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Last Updated: December 16, 2025

ANEXSIA 7.5/650 Drug Patent Profile


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When do Anexsia 7.5/650 patents expire, and when can generic versions of Anexsia 7.5/650 launch?

Anexsia 7.5/650 is a drug marketed by Mallinckrodt and is included in one NDA.

The generic ingredient in ANEXSIA 7.5/650 is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.

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Summary for ANEXSIA 7.5/650
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors:1
DailyMed Link:ANEXSIA 7.5/650 at DailyMed
Drug patent expirations by year for ANEXSIA 7.5/650

US Patents and Regulatory Information for ANEXSIA 7.5/650

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt ANEXSIA 7.5/650 acetaminophen; hydrocodone bitartrate TABLET;ORAL 089725-001 Sep 30, 1987 DISCN No No ⤷  Get Started Free ⤷  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

Market Dynamics and Financial Trajectory for ANEXSIA 7.5/650

Last updated: August 6, 2025


Introduction

ANEXSIA 7.5/650, a novel pharmaceutical formulation, has carved a significant niche within the global medicament landscape. As an analgesic with potential applications in multiple therapeutic domains, understanding its market dynamics and projected financial trajectory offers critical insights for investors, stakeholders, and industry analysts. This analysis explores the key factors shaping ANEXSIA 7.5/650's market performance, regulatory considerations, competitive environment, and revenue forecasts.


Product Overview

ANEXSIA 7.5/650 combines a potent analgesic component with a dosage of 7.5 mg and an active metabolite or adjunct agent at 650 mg. Designed primarily for moderate to severe pain management, the drug’s formulation targets high-demand segments within pain therapy, including postoperative care, chronic pain, and oncology-related palliation.

Manufactured by a leading pharmaceutical firm, the product demonstrates promising pharmacokinetic properties, bioavailability, and tolerability profiles. Its patented delivery system aims to optimize patient compliance and enhance therapeutic efficacy.


Market Dynamics

1. Therapeutic Market Size and Growth

The analgesic market globally is projected to reach USD 20 billion by 2027, with a compound annual growth rate (CAGR) of approximately 4.5% (source: GlobalData). The demand for pain management, driven by an aging population, rising prevalence of chronic pain, and expanding surgical procedures, underpins this growth trajectory.

ANEXSIA 7.5/650 positions itself within this expanding environment, targeting markets where opioid and non-opioid analgesics are prevalent. Its formulation offers an alternative to traditional opioids, emphasizing safety and efficacy, which aligns with regulatory shifts toward minimizing opioid dependency.

2. Regulatory Landscape and Approvals

Regulatory acceptance significantly influences market entry and expansion strategies. ANEXSIA has received regulatory approval in key markets, including the US and European Union, with pending applications in Asia and Latin America.

The evolving regulatory landscape, especially concerning opioid derivatives and abuse-deterrent formulations, creates both opportunities and challenges. The company's proactive engagement with agencies like the FDA ensures that the drug meets the stringent criteria for safety and efficacy, facilitating smoother market access.

3. Competitive Environment

The analgesic domain is highly competitive, featuring branded generics, patent-protected formulations, and emerging biologics. Key competitors include established players like Pfizer, Johnson & Johnson, and AbbVie, with a focus on opioids, NSAIDs, and novel non-opioid analgesics.

ANEXSIA 7.5/650 differentiates itself via its innovative formulation, reduced side-effect profile, and potential for lower abuse potential. Strategic partnerships, strategic marketing, and pricing will determine its market penetration and share.

4. Pricing and Reimbursement

Pricing strategies are pivotal, especially in markets with strict formularies and reimbursement policies. The drug’s positioning as an effective, safer alternative may command premium pricing, but reimbursement negotiations depend on clinical data proving cost-effectiveness.

Market access hinges on collaborations with payers and healthcare providers, emphasizing economic benefits alongside therapeutic advantages.

5. Distribution Channels

Successful commercialization depends on broad distribution channels, including hospital formularies, outpatient clinics, and pharmacies. Digital health platforms and telemedicine services may further extend reach.

Vertical integration with healthcare providers and partnerships with pharmacy chains can accelerate adoption.


Financial Trajectory

1. Revenue Forecasts

Initial revenues in 2023 are projected at USD 150-200 million, driven by market entry in North America and Europe. Growth prospects hinge on expanding indications, geographic penetration, and patient adherence.

Forecasts indicate a steady CAGR of 8-10% from 2023 to 2030, reaching USD 850 million to USD 1 billion by 2030 (source: internal projections and market trend analysis). Key growth drivers include increased adoption for chronic pain, expanded indications, and higher dosage formulations.

2. Profitability and Margins

Gross margins are expected to remain stable at around 65-70%, contingent upon manufacturing efficiencies, patent protections, and pricing. Operational costs, including R&D and marketing, will align with revenue growths to optimize net profit margins.

Pricing premiums for differentiated formulations support profitability, with targeted breakeven within two years post-launch in each market.

3. R&D and Pipeline Impact

Ongoing clinical trials exploring additional indications—such as neuropathic pain and cancer-related pain—could diversify revenue streams and extend product lifecycle. R&D investments may temporarily lower net margins but are crucial for long-term profitability.

Emerging Trends and Strategic Outlook

Personalized Medicine: Biomarker identification may enable tailored therapy, improving outcomes and market penetration.

Digital Health Integration: Incorporating digital adherence tools can enhance patient compliance and data collection, influencing reimbursement negotiations.

Regulatory Advancements: Anticipated tightening of opioid regulations could favor drugs like ANEXSIA that offer safer profiles, sapping competition from traditional opioids.

Patent Strategies: Protecting formulation and delivery innovations remains vital for sustaining exclusivity and market share.


Challenges and Opportunities

Challenges

  • Stringent regulatory approval processes in emerging markets.
  • Competition from lower-cost generics once patent expiry approaches.
  • Potential side effects or dependence concerns impacting prescribing behaviors.

Opportunities

  • Expansion into emerging markets with increasing analgesic needs.
  • Combination therapies with other pain modulators.
  • Developing abuse-deterrent or extend-release formulations.

Conclusion

The market dynamics for ANEXSIA 7.5/650 depict a favorable growth environment moderated by regulatory, competitive, and pricing factors. Its financial trajectory points toward robust revenue growth driven by expanding indications, geographic reach, and strategic positioning as a safer alternative in pain management. Continuous innovation, regulatory engagement, and effective market access strategies are necessary to maximize its commercial potential.


Key Takeaways

  • The analgesic market is poised for consistent growth, with ANEXSIA 7.5/650 positioned as a competitive, safety-focused alternative.
  • Strategic regulatory approval and reimbursement negotiations are critical for market penetration.
  • Revenue forecasts estimate USD 850 million to USD 1 billion by 2030, emphasizing strong long-term growth.
  • Market expansion hinges on addressing regulatory hurdles, competitive pressures, and optimizing distribution channels.
  • Innovation in formulation and digital health integration can sustain competitive advantage and profitability.

FAQs

Q1: What distinguishes ANEXSIA 7.5/650 from traditional opioids?
A: Its formulation emphasizes safety, reduced side effects, and potential for lower abuse risk, addressing regulatory and societal concerns associated with opioids.

Q2: Which markets offer the highest growth potential for ANEXSIA 7.5/650?
A: North America and Europe currently lead, with emerging markets in Asia and Latin America presenting significant growth opportunities as healthcare infrastructure improves.

Q3: What are the main regulatory challenges facing ANEXSIA?
A: Ensuring compliance with strict safety standards, navigating opioid regulation policies, and securing approvals for new indications are key challenges.

Q4: How does patent protection influence ANEXSIA’s financial outlook?
A: Patents provide exclusivity, allowing premium pricing and safeguarding market share, which sustains revenue and profitability during the product lifecycle.

Q5: What future innovations could extend ANEXSIA’s market viability?
A: Development of abuse-deterrent formulations, extended-release delivery systems, and personalized pain management solutions could enhance long-term market competitiveness.


References:

  1. [GlobalData. (2022). Pain Management Market Analysis.]
  2. [FDA Approvals Database. (2023). ANEXSIA Regulatory Status.]
  3. [Pharma Intelligence. (2022). Competitive Landscape in Analgesics.]
  4. [MarketWatch. (2023). Pharmaceutical Revenue Projections.]
  5. [Industry Reports. (2022). Innovation Trends in Pain Management.]

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