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

Last Updated: July 17, 2025

Osmotica Pharm Us Company Profile


✉ Email this page to a colleague

« Back to Dashboard


Summary for Osmotica Pharm Us
International Patents:4
US Patents:5
Tradenames:9
Ingredients:8
NDAs:9

Drugs and US Patents for Osmotica Pharm Us

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Osmotica Pharm Us RELEXXII methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 216117-007 Jun 23, 2022 RX Yes Yes 10,265,308 ⤷  Try for Free Y ⤷  Try for Free
Osmotica Pharm Us CARBAMAZEPINE carbamazepine TABLET, EXTENDED RELEASE;ORAL 215664-001 Oct 22, 2024 DISCN No No ⤷  Try for Free ⤷  Try for Free
Osmotica Pharm Us RELEXXII methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 216117-003 Jun 23, 2022 RX Yes No 9,855,258 ⤷  Try for Free Y ⤷  Try for Free
Osmotica Pharm Us RELEXXII methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 216117-003 Jun 23, 2022 RX Yes No 10,265,308 ⤷  Try for Free Y ⤷  Try for Free
Osmotica Pharm Us DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 203114-001 Jan 26, 2016 DISCN No No ⤷  Try for Free ⤷  Try for 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 Osmotica Pharm Us

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Osmotica Pharm Us VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-003 May 20, 2008 6,403,120 ⤷  Try for Free
Osmotica Pharm Us VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-003 May 20, 2008 6,419,958 ⤷  Try for Free
Osmotica Pharm Us VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-001 May 20, 2008 6,403,120 ⤷  Try for Free
Osmotica Pharm Us VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-004 May 20, 2008 6,403,120 ⤷  Try for Free
Osmotica Pharm Us VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-002 May 20, 2008 6,403,120 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for Osmotica Pharm Us Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0296560 2/1998 Austria ⤷  Try for Free PRODUCT NAME: DONEPEZIL UND SEINE PHARMAKOLOGISCH ANNEHMBAREN SALZE, INSBESONDERE DONEPEZIL HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-22056, 1-22057 19970728; FIRST REGISTRATION: GB PL105550006, PL105550007 19970214
0296560 SPC/GB97/023 United Kingdom ⤷  Try for Free PRODUCT NAME: DONEPEZIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE HYDROCHLORIDE; REGISTERED: UK PL 10555/0006 19970214; UK PL 10555/0007 19970214
>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: Osmotica Pharm US – Market Position, Strengths & Strategic Insights

Last updated: February 12, 2025

In the ever-evolving pharmaceutical industry, understanding the competitive landscape is crucial for companies to maintain their market position and drive growth. Osmotica Pharmaceuticals plc, a biopharmaceutical company based in Bridgewater, New Jersey, has been making significant strides in the specialty neurology and women's health sectors. This comprehensive analysis delves into Osmotica's market position, strengths, and strategic insights, providing valuable information for industry professionals and investors alike.

Company Overview

Osmotica Pharmaceuticals plc is a fully-integrated biopharmaceutical company focused on developing, manufacturing, and commercializing specialty products[6]. The company's diverse product portfolio spans across specialty neurology and women's health, complemented by complex formulations of generic drugs[6]. This unique combination forms the foundation of Osmotica's commitment to improving patients' lives through innovative pharmaceutical solutions.

Market Position

Specialty Focus

Osmotica has strategically positioned itself in the specialty pharmaceutical market, particularly in neurology and women's health. This focus allows the company to target niche markets with potentially less competition and higher barriers to entry[1].

Product Portfolio

As of December 31, 2018, Osmotica boasted a diverse portfolio of five promoted products and approximately 37 non-promoted products[2]. This mix of specialty and generic offerings provides the company with a balanced revenue stream and multiple growth opportunities.

Proprietary Technology

One of Osmotica's key differentiators is its proprietary Osmodex drug delivery system[2]. This technology enables the company to develop extended-release formulations with unique pharmacokinetic profiles, potentially offering improved efficacy or reduced side effects compared to existing therapies.

Strengths and Competitive Advantages

Innovative Research and Development

Osmotica's R&D capabilities are a significant strength. As of December 31, 2018, the company employed 104 professionals with extensive regulatory and drug development experience[2]. This robust R&D team enables Osmotica to continually innovate and expand its product pipeline.

Efficient Product Development

The company has demonstrated a history of developing commercially successful pharmaceutical products[2]. Osmotica's efficient R&D organization allows it to generate a targeted pipeline of promising drug candidates.

Strategic Manufacturing Capabilities

In 2021, Osmotica selected Marietta, Georgia, for its first North American manufacturing site, bringing 156 jobs and a $20 million investment to the area[9]. This strategic move strengthens the company's manufacturing capabilities and enhances its control over the production process.

Experienced Management Team

Osmotica benefits from an experienced and accomplished management team led by CEO Brian Markison[2]. The team's expertise spans various areas of the pharmaceutical industry, including drug development, manufacturing, commercial operations, and finance.

Strategic Insights

Focus on Specialty Markets

Osmotica's strategy involves targeting specialty therapeutic markets with underserved patient populations[2]. This approach allows the company to leverage its expertise and proprietary technology to address unmet medical needs efficiently.

Leveraging Proprietary Technology

The company plans to expand its pipeline by leveraging its proprietary Osmodex drug delivery system to develop differentiated products[2]. This strategy could lead to the creation of novel therapies with improved efficacy or safety profiles.

Strategic Acquisitions and Partnerships

Osmotica seeks to selectively acquire or in-license approved products and late-stage product candidates that complement its existing portfolio[2]. This approach allows the company to expand its offerings and enter new markets more rapidly than through internal development alone.

Emphasis on Late-Stage Product Candidates

The company is focusing on advancing its late-stage clinical programs to diversify its revenue base and sustain future growth[2]. Notable candidates include Ontinua ER for multiple sclerosis spasticity and RVL-1201 for blepharoptosis.

Recent Developments and Future Outlook

Sale of Legacy Business

In June 2021, Osmotica announced the sale of its legacy business to Alora Pharmaceuticals LLC for $110 million upfront, with the potential for an additional $60 million in milestone payments[4]. This strategic move allows Osmotica to focus on maximizing the value of its key product, Upneeq.

Upneeq Launch and Expansion

Upneeq, the first and only FDA-approved ophthalmic solution for acquired blepharoptosis in adults, has shown promising results since its launch. The company is focusing on expanding Upneeq's presence in the medical aesthetics market while continuing to support its use in ocular medicine[7].

Broadening Distribution Channels

Osmotica has implemented various programs to broaden Upneeq's distribution channels, including Direct Dispense and Virtual Inventory programs for eye care and medical aesthetics professionals[8]. These initiatives aim to increase accessibility and drive sales growth.

Competitive Landscape Analysis

Market Dynamics

The pharmaceutical industry is highly competitive, with companies constantly vying for market share and racing to develop groundbreaking drugs[5]. Osmotica's focus on specialty markets and proprietary technology helps differentiate it from larger, more diversified pharmaceutical companies.

Key Competitors

While specific competitors vary by therapeutic area, Osmotica likely faces competition from both large pharmaceutical companies and smaller specialty pharma firms. Competitors may include companies focused on neurology, women's health, and those with similar drug delivery technologies.

Competitive Intelligence Strategies

To maintain its competitive edge, Osmotica must engage in proactive pharmaceutical competitive intelligence[10]. This involves:

  1. Continuous monitoring of competitor activities
  2. Analysis of patent landscapes
  3. Tracking regulatory strategies of competitors
  4. Evaluating financial performance of key players
  5. Assessing product portfolios and pipelines
"Competitor analysis is not about copying what others are doing. It's about understanding the competitive landscape so you can chart your own unique course to success." – Dr. Jane Smith, Pharmaceutical Strategy Expert[5]

SWOT Analysis

Strengths

  • Proprietary Osmodex drug delivery system
  • Diverse product portfolio across specialty and generic markets
  • Strong R&D capabilities
  • Experienced management team

Weaknesses

  • Relatively smaller size compared to big pharma companies
  • Dependence on key products like Upneeq for future growth

Opportunities

  • Expansion into new therapeutic areas
  • Potential for strategic partnerships or acquisitions
  • Growing demand for specialty pharmaceutical products

Threats

  • Intense competition in the pharmaceutical industry
  • Regulatory challenges and changes
  • Patent expirations and generic competition

Future Strategies and Growth Potential

Expanding Upneeq's Market Presence

Osmotica's near-term focus is on continuing the rollout of Upneeq in the medical aesthetics market while supporting its use in ocular medicine[8]. The company aims to raise awareness of acquired ptosis and Upneeq through various marketing channels.

Pipeline Development

Continued investment in R&D to advance late-stage product candidates and leverage the Osmodex technology for new drug development will be crucial for long-term growth.

Strategic Partnerships

Exploring partnerships or collaborations could help Osmotica expand its reach, access new technologies, or enter new markets more efficiently.

Geographic Expansion

While currently focused on the U.S. market, Osmotica may consider expanding its presence in international markets to drive future growth.

Key Takeaways

  • Osmotica Pharmaceuticals plc is a specialty biopharmaceutical company focused on neurology and women's health.
  • The company's proprietary Osmodex drug delivery system is a key differentiator in the market.
  • Upneeq, Osmotica's FDA-approved treatment for acquired blepharoptosis, represents a significant growth opportunity.
  • The sale of its legacy business allows Osmotica to focus on core growth areas and maximize the value of Upneeq.
  • Continued investment in R&D and strategic partnerships will be crucial for Osmotica's future success in the competitive pharmaceutical landscape.

FAQs

  1. What is Osmotica Pharmaceuticals' main focus? Osmotica focuses on developing and commercializing specialty products in neurology and women's health, along with complex generic formulations.

  2. How does Osmotica differentiate itself from competitors? Osmotica differentiates itself through its proprietary Osmodex drug delivery system, which allows for the development of unique extended-release formulations.

  3. What is Upneeq, and why is it important for Osmotica? Upneeq is the first FDA-approved ophthalmic solution for acquired blepharoptosis in adults. It represents a significant growth opportunity for Osmotica in both the medical aesthetics and ocular medicine markets.

  4. How has Osmotica recently restructured its business? In 2021, Osmotica sold its legacy business to Alora Pharmaceuticals LLC, allowing the company to focus on maximizing the value of Upneeq and other core growth areas.

  5. What are some key challenges Osmotica faces in the pharmaceutical market? Challenges include intense competition, regulatory hurdles, the need for continuous innovation, and the potential threat of generic competition for key products.

Sources cited: [1] https://www.barchart.com/stocks/quotes/OSMT/profile [2] https://www.annualreports.com/HostedData/AnnualReportArchive/o/NASDAQ_OSMT_2018.pdf [4] https://www.globenewswire.com/news-release/2021/06/25/2253136/0/en/Osmotica-Pharmaceuticals-plc-Announces-Conclusion-of-Strategic-Process-with-Agreement-for-the-Sale-of-Legacy-Business-to-Alora-Pharmaceuticals-LLC.html [5] https://www.drugpatentwatch.com/blog/the-importance-of-pharmaceutical-competitor-analysis/ [6] https://osmotica.com/investors/company-profile/ [7] https://www.stocktitan.net/news/OSMT/osmotica-pharmaceuticals-plc-reports-second-quarter-2021-results-and-11bu95ctvyu6.html [8] https://www.annualreports.com/HostedData/AnnualReports/PDF/NASDAQ_OSMT_2022.pdf [9] https://selectcobb.com/osmotica-announcement-strengthens-cobb-county-and-metro-atlantas-bioscience-industry-cluster/ [10] https://researchamericainc.com/resources/pharmaceutical-competitive-intelligence.php

More… ↓

⤷  Try for 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. 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.