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

Last Updated: March 13, 2025

DILANTIN Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Dilantin, and what generic alternatives are available?

Dilantin is a drug marketed by Viatris, Parke Davis, and Pharmacia. and is included in four NDAs.

The generic ingredient in DILANTIN is phenytoin. There are twenty-one drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the phenytoin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dilantin

A generic version of DILANTIN was approved as phenytoin by TARO on March 8th, 2004.

  Try for Free

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for DILANTIN?
  • What are the global sales for DILANTIN?
  • What is Average Wholesale Price for DILANTIN?
Drug patent expirations by year for DILANTIN
Drug Prices for DILANTIN

See drug prices for DILANTIN

Drug Sales Revenue Trends for DILANTIN

See drug sales revenues for DILANTIN

Recent Clinical Trials for DILANTIN

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

SponsorPhase
Bristol-Myers SquibbPhase 1
Lawson Health Research InstitutePhase 4
UCB Pharma GmbHPhase 4

See all DILANTIN clinical trials

US Patents and Regulatory Information for DILANTIN

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Viatris DILANTIN phenytoin sodium CAPSULE;ORAL 084349-001 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Viatris DILANTIN phenytoin sodium CAPSULE;ORAL 084349-002 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Pharmacia DILANTIN phenytoin TABLET, CHEWABLE;ORAL 084427-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Try for Free ⤷  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
Showing 1 to 3 of 3 entries

Market Dynamics and Financial Trajectory for the Drug: Dilantin

Introduction to Dilantin

Dilantin, also known as phenytoin sodium, is a widely used antiepileptic medication prescribed to treat or prevent certain types of seizures in adults and children. Understanding the market dynamics and financial trajectory of Dilantin is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Size and Growth

The global epilepsy market, which includes Dilantin, has grown into a multi-billion-dollar enterprise. The demand for antiepileptic drugs like Dilantin continues to rise, driven by the increasing prevalence of epilepsy and the need for effective treatment options. The global market for phenytoin is expected to grow at a significant CAGR from 2023 to 2030, indicating a robust market demand[1].

Key Players

The market for Dilantin is dominated by several major pharmaceutical companies, including:

  • Actavis Mid Atlantic LLC
  • Pfizer Pharmaceuticals Ltd
  • Sun Pharmaceutical Industries Ltd
  • Wockhardt Ltd
  • Watson Laboratories Inc
  • Pharmeral Inc
  • App Pharmaceuticals LLC
  • Baxter Healthcare Corp
  • Hospira Inc
  • Mylan Pharmaceuticals Inc
  • Pliva Inc[1].

These companies play a significant role in the production, distribution, and marketing of Dilantin, influencing its market dynamics.

Financial Performance of Key Players

Pfizer, one of the major players in the Dilantin market, has shown significant financial performance over the years. In 2020, Pfizer reported net income of $3.401 billion, with substantial investments in research and development and a strong portfolio of pharmaceutical products[2].

Cost and Pricing Factors

The cost of Dilantin can vary significantly based on several factors:

  • Treatment Plan: The dosage and duration of the treatment plan can affect the overall cost.
  • Insurance Coverage: The extent of insurance coverage and specific plan benefits can influence the out-of-pocket expenses.
  • Pharmacy: The choice of pharmacy can also impact the price.
  • Form of the Drug: Dilantin is available in various forms, including extended-release oral capsules, chewable tablets, and liquid suspension, each with different pricing[4].

Brand Name vs. Generic

Dilantin, being a brand-name drug, is generally more expensive than its generic counterpart, phenytoin. Generic versions of phenytoin are available once the patent for the brand-name drug expires, leading to increased competition and potentially lower costs. The generic versions contain the same active ingredients and are considered as safe and effective as the brand-name drug[4].

Financial Assistance and Savings Programs

To make Dilantin more affordable, various financial assistance and savings programs are available:

  • Optum Perks Coupons: These coupons can help reduce the cost of Dilantin, especially for those without insurance.
  • Patient Assistance Programs: Many pharmaceutical companies offer patient assistance programs to help patients afford their medications.
  • 90-Day Supply: Getting a 90-day supply of Dilantin, if approved by the insurance company, can reduce the number of pharmacy visits and lower costs[4].

Legal and Litigation Costs

Dilantin has been associated with several lawsuits, particularly related to severe side effects such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). These lawsuits have resulted in significant financial liabilities for the manufacturers. For example, in 2010, Pfizer was ordered to pay $10 million to a patient suffering from SJS and cerebellar shrinkage, and $3.78 million to the family of a nine-year-old girl who died after ingesting Dilantin[3].

Market Trends and Future Outlook

The market for Dilantin is expected to continue growing due to several factors:

  • Increasing Prevalence of Epilepsy: The rising number of epilepsy cases globally drives the demand for antiepileptic medications.
  • Generic Competition: The availability of generic versions of phenytoin will continue to influence pricing and market dynamics.
  • Innovative Distribution Strategies: Pharmaceutical companies are expanding their sales and distribution footprints to reach more patients, which can impact the market trajectory[5].

Regulatory Impact

Changes in regulatory policies, such as the revision of the National List of Essential Medicines (NELM), can significantly impact the pricing and volume sales of essential drugs, including Dilantin. For instance, price reductions due to regulatory changes can lead to volume growth opportunities for pharmaceutical companies[5].

Environmental and Sustainability Initiatives

Pharmaceutical companies, including those producing Dilantin, are increasingly focusing on sustainability initiatives. For example, Pfizer Limited has implemented green energy projects, with approximately 38% of the total energy demand for their manufacturing operations coming from renewable sources[5].

Key Takeaways

  • Growing Market Demand: The global market for phenytoin is expected to grow significantly due to the increasing prevalence of epilepsy.
  • Cost Factors: The cost of Dilantin varies based on treatment plans, insurance coverage, pharmacy choice, and the form of the drug.
  • Brand Name vs. Generic: Generic versions of phenytoin are generally cheaper and equally effective.
  • Financial Assistance: Various savings programs and patient assistance initiatives are available to make Dilantin more affordable.
  • Legal and Litigation Costs: Manufacturers face significant financial liabilities due to lawsuits related to severe side effects.
  • Market Trends: The market is influenced by generic competition, innovative distribution strategies, and regulatory changes.

FAQs

Q: What are the main factors affecting the cost of Dilantin? A: The cost of Dilantin is affected by the treatment plan, insurance coverage, pharmacy choice, and the form of the drug.

Q: How does the cost of Dilantin compare to its generic counterpart? A: Dilantin, being a brand-name drug, is generally more expensive than its generic counterpart, phenytoin.

Q: What financial assistance programs are available for Dilantin? A: Various financial assistance programs, including Optum Perks coupons and patient assistance programs, are available to make Dilantin more affordable.

Q: What are some of the severe side effects associated with Dilantin? A: Dilantin has been associated with severe side effects such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).

Q: How do regulatory changes impact the market for Dilantin? A: Regulatory changes, such as revisions to the National List of Essential Medicines, can lead to price reductions and volume growth opportunities for pharmaceutical companies.

Sources

  1. Global Phenytoin Market Research Report 2024 - Valuates Reports
  2. United States Securities and Exchange Commission - Form 10-Q - Pfizer
  3. Dilantin Lawsuits - Miller and Zois
  4. Cost and Dilantin: Financial assistance options, savings, more - Medical News Today
  5. Annual Report 2023 – 24 - Pfizer Limited

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.