Assertio Bundle
What is Assertio Holdings, Inc.'s History?
Assertio Holdings, Inc. is a specialty pharmaceutical company with a history of strategic changes. It was formerly known as Depomed, Inc. and underwent a significant transformation in 2020.
The company's journey began in 1995 as Depomed, Inc., focusing on developing and commercializing medical treatments. Today, it operates as a commercial pharmaceutical company, emphasizing a digital-first strategy.
What is the brief history of Assertio Holdings, Inc.?
Assertio Holdings, Inc., previously Depomed, Inc., was founded in 1995. The company rebranded and transformed into Assertio Holdings, Inc. in 2020. Initially, Depomed focused on innovative drug delivery technologies. Assertio now concentrates on commercializing differentiated products in areas like neurology and pain management. Their current operational model is lean and digitally driven, aiming to enhance product value. This strategic shift reflects their adaptability in the evolving pharmaceutical market, with a portfolio that includes treatments like Assertio PESTEL Analysis.
What is the Assertio Founding Story?
The genesis of what is now known as Assertio Holdings, Inc. began on August 7, 1995, with the establishment of Depomed, Inc. in Newark, California. The company's foundational strategy centered on pharmaceutical development, with an early focus on enhancing the bioavailability of existing drugs through innovative delivery systems.
The Founding Story of Assertio
Depomed, Inc., the precursor to Assertio, was founded in 1995 with a mission to improve drug delivery. Its early efforts were driven by proprietary technology designed to control the release of medications.
- Founded as Depomed, Inc. on August 7, 1995.
- Early strategy focused on pharmaceutical development and partnerships.
- Developed proprietary Acuform technology for controlled drug release.
- Aimed to reduce side effects and necessary dosages of oral medications.
Depomed's proprietary Acuform technology was a cornerstone of its early innovation. This gastroretentive polymer formulation was designed to allow for the controlled release of therapeutic compounds over an extended period, significantly improving upon traditional drug release profiles and aiming to reduce side effects and lower required doses for oral medications. This technological advancement was key to the Assertio company history and its subsequent growth.
The company's early product development included Gralise, a once-daily gabapentin extended-release formulation approved by the FDA in January 2011 for postherpetic neuralgia, and Glumetza, used for type II diabetes treatment. A notable aspect of its early corporate structure was a joint venture with Élan, DDL, established in January 2000. Depomed later acquired full ownership of this venture in September 2003, securing exclusive rights to develop and commercialize Gabapentin ER. Initial funding for the Assertio company was primarily sourced through such strategic collaborations and internal development efforts, reflecting a focused approach to building its pharmaceutical portfolio.
The company's initial name, Depomed, directly reflected its core focus on drug delivery methods, a theme that has continued to shape the Assertio Therapeutics history. Understanding this early period is crucial for grasping the Assertio company background information and its trajectory in the pharmaceutical industry. The evolution of its product pipeline and strategic alliances laid the groundwork for its future development and market presence, contributing to the broader Assertio company timeline.
The strategic evolution of the company, including its early focus on drug delivery technologies, has been a significant factor in its growth. This approach to product development and market entry is a key element in understanding the Marketing Strategy of Assertio. The company's commitment to enhancing existing therapies through innovative delivery systems marked its initial steps in the competitive pharmaceutical landscape.
Assertio SWOT Analysis
- Complete SWOT Breakdown
- Fully Customizable
- Editable in Excel & Word
- Professional Formatting
- Investor-Ready Format
What Drove the Early Growth of Assertio?
The early history of the Assertio company, then known as Depomed, Inc., was characterized by strategic product development and significant acquisitions aimed at expanding its market presence. This period laid the groundwork for its evolution into a focused pharmaceutical entity.
Product Portfolio Expansion
Following the FDA approval of Gralise in January 2011, Depomed strategically acquired the rights to Zipsor, an NSAID for pain management, in June 2012. This marked a key step in broadening its therapeutic offerings.
Major Acquisition and Sales Force Growth
A pivotal moment in the Assertio Therapeutics history was the January 2015 acquisition of the Nucynta franchise for $1.05 billion. This was swiftly followed by a significant expansion of its sales force in June 2015 to support the relaunched products.
Operational and Strategic Shifts
The company's operational footprint saw changes, including a headquarters relocation from Newark, California, to Lake Forest, Illinois, in 2018. A leadership transition occurred in March 2017 with Arthur Higgins succeeding Jim Schoeneck as CEO.
Strategic Pivot and Rebranding
In a significant strategic pivot, Depomed divested its Nucynta opioid franchise in December 2017, leading to a 40% workforce reduction in January 2018. This shift culminated in the rebranding to Assertio Therapeutics, Inc. on August 15, 2018, signaling a new direction. The company's evolution continued with its merger with Zyla Life Sciences in May 2020, resulting in the current entity, Assertio Holdings, Inc. Understanding these shifts is crucial when examining the Competitors Landscape of Assertio.
Assertio PESTLE Analysis
- Covers All 6 PESTLE Categories
- No Research Needed – Save Hours of Work
- Built by Experts, Trusted by Consultants
- Instant Download, Ready to Use
- 100% Editable, Fully Customizable
What are the key Milestones in Assertio history?
The Assertio company history is marked by strategic product development and adaptation to market dynamics. From its early days as Depomed, the company focused on leveraging its proprietary technologies to bring new therapeutic options to market, navigating both successes and setbacks in the competitive pharmaceutical landscape. Understanding the Assertio Therapeutics history reveals a journey of innovation and resilience.
| Year | Milestone |
|---|---|
| 2011 | Received FDA approval for Gralise, utilizing the Acuform technology. |
| Ongoing | Expanded portfolio with FDA-approved products including Cambia, Zipsor, Indocin, Sympazan, Otrexup, and Rolvedon. |
| 2017 | Experienced significant drug shortages of Nucynta due to manufacturing disruptions. |
| 2019 | Operating income reported at $3.33 million, reflecting a challenging diversification period. |
| Late 2023/Early 2024 | Faced generic competition for its Indocin product, impacting volume and pricing. |
| Q1 2025 | Incurred a reported $2.8 million legal settlement charge related to opioid litigation. |
| 2025 | Initiated a transformation strategy focusing on reducing legal exposure and prioritizing growth assets. |
A key innovation was the Acuform technology, a gastroretentive polymer formulation designed for extended and controlled release of small molecule therapeutics. This technology aimed to enhance drug efficacy and reduce the frequency of dosing for patients.
Acuform Technology
This proprietary gastroretentive polymer formulation enabled extended and controlled release of small molecule therapeutics. It was instrumental in improving drug efficacy and reducing dosing frequency for patients.
Gralise Approval
The FDA approval of Gralise in 2011 marked a significant product milestone, showcasing the successful application of the Acuform technology. This product addressed the need for improved management of neuropathic pain.
Rolvedon Launch
The introduction of Rolvedon, a long-acting granulocyte colony-stimulating factor, represented a more recent addition to the company's portfolio. This product targets specific therapeutic areas and demonstrates ongoing product development efforts.
Portfolio Expansion
The company strategically expanded its product portfolio over the years, securing FDA approvals for a range of medications. This diversification aimed to broaden its market presence and revenue streams.
Otrexup Commercialization
The decision to cease commercialization of Otrexup in 2025 is part of a strategic repositioning. This move reflects a focus on prioritizing investment in core growth assets and divesting non-essential products.
Sympazan Development
Sympazan is highlighted as a key growth asset, indicating continued investment and focus on its market potential. This product is part of the company's strategy to drive future growth and financial stability.
Assertio has faced significant challenges, including major drug shortages and a difficult market reception that impacted its stock value. The company has also contended with the financial and operational implications of legal liabilities, particularly those related to opioid litigation.
Drug Shortages
In 2017, the company experienced substantial drug shortages of Nucynta, primarily due to the impact of Hurricane Maria on its Puerto Rico manufacturing facility. This event disrupted supply chains and affected product availability.
Market Reception and Financial Performance
Between 2016 and 2019, the company faced a challenging market, with its stock value declining significantly by March 2019. Operating income in 2019 was reported at $3.33 million, indicating difficulties with its diversification strategy.
Generic Competition
The introduction of generic competition for its Indocin product in late 2023 and early 2024 has presented ongoing challenges. This has led to pressures on both the volume of sales and the pricing of the product.
Legal Liabilities
The company has incurred significant legal liabilities, notably those stemming from opioid litigation. Assertio has been actively engaged in managing and settling these cases, including a $2.8 million legal settlement charge recorded in Q1 2025.
Strategic Repositioning
In response to these challenges, Assertio initiated a comprehensive transformation strategy in 2025. This strategy is designed to reduce legal exposure, streamline the corporate structure, and reallocate resources towards key growth assets, a move that also impacts its Target Market of Assertio.
Divestment of Non-Core Assets
As part of its strategic repositioning, the company decided to cease the commercialization of Otrexup. This action is consistent with its focus on prioritizing investment in growth assets like Rolvedon and Sympazan.
Assertio Business Model Canvas
- Complete 9-Block Business Model Canvas
- Effortlessly Communicate Your Business Strategy
- Investor-Ready BMC Format
- 100% Editable and Customizable
- Clear and Structured Layout
What is the Timeline of Key Events for Assertio?
The Assertio company history is marked by significant strategic shifts and growth, evolving from its origins as Depomed, Inc. to its current form as Assertio Holdings, Inc. This journey includes key product developments, acquisitions, and divestitures, shaping its presence in the pharmaceutical sector.
| Year | Key Event |
|---|---|
| 1995 | Depomed, Inc. was founded in Newark, California, marking the initial steps of the Assertio pharmaceutical history. |
| 2000 | A joint venture, DDL, was established with Élan for pharmaceutical development, a crucial early step in the Assertio Therapeutics history. |
| 2003 | Depomed gained full ownership of DDL and secured exclusive rights to develop Gabapentin ER. |
| 2011 | Gralise received FDA approval for the treatment of postherpetic neuralgia. |
| 2012 | The company acquired the rights to Zipsor from Xanodyne Pharmaceuticals. |
| 2015 | Assertio acquired the Nucynta franchise from Janssen Pharmaceutica for $1.05 billion, a significant expansion in its Assertio company timeline. |
| 2017 | The Nucynta franchise was divested to Collegium Pharmaceutical, signaling an exit from the opioid market. |
| 2018 | Depomed, Inc. officially changed its name to Assertio Therapeutics, Inc., and relocated its headquarters to Lake Forest, Illinois. |
| 2020 | Assertio Therapeutics, Inc. merged with Zyla Life Sciences, becoming Assertio Holdings, Inc., a key event in Assertio company growth and development. |
| 2023 | Assertio completed the acquisition of Spectrum Pharmaceuticals, and generic competition for Indocin began. |
| 2024 | Full-year net product sales were reported at $120.8 million, with cash and investments totaling $100.1 million. |
| 2025 | Q1 2025 net product sales were $26.0 million, with cash and investments at $87.3 million; Q2 2025 net product sales reached $28.8 million, with cash and investments at $98.2 million. |
Driving Growth in 2025
Assertio anticipates 2025 to be a pivotal year, focusing on revenue expansion from key products like Rolvedon and Sympazan. The company is also actively seeking strategic acquisitions to bolster its commercial capabilities.
Financial Guidance and Strategic Focus
For the full year 2025, Assertio has revised its net product sales guidance to a range of $108.0 million to $118.0 million. Adjusted EBITDA guidance is set between $11.0 million and $19.0 million.
Operational Streamlining and Future Vision
The company's strategy includes streamlining operations and reducing legal liabilities. Assertio aims to transition into a 'growth phase' starting in 2026, positioning itself as a leading commercial specialty pharmaceutical company.
Commitment to Patient Lives
This forward-looking approach aligns with the company's foundational objective of improving patient outcomes through innovative therapeutic solutions. Understanding the Mission, Vision & Core Values of Assertio provides further insight into this commitment.
Assertio Porter's Five Forces Analysis
- Covers All 5 Competitive Forces in Detail
- Structured for Consultants, Students, and Founders
- 100% Editable in Microsoft Word & Excel
- Instant Digital Download – Use Immediately
- Compatible with Mac & PC – Fully Unlocked
- What is Competitive Landscape of Assertio Company?
- What is Growth Strategy and Future Prospects of Assertio Company?
- How Does Assertio Company Work?
- What is Sales and Marketing Strategy of Assertio Company?
- What are Mission Vision & Core Values of Assertio Company?
- Who Owns Assertio Company?
- What is Customer Demographics and Target Market of Assertio Company?
Disclaimer
All information, articles, and product details provided on this website are for general informational and educational purposes only. We do not claim any ownership over, nor do we intend to infringe upon, any trademarks, copyrights, logos, brand names, or other intellectual property mentioned or depicted on this site. Such intellectual property remains the property of its respective owners, and any references here are made solely for identification or informational purposes, without implying any affiliation, endorsement, or partnership.
We make no representations or warranties, express or implied, regarding the accuracy, completeness, or suitability of any content or products presented. Nothing on this website should be construed as legal, tax, investment, financial, medical, or other professional advice. In addition, no part of this site—including articles or product references—constitutes a solicitation, recommendation, endorsement, advertisement, or offer to buy or sell any securities, franchises, or other financial instruments, particularly in jurisdictions where such activity would be unlawful.
All content is of a general nature and may not address the specific circumstances of any individual or entity. It is not a substitute for professional advice or services. Any actions you take based on the information provided here are strictly at your own risk. You accept full responsibility for any decisions or outcomes arising from your use of this website and agree to release us from any liability in connection with your use of, or reliance upon, the content or products found herein.