You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 8, 2025

PADAGIS US Company Profile


✉ Email this page to a colleague

« Back to Dashboard


Summary for PADAGIS US
International Patents:22
US Patents:1
Tradenames:67
Ingredients:62
NDAs:91
PTAB Cases with PADAGIS US as petitioner: See PTAB cases with PADAGIS US as petitioner

Drugs and US Patents for PADAGIS US

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Padagis Us NYSTOP nystatin POWDER;TOPICAL 064118-001 Aug 16, 1996 AT RX No No ⤷  Get Started Free ⤷  Get Started Free
Padagis Us FLAVOXATE HYDROCHLORIDE flavoxate hydrochloride TABLET;ORAL 076831-001 Dec 16, 2004 AB RX No Yes ⤷  Get Started Free ⤷  Get Started Free
Padagis Us TRETINOIN tretinoin GEL;TOPICAL 075589-001 Jun 11, 2002 AB RX No No ⤷  Get Started Free ⤷  Get Started Free
Padagis Us CLINDAMYCIN PALMITATE HYDROCHLORIDE clindamycin palmitate hydrochloride FOR SOLUTION;ORAL 090902-001 Jul 7, 2010 AA RX No No ⤷  Get Started Free ⤷  Get Started Free
Padagis Us POTASSIUM CHLORIDE potassium chloride TABLET, EXTENDED RELEASE;ORAL 205993-001 Nov 5, 2015 AB2 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 PADAGIS US

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Padagis Us CENTANY mupirocin OINTMENT;TOPICAL 050788-001 Dec 4, 2002 6,013,657 ⤷  Get Started Free
Padagis Us BUTOCONAZOLE NITRATE butoconazole nitrate CREAM;VAGINAL 019881-001 Feb 7, 1997 4,551,148 ⤷  Get Started Free
Padagis Us CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793-001 Nov 30, 2004 5,993,856 ⤷  Get Started Free
Padagis Us EVAMIST estradiol SPRAY;TRANSDERMAL 022014-001 Jul 27, 2007 6,299,900 ⤷  Get Started Free
Padagis Us EVAMIST estradiol SPRAY;TRANSDERMAL 022014-001 Jul 27, 2007 6,978,945 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for PADAGIS US drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Enteric Coated Capsules 3 mg ➤ Subscribe 2008-02-01
➤ Subscribe Vaginal Cream 2% ➤ Subscribe 2015-02-05

Supplementary Protection Certificates for PADAGIS US Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0480717 98C0025 Belgium ⤷  Get Started Free PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
2957286 2018/046 Ireland ⤷  Get Started Free PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
0617614 SPC/GB01/014 United Kingdom ⤷  Get Started Free PRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018
1441735 SPC/GB08/020 United Kingdom ⤷  Get Started Free PRODUCT NAME: RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; REGISTERED: UK EU/1/07/436/001 20080102
2957286 LUC00094 Luxembourg ⤷  Get Started Free PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
>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: Padagis US – Market Position, Strengths & Strategic Insights

Last updated: July 28, 2025

Introduction

In the rapidly evolving U.S. pharmaceutical sector, Padagis emerges as a notable player, leveraging strategic advantages to carve a distinct niche within the generic and over-the-counter (OTC) drug markets. As the industry witnesses intense competition driven by patent expirations, regulatory changes, and innovation in formulations, understanding Padagis's market position, strengths, and strategic trajectory is essential for stakeholders aiming to capitalize on emerging opportunities and mitigate risks.

Company Overview and Market Position

Padagis operates in the highly competitive landscape of the United States pharmaceutical industry, primarily focusing on OTC and generic products. The company's footprint extends across various therapeutic categories, including respiratory, analgesics, and gastrointestinal segments, aligning with prevailing consumer demands and healthcare trends.

Market analysts position Padagis as an agile player with a robust portfolio, benefiting from its strategic manufacturing footprint and extensive distribution channels. According to IQVIA data, the OTC segment in the U.S. registered sales exceeding $45 billion in 2022, with key players like Johnson & Johnson, Pfizer, and GSK holding dominant positions [1]. Padagis, while smaller compared to industry giants, has been steadily increasing its market share through targeted product launches, acquisitions, and innovation.

Padagis’s strategic focus toward high-volume, margin-rich OTC formulations, combined with its commitment to cost-effective manufacturing, enhances its competitiveness. The company's recent acquisitions of certain OTC brands and active ingredient portfolios suggest a deliberate strategy to expand its market footprint, especially within categories experiencing growth such as respiratory and analgesics.

Strengths of Padagis

1. Robust Product Portfolio and Innovation Capacity

Padagis maintains a diversified portfolio of OTC products, including well-established brands and pipeline products. Its emphasis on innovation, such as reformulating existing products with improved delivery mechanisms or enhanced efficacy, positions it advantageously against competitors reliant solely on branded products. The company's R&D focuses on inhalation therapies, pediatric formulations, and combination products, capitalizing on unmet needs within these niches.

2. Strategic Manufacturing and Supply Chain Infrastructure

The company benefits from vertically integrated manufacturing capabilities and strategic geographic positioning of production facilities. This infrastructure facilitates rapid response to market demand, cost efficiencies, and quality assurance. Its ability to swiftly scale production in response to market dynamics lends resilience amid supply chain disruptions, a critical advantage highlighted during COVID-19 disruptions.

3. Strong Distribution Network and Market Penetration

Padagis's established distribution channels enable wide availability of its products across pharmacies, health stores, and e-commerce platforms. Its partnerships with major distributors facilitate access to key retail outlets, contributing to increased shelf presence and consumer accessibility.

4. Focused Market Segmentation and Consumer-Centric Approach

Alignment with consumer preferences, such as natural ingredients, gluten-free formulations, or reduced-sugar variants, enhances brand loyalty. Padagis's commitment to health literacy and consumer education further solidifies its market presence, especially within OTC categories.

5. Strategic Partnerships and Acquisitions

Selective acquisitions of OTC brands and active ingredients provide growth avenues, diversify its product pipeline, and reinforce its market positioning. These strategic moves help Padagis expand into new therapeutic areas and consumer segments rapidly.

Strategic Insights and Future Outlook

1. Emphasis on Differentiation and Innovation

In an environment saturated with generic competition, differentiation through innovation remains vital. Padagis’s focus on reformulating existing OTC medications with improved delivery systems or combining therapeutic agents aligns with industry trends emphasizing patient-centered formulations. For example, inhalation-based therapies and pediatric-friendly formulations can command premium pricing and foster brand loyalty.

2. Expansion into Specialty and Emerging Markets

The company is well-positioned to expand into emerging segments such as respiratory therapies, pediatric care, and natural OTC products. Increasing consumer awareness around holistic health and preventive care supports this growth trajectory. Leveraging partnerships with healthcare providers and direct-to-consumer strategies could amplify market penetration.

3. Digital Transformation and E-commerce Optimization

The digital health landscape offers substantial opportunities for Padagis. Strengthening e-commerce channels and deploying targeted digital marketing can enhance consumer engagement and accelerate product adoption. The pandemic-driven shift towards online health purchasing underscores the importance of digital infrastructure.

4. Strategic M&A for Portfolio Expansion

Continued acquisitions, particularly in high-growth therapeutic niches, will likely be central to Padagis’s growth strategy. These acquisitions could facilitate quick entry into promising segments and regional markets, hedging against commoditization risks in mature categories.

5. Navigating Regulatory and Competitive Challenges

Regulatory landscape complexities pose risks; however, proactive compliance, strategic planning, and engagement with policymakers can mitigate these. Competing effectively requires vigilant patent management, rapid product development cycles, and robust supply chain resilience.

Competitive Dynamics and Industry Challenges

Padagis operates amidst fierce competition from both traditional pharmaceutical giants and innovative biotech firms. Patent expirations threaten brand dominance, elevating the importance of a flexible, innovation-led approach. Meanwhile, regulatory scrutiny around OTC labeling, manufacturing standards, and advertising presents ongoing compliance challenges.

Price pressures, especially within generics and OTC markets, necessitate cost-efficient manufacturing and strategic portfolio management. Additionally, the acceleration of digital health initiatives demands technological adaptation, including data analytics, telehealth, and direct-to-consumer engagement platforms.

Conclusion

Padagis's strategic positioning within the U.S. pharmaceutical landscape leverages its diversified product portfolio, manufacturing excellence, and targeted growth initiatives. As the industry navigates shifting consumer preferences, regulatory frameworks, and technological transformations, Padagis’s agility and focus on innovation are key differentiators. Its future success hinges on expanding through strategic acquisitions, embracing digital transformation, and continuously aligning its offerings with evolving healthcare needs.

Key Takeaways

  • Padagis's diversified OTC and generic portfolio, combined with strategic acquisitions, fortifies its market presence.
  • Innovative formulations and consumer-centric products are central to its differentiation strategy.
  • The company's manufacturing prowess and broad distribution channels provide resilience against supply chain and competitive pressures.
  • Digital transformation and e-commerce offer substantial growth opportunities.
  • Proactive regulatory navigation and strategic M&A are critical for sustained competitiveness.

FAQs

1. How does Padagis differentiate itself from other OTC pharmaceutical companies?
Padagis emphasizes product innovation with patient-centered formulations, leveraging its manufacturing capabilities and strategic acquisitions to expand high-margin segments, thereby fostering brand loyalty and market differentiation.

2. What are the key growth areas for Padagis in the U.S. market?
Key growth areas include respiratory therapies, pediatric OTC products, and natural/holistic health formulations, aligned with consumer health trends and unmet market needs.

3. How does Padagis manage supply chain risks amid industry disruptions?
Through strategically located manufacturing facilities, diversified supplier relationships, and flexible production processes, Padagis maintains supply chain resilience and rapid response capabilities.

4. What strategic initiatives should Padagis prioritize to sustain competitive advantage?
Priorities include expanding its product pipeline via M&A, embracing digital health channels, investing in innovative delivery systems, and navigating regulatory landscapes proactively.

5. What challenges does Padagis face in maintaining its market position?
Challenges include intense price competition, patent expiration pressures, regulatory compliance, and keeping pace with technological advancements in healthcare and distribution.


References

[1] IQVIA. U.S. OTC Market Data 2022.

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.