents:8
Tradenames:59
Ingredients:54
NDAs:80

Drugs and US Patents for Upsher Smith Labs

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 MORPHINE SULFATE morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 202104-004 Jun 3, 2013 RX No No ⤷  Get Started Free ⤷  Get Started Free
Upsher Smith Labs KLOR-CON M20 potassium chloride TABLET, EXTENDED RELEASE;ORAL 074726-001 Nov 20, 1998 AB1 RX No Yes ⤷  Get Started Free ⤷  Get Started Free
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-004 Mar 11, 2014 AB2 RX Yes No 8,652,527 ⤷  Get Started Free Y ⤷  Get Started Free
Upsher Smith Labs MYORISAN isotretinoin CAPSULE;ORAL 076485-001 Jan 19, 2012 AB1 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 Upsher Smith Labs

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

Supplementary Protection Certificates for Upsher Smith Labs Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0138441 SPC/GB95/028 United Kingdom ⤷  Get Started Free PRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718
2340828 LUC00195 Luxembourg ⤷  Get Started Free PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE DE SEL DE SODIUM SACUBITRIL VALSARTAN, C'EST-A-DIRE (((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-ESTER ETHYLIQUE D'ACIDE PENTANOIQUE))NA3 X H2O, DANS LEQUEL X EST 0 A 3; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
0780390 PA2004012 Lithuania ⤷  Get Started Free PRODUCT NAME: MOXIFLOXACINI HYDROCHLORIDUM (1-CIKLOPROPIL-6-FLUOR-__ 1,4-DIHIDRO-8-METOKSI-7-[(4AS, 7AS)-OKTAHIDRO-6H-PIROLO[3,4-B]PIRIDIN_-6-IL]-4-OKSO-3-CHINOLINKARBOKSIRûGðTIES HIDROCHLORIDAS)
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
>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 Labs – Market Position, Strengths & Strategic Insights

Last updated: July 28, 2025

Introduction

Upsher Smith Labs (USL), a prominent player within the pharmaceutical industry, has carved out a strategic niche through a blend of innovative product development and targeted market positioning. As competition intensifies amid evolving healthcare landscapes, understanding USL’s market stance, intrinsic strengths, and strategic maneuvers becomes essential for stakeholders. This analysis delves into the company’s market position, core competencies, competitive advantages, and future pathway within the pharmaceutical arena.

Market Position Overview

Founded in 1919 and headquartered in Tampa, Florida, Upsher Smith Labs has established a solid presence primarily in the neurologics and dermatologics sectors. The company’s portfolio includes a range of prescription medications focusing on neurology, pain management, and dermatological products, positioning it within specialized therapeutic areas.

USL ranks among mid-sized pharmaceutical firms in the United States, competing with industry giants like Pfizer, Johnson & Johnson, and Novartis. While its market share remains comparatively modest, its strategic focus on niche markets—such as anticonvulsants and dermatological drugs—facilitates a robust position in these segments. Notably, USL’s acquisition of key assets and alliances with contract manufacturing organizations (CMOs) bolster its production capabilities, ensuring a steady supply chain.

According to recent industry reports, USL’s revenue maintains a steady growth trajectory, driven by increasing demand for its neurology-focused portfolio and organic product pipeline expansion. The company's strategic marketing efforts and targeted physician outreach further consolidate its presence in specialized markets.

Core Strengths

1. Specialized Therapeutic Focus

USL’s concentration on niche therapeutic areas like epilepsy, neurology, and dermatology positions it uniquely against broad-spectrum pharmaceutical giants. This focus enables the company to tailor R&D investments and marketing strategies efficiently, often outmaneuvering larger competitors in clinical efficacy and branding within these segments.

2. Robust R&D Pipeline

Investments in research and development underpin USL’s long-term growth prospects. The firm’s R&D centers focus on novel formulations, biosimilars, and enhanced delivery mechanisms, such as transdermal patches for dermatological applications. Strategic collaborations with biotech firms and academic institutions facilitate innovation and fast-tracking of promising compounds.

3. Strong Regulatory and Intellectual Property Portfolio

USL’s compliance with regulatory frameworks like the FDA, EMA, and other agencies assures product safety and approval efficacy. Additionally, the company holds a significant number of patents within key jurisdictions—protecting its formulations and exclusive delivery technologies—an advantage against generic competition.

4. Strategic Alliances and Acquisition Strategy

Forming strategic alliances with clinical research organizations and engaging in targeted acquisitions have amplified USL’s market reach. These partnerships enhance manufacturing capacity, accelerate product approval timelines, and broaden product portfolios across geographical regions.

5. Focused Geographic and Customer Segmentation

By targeting specific demographic and geographic markets, including underserved regions, USL manages operational efficiency and brand recognition. Such focus minimizes competitive dilution and facilitates tailored customer engagement.

Strategic Insights and Future Directions

Innovative Expansion and Diversification

USL’s future success hinges on expanding its therapeutic pipeline. Prioritizing biologics, biosimilars, and personalized medicine can unlock new revenue streams. Strategic investments in digital health tools and remote monitoring devices align with evolving healthcare delivery trends, offering opportunities for integrated treatment solutions.

Investing in Digital Transformation

Adopting advanced data analytics, AI-driven drug discovery, and supply chain digitization can optimize R&D efficiency and manufacturing agility. USL's integration of digital platforms for real-time market data collection enhances strategic decision-making and customer engagement.

Enhanced Market Access & Pricing Strategies

Navigating complex regulatory environments and reimbursement landscapes requires USL to develop precise pricing models and health-economic value propositions. Engaging with payers and policymakers proactively can facilitate smoother market entry and favorable reimbursement terms.

Geographical Expansion

Targeting emerging markets with growing healthcare infrastructure such as Asia-Pacific and Latin America presents significant growth opportunities. Local partnerships and compliance strategies tailored to regional regulatory nuances can accelerate market penetration.

Sustainability and Corporate Responsibility

Aligning operations with environmental sustainability and corporate social responsibility (CSR) enhances brand value and stakeholder trust. USL’s initiatives on sustainable manufacturing, waste management, and community health investments are critical in today’s socially conscious climate.

Competitive Challenges and Risks

  • Regulatory hurdles: Complete compliance with complex, evolving global regulations remains resource intensive.
  • Market saturation: Niche therapeutic markets face intense competition from generic incumbents and disruptive biotech entrants.
  • Pricing pressures: Governments and insurers increasingly leverage pricing negotiations, impacting profit margins.
  • Innovation risks: R&D pipelines may encounter clinical or regulatory setbacks, delaying product launches.

Conclusion

Upsher Smith Labs' strategic focus on specialized therapeutic sectors, robust R&D investments, and targeted market engagement establish it as a resilient and innovative mid-tier pharmaceutical company. Leveraging digital transformation, expanding geographically, and fostering strategic alliances will be pivotal in consolidating its market position amidst an increasingly competitive landscape.

Key Takeaways:

  • USL’s specialization in neurology and dermatology affords a competitive edge in niche markets.
  • Continuous innovation and patent protection safeguard against generic competition.
  • Expanding into biologics and personalized medicine can diversify revenue streams.
  • Digital transformation enhances operational efficiency and market responsiveness.
  • Strategic geographic expansion into emerging regions unlocks new growth opportunities.

FAQs

1. What differentiates Upsher Smith Labs from larger pharmaceutical companies?
USL's focus on niche therapeutic areas, personalized patient solutions, and innovative formulations sets it apart from broad-spectrum giants, allowing for targeted marketing and specialized R&D.

2. How does USL protect its products from generic competition?
USL employs patent filings, proprietary delivery technologies, and regulatory exclusivities to secure a competitive moat around its key products.

3. What are the main growth opportunities for USL?
Expanding into biologics, biosimilars, and emerging markets offers significant revenue prospects. Investing in digital health integrations further enhances growth potential.

4. How does regulatory compliance impact USL’s operations?
Navigating and maintaining compliance with global regulatory standards ensures market access, prolongs product exclusivity, and mitigates legal risks.

5. What strategic risks does USL face moving forward?
Developments include regulatory delays, intense competition, price pressures, and R&D failures, all of which could impact its financial stability and market positioning.


References

[1] Industry Reports, MarketWatch, 2023.
[2] USL Corporate Website, Annual Reports, 2022.
[3] FDA Database, Product Approvals, 2023.
[4] GlobalData, Pharmaceutical Market Analysis, 2023.
[5] Company Press Releases, Strategic Partnerships, 2022-2023.

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