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Last Updated: December 22, 2024

SYMADINE Drug Patent Profile


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When do Symadine patents expire, and when can generic versions of Symadine launch?

Symadine is a drug marketed by Solvay and is included in one NDA.

The generic ingredient in SYMADINE is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Symadine

A generic version of SYMADINE was approved as amantadine hydrochloride by UPSHER SMITH LABS on August 5th, 1986.

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Summary for SYMADINE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 2
DailyMed Link:SYMADINE at DailyMed
Drug patent expirations by year for SYMADINE
Recent Clinical Trials for SYMADINE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Columbia UniversityPhase 4
Edward Hines Jr. VA HospitalN/A

See all SYMADINE clinical trials

US Patents and Regulatory Information for SYMADINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Solvay SYMADINE amantadine hydrochloride CAPSULE;ORAL 071000-001 Sep 4, 1986 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

SYMADINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Active Pharmaceutical Ingredients (APIs): A Focus on the Larger Context

Introduction to Active Pharmaceutical Ingredients (APIs)

Active Pharmaceutical Ingredients (APIs) are the core components of any pharmaceutical drug, responsible for its therapeutic effect. The market for APIs is complex and influenced by various factors, including global health trends, technological advancements, and regulatory environments.

Global Market Size and Growth

The global active pharmaceutical ingredients market was estimated at USD 255.01 billion in 2024 and is projected to grow at a CAGR of 5.85% from 2025 to 2030, reaching USD 359.45 billion by 2030[1].

Key Drivers of Market Growth

Growing Demand for Pharmaceutical Drugs

The increasing prevalence of chronic diseases such as cancer, diabetes, and cardiovascular conditions, particularly in emerging markets, is a significant driver of the API market. This demand is fueled by the growing global population and the need for effective treatments[1].

Advancements in Biologics and Biosimilars

Innovations in biologics and biosimilars are boosting the demand for specialized APIs. The development of novel products, many of which are in the pipeline, is expected to further enhance market growth[1].

Shift Toward Generic Medicines

The shift toward generic medicines and the rise of contract manufacturing organizations (CMOs) are accelerating API production and distribution. This trend is driven by the need to reduce production costs and enhance profitability[1].

Type of Synthesis and Market Segmentation

Synthetic APIs

Synthetic APIs dominated the market with a share of 71.09% in 2024, driven by the higher availability of raw materials and easier synthesis protocols. The strong demand for generic drugs significantly contributes to the revenue of companies involved in synthetic API manufacturing[1].

Innovative APIs

Innovative APIs, which include novel and complex molecules, led the market with a revenue share of 63.20% in 2024. This growth is attributed to increased funding and favorable regulations for research and development facilities[1].

Regional Outlook

North America

North America dominated the API market with the largest revenue share of 38.04% in 2024. The region is characterized by a high prevalence of chronic diseases and significant research in drug development. Key players such as AbbVie Inc., Curia, Pfizer Inc., Viatris Inc., and Fresenius Kabi AG are positively influencing growth in this region[1].

Other Regions

Other regions, including Europe, Asia Pacific, Latin America, and the Middle East and Africa, are also experiencing growth driven by increasing healthcare needs and advancements in pharmaceutical research.

Contract Development and Manufacturing Organizations (CDMOs)

CDMOs are playing a crucial role in the API market by offering outsourced services that help pharmaceutical companies reduce production costs and enhance profitability. The growing trend of outsourcing is creating substantial opportunities for CDMOs, especially in the synthetic API segment[1].

Technological Advancements

High-Throughput Screening and Computational Drug Design

Advancements in high-throughput screening (HTS) and computational drug design are propelling market innovation. These technologies, along with AI, machine learning, and big data analytics, are accelerating drug discovery and development processes[3].

Integration of AI and Machine Learning

The integration of AI, machine learning, and big data analytics in drug discovery is transforming the market. These technologies enable more efficient and targeted drug development, enhancing the efficacy and safety profiles of APIs[3].

Market Trends and Challenges

Rising Focus on Targeted Therapies and Personalized Medicine

There is a rising focus on targeted therapies and personalized medicine, which is driving the demand for small molecule drugs. This trend is expected to continue, with the small molecule drug discovery market projected to reach USD 58.4 billion by 2030[3].

Expiry of Key Biologic Patents

The expiry of key biologic patents is driving the development of small molecule drugs. This surge in pipeline molecules is expected to further boost the API market[3].

Financial Trajectory

The financial trajectory of the API market is robust, with significant growth projected over the next few years. Here are some key financial highlights:

  • Market Size: The global API market was valued at USD 255.01 billion in 2024 and is expected to reach USD 359.45 billion by 2030[1].
  • CAGR: The market is projected to grow at a CAGR of 5.85% from 2025 to 2030[1].
  • Revenue Segments: Synthetic APIs and innovative APIs are the leading revenue segments, driven by the demand for generic drugs and novel therapeutic agents[1].

Examples and Case Studies

Cambrex Expansion

In October 2023, Cambrex announced the completion of its USD 38 million small molecule API manufacturing facility, effectively doubling the size of its operations. This expansion highlights the growing demand for specialized API manufacturing capabilities[1].

Viatris FDA Approval

In February 2022, Viatris received FDA approval for Generic Restasis, a cyclosporine ophthalmic emulsion for treating dry eye disease. This approval underscores the importance of generic medicines in the API market[1].

Regulatory Environment

The regulatory environment plays a crucial role in the API market. Favorable regulations for research and development, along with growing support from regulatory agencies for the approval of new drugs, are anticipated to further enhance market growth[1].

Key Takeaways

  • The global API market is driven by the growing demand for pharmaceutical drugs, advancements in biologics and biosimilars, and the shift toward generic medicines.
  • Synthetic APIs and innovative APIs are the leading segments, driven by the demand for generic drugs and novel therapeutic agents.
  • CDMOs are crucial in the API market, offering outsourced services that help reduce production costs and enhance profitability.
  • Technological advancements, including HTS, computational drug design, and AI, are transforming the market.
  • The expiry of key biologic patents and the rising focus on targeted therapies and personalized medicine are driving market growth.

FAQs

Q: What is the projected growth rate of the global active pharmaceutical ingredients market from 2025 to 2030? A: The global active pharmaceutical ingredients market is projected to grow at a CAGR of 5.85% from 2025 to 2030[1].

Q: Which region dominated the API market in 2024? A: North America dominated the API market with the largest revenue share of 38.04% in 2024[1].

Q: What are the key drivers of the API market growth? A: The key drivers include the growing demand for pharmaceutical drugs, advancements in biologics and biosimilars, and the shift toward generic medicines[1].

Q: How are technological advancements impacting the API market? A: Technological advancements such as HTS, computational drug design, and the integration of AI and machine learning are accelerating drug discovery and development processes[3].

Q: What is the significance of CDMOs in the API market? A: CDMOs are crucial in offering outsourced services that help pharmaceutical companies reduce production costs and enhance profitability, particularly in the synthetic API segment[1].

Cited Sources

  1. Grand View Research: "Active Pharmaceutical Ingredients Market Size Report, 2030"[1].
  2. GlobeNewswire: "Small Molecule Drug Discovery Market Research Report 2024-2030"[3].
  3. MIT Sloan: "The Regulation of Prescription Drug Competition and Market Dynamics"[4].

More… ↓

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