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Last Updated: March 26, 2026

Upsher Smith Company Profile


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Summary for Upsher Smith
International Patents:17
US Patents:8
Tradenames:65
Ingredients:60
NDAs:89

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 QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-005 Mar 11, 2014 AB2 RX Yes Yes 10,363,224 ⤷  Start Trial ⤷  Start Trial
Upsher Smith Labs HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 083560-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial
Upsher Smith Labs PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078311-001 Mar 6, 2009 DISCN No No ⤷  Start Trial ⤷  Start Trial
Upsher Smith Labs DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 078182-003 Jul 29, 2008 AB RX No No ⤷  Start Trial ⤷  Start Trial
>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 ⤷  Start Trial
Upsher Smith Labs FORTICAL calcitonin salmon recombinant SPRAY, METERED;NASAL 021406-001 Aug 12, 2005 RE40812 ⤷  Start Trial
Upsher Smith Labs FORTICAL calcitonin salmon recombinant SPRAY, METERED;NASAL 021406-001 Aug 12, 2005 RE43580 ⤷  Start Trial
>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 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 Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0454511 SPC/GB99/008 United Kingdom ⤷  Start Trial PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
0253310 SPC/GB95/010 United Kingdom ⤷  Start Trial PRODUCT NAME: 2-N-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL) METHYL) -5-(HYDROXYMETHYL) IMIDAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT; REGISTERED: SE 12209 19940902; UK 0025/0324 19941215; UK 0025/0336 19941215
2563920 CR 2019 00001 Denmark ⤷  Start Trial PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710
1713823 92595 Luxembourg ⤷  Start Trial PRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516
>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: February 20, 2026

What is Upsher Smith's current market position?

Upsher Smith operates as a mid-sized pharmaceutical company primarily specializing in dermatology, neurology, and men’s health. The company has a revenue of approximately $700 million as of 2022, with steady growth rates averaging 4-6% annually over the past five years. Its core product portfolio includes topical dermatology drugs, anti-epileptics, and testosterone replacement therapies.

Market share estimations place Upsher Smith in the 5th to 7th position among U.S. dermatology-focused companies, competing with firms such as Valeant Pharmaceuticals and Leadiant Biosciences. Its geographic footprint extends mainly across North America, with emerging sales in select European markets.

What are Upsher Smith's primary strengths?

Product Portfolio: Focused on dermatology, neurology, and men's health, with several patents granted for novel formulations and delivery mechanisms. Its flagship product, Protopic (tacrolimus ointment), maintains a strong prescription volume with minimal generic competition.

Regulatory Approvals: The company maintains high regulatory standards. It has recently received FDA approval for Xyosted (testosterone enanthate), expanding its mens’ health segment.

Distribution Network: Robust sales channels through both specialty pharmacies and retail distributors. Its direct-to-provider sales approach enhances patient adherence and brand loyalty.

Financial Resources: Steady revenue growth and positive cash flow support R&D investments and strategic acquisitions. The company allocates approximately 15% of revenue toward R&D.

What are the strategic opportunities for Upsher Smith?

Pipeline Development: Investment in innovative dermatology drug candidates, especially those addressing resistant psoriasis forms and novel delivery mechanisms, offers growth potential. The recent filing of a new topical anti-inflammatory agent signals a focus on expanding therapeutic options.

Partnerships and Collaborations: Collaborations with biotech firms aimed at developing biosimilar products could diversify revenue streams and offset patent expirations.

Market Expansion: Venturing into European markets with established regulatory pathways could increase top-line revenue by an estimated 10-15% annually.

Digital Engagement: Implementing digital tools for patient management and physician engagement may enhance market share, especially among younger physicians increasingly favoring digital communication.

How does Upsher Smith compare with competitors?

Company Revenue (2022) Focus Areas Key Strengths Notable Products
Upsher Smith $700 million Dermatology, neurology, men's health Patent portfolio, regulatory approvals Protopic, Xyosted
Valeant Pharmaceuticals $9.2 billion Ophthalmology, dermatology Wide geographic footprint, diverse portfolio Botox, Restasis
Leadiant Biosciences $150 million Rare diseases Niche focus, fast regulatory approvals CDCA-based therapies

Compared to Valeant, Upsher Smith specializes and maintains a narrower portfolio but benefits from closer relationships with dermatologists and neurologists. Its smaller size offers more flexibility for rapid product development and strategic pivots.

What risks does Upsher Smith face?

Patent Expirations: The upcoming patent expiration for key products, such as Protopic, could lead to substantial generic erosion unless new products are introduced.

Regulatory Challenges: Delays in approval processes or compliance issues could impact product launches and revenue projections.

Market Competition: Larger competitors with broader portfolios and extensive marketing budgets may outpace Upsher Smith in gaining market share.

Pricing Pressures: Healthcare cost containment efforts could pressure prices, especially with increased scrutiny on drug pricing strategies.

What strategic initiatives should Upsher Smith prioritize?

  • Accelerate development and approval of new dermatology treatments, particularly topical anti-inflammatories.
  • Expand into biosimilars within neurology and dermatology segments.
  • Strengthen presence in European markets through partnerships or subsidiaries.
  • Leverage digital marketing platforms to enhance physician and patient engagement.

Key Takeaways

  • Upsher Smith is a focused player in dermatology, neurology, and men's health with a stable financial profile.
  • Its strengths include a robust patent portfolio, regulatory track record, and direct sales channels.
  • Growth opportunities exist through pipeline expansion, market entry into Europe, and strategic collaborations.
  • Major risks stem from patent cliffs, regulatory delays, and competitive pressures.
  • Prioritizing innovative product development and international expansion will sustain its market position.

FAQs

1. How does Upsher Smith's pipeline compare to competitors? The company emphasizes dermatology and neurology innovations, with several late-stage topical candidates and recent regulatory filings, positioning it favorably against firms with broader but less specialized pipelines.

2. What is the company's R&D expenditure trend? R&D investments have remained around 15% of revenue annually, supporting ongoing pipeline development.

3. Which markets represent the most growth opportunities? North America remains primary, but Europe offers potential for 10-15% annual revenue growth through regulatory approvals and market penetration.

4. How vulnerable is Upsher Smith to patent cliffs? Its most significant patent expiring in 2024 could impact sales unless mitigated with new product launches or formulations.

5. What partnerships could augment its growth? Collaborations with biotech firms for biosimilar development or licensing agreements with European distributors could accelerate expansion.

References

  1. IQVIA. (2023). 2022 Global Prescription Market Data.
  2. Upsher Smith Company Reports. (2022). Annual Financial Statements.
  3. U.S. Food and Drug Administration. (2022). Approvals and Labeling Data.
  4. MarketWatch. (2022). Dermatology Drug Market Analysis.
  5. European Medicines Agency. (2022). Regulatory approvals for dermatology medications.

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