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

Last Updated: December 23, 2024

PHENOBARBITAL SODIUM - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for phenobarbital sodium and what is the scope of patent protection?

Phenobarbital sodium is the generic ingredient in one branded drug marketed by Sun Pharm Inds Inc and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Phenobarbital sodium has two patent family members in one country.

There are three drug master file entries for phenobarbital sodium. One supplier is listed for this compound.

Summary for PHENOBARBITAL SODIUM
International Patents:2
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 3
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 31
Clinical Trials: 13
Patent Applications: 2,289
What excipients (inactive ingredients) are in PHENOBARBITAL SODIUM?PHENOBARBITAL SODIUM excipients list
DailyMed Link:PHENOBARBITAL SODIUM at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PHENOBARBITAL SODIUM
Generic Entry Date for PHENOBARBITAL SODIUM*:
Constraining patent/regulatory exclusivity:
TREATMENT OF NEONATAL SEIZURES IN TERM AND PRETERM INFANTS
Dosage:
POWDER;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for PHENOBARBITAL SODIUM

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

SponsorPhase
Kingston Health Sciences CentrePhase 1/Phase 2
Bruyere Research InstitutePhase 1/Phase 2
Ottawa Hospital Research InstitutePhase 1/Phase 2

See all PHENOBARBITAL SODIUM clinical trials

US Patents and Regulatory Information for PHENOBARBITAL SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Inc SEZABY phenobarbital sodium POWDER;INTRAVENOUS 215910-001 Nov 17, 2022 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds Inc SEZABY phenobarbital sodium POWDER;INTRAVENOUS 215910-001 Nov 17, 2022 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

PHENOBARBITAL SODIUM Market Analysis and Financial Projection Experimental

Phenobarbital Sodium Market Dynamics and Financial Trajectory

Market Size and Growth Projections

The phenobarbital market is poised for significant growth over the next several years. As of 2023, the global phenobarbital market is estimated to be valued at approximately US$ 1.58 billion and is projected to reach US$ 2.23 billion by 2030, exhibiting a compound annual growth rate (CAGR) of 5% from 2023 to 2030[1].

Another estimate suggests that the market size was valued at USD 1.48 billion in 2022 and is predicted to reach USD 2.20 billion by 2031, growing at a CAGR of 4.6% during the forecast period from 2023 to 2031[4].

Key Drivers of Market Growth

Several factors are driving the growth of the phenobarbital market:

Increasing Prevalence of Epilepsy and Seizure Disorders

The rising prevalence of epilepsy and other seizure disorders globally is a significant driver. Phenobarbital remains a first-line treatment for epilepsy, especially in developing countries where it is affordable and accessible[1][3][4].

Affordability and Effectiveness

Phenobarbital's long history of use as a potent sedative and antiepileptic drug, coupled with its affordability and effectiveness, continues to make it a mainstay in the management of epilepsy and seizures. This is particularly important in regions with limited access to newer therapies[1][3].

Growing Elderly Population

An increasing elderly population is also driving demand, as older adults are more susceptible to seizures. This demographic shift is expected to continue fueling the market growth[1].

Market Restraints and Challenges

Despite the positive growth trajectory, there are several challenges that could hamper the market:

Addiction Potential and Adverse Effects

Phenobarbital has a high potential for addiction and overdose, which is a significant concern. Additionally, side effects such as drowsiness and vertigo can deter some patients and healthcare providers[1][4].

Strict Regulations

Many countries have tightened regulations on the prescription of phenobarbital due to its high addiction potential, which could limit market growth[1].

Competition from Newer Medications

The availability of newer antiepileptic drugs with potentially fewer side effects and better safety profiles could also impact the market for phenobarbital. However, phenobarbital's established use and cost-effectiveness continue to support its market position[1][3].

Regional Insights

The phenobarbital market is geographically diverse, with different regions presenting unique opportunities and challenges:

North America

North America dominates the phenobarbital market and is expected to remain the largest regional market. The high incidence of traumatic brain injuries and well-developed healthcare infrastructure are key factors driving this dominance[1][4].

Asia Pacific

The Asia Pacific region presents lucrative opportunities due to its large patient population and improving access to healthcare. Countries like India and China, with their healthcare initiatives, are boosting the regional demand for phenobarbital[1].

Product and Dosage Forms

The market is segmented based on various product and dosage forms:

Tablets

The tablet segment is expected to grow rapidly due to its ease of administration, particularly for geriatric patients. Tablets are easier to handle and more comfortable to administer compared to injectables[4].

Injectables and Oral Suspensions

Phenobarbital is also available in injectable and oral suspension forms. The injectable form is used for intramuscular or slow intravenous administration, particularly in acute settings such as status epilepticus[5].

Distribution Channels

The distribution of phenobarbital occurs through various channels:

Hospital Pharmacies

Hospital pharmacies are a significant distribution channel, especially for acute care settings where phenobarbital is often used to manage seizures and status epilepticus[4].

Retail Pharmacies and Online Pharmacies

Retail and online pharmacies also play a crucial role, especially for long-term management of epilepsy and other neurological conditions[4].

Market Opportunities

Despite the challenges, there are several opportunities for growth and innovation in the phenobarbital market:

Research and Development

Ongoing research into new applications and formulations of phenobarbital keeps it relevant in therapeutic practices. Developing analogue drugs with lower side effects and improving delivery forms could further enhance market growth[1][3].

Emerging Markets

The possibility of expanding into emerging markets, particularly in regions with limited access to newer therapies, presents significant growth opportunities[4].

Key Players

The phenobarbital market is competitive, with several key players:

Sanofi, Pfizer Inc., Novartis AG

Companies like Sanofi, Pfizer Inc., and Novartis AG are major players in the market. Other notable companies include Teva Pharmaceutical Industries Ltd., Sun Pharmaceutical Industries Ltd., Hikma Pharmaceuticals, and Cipla Ltd.[1][4].

Financial Trajectory

The financial trajectory of the phenobarbital market is positive, driven by increasing demand and expanding market segments:

Revenue Growth

The market is expected to grow from US$ 1.58 billion in 2023 to US$ 2.23 billion by 2030, and from USD 1.48 billion in 2022 to USD 2.20 billion by 2031, reflecting a steady increase in revenue over the forecast period[1][4].

Investment Opportunities

Investments in improving agriculture and production techniques, as well as in research and development, could help overcome restraints associated with limited raw material supplies and adverse effects, further supporting the financial growth of the market[1].

Key Takeaways

  • The global phenobarbital market is projected to grow significantly, driven by the increasing prevalence of epilepsy and seizure disorders.
  • Affordability and effectiveness in managing epilepsy make phenobarbital a mainstay in many regions.
  • North America and Asia Pacific are key regions driving market growth.
  • The market faces challenges such as addiction potential, adverse effects, and strict regulations.
  • Opportunities exist in emerging markets and through research into new formulations and delivery forms.

Frequently Asked Questions (FAQs)

Q: What is the current market size of the phenobarbital market? A: As of 2023, the global phenobarbital market is estimated to be valued at approximately US$ 1.58 billion[1].

Q: What is the expected growth rate of the phenobarbital market? A: The market is expected to grow at a CAGR of 5% from 2023 to 2030[1].

Q: Which region dominates the phenobarbital market? A: North America dominates the phenobarbital market and is expected to remain the largest regional market[1][4].

Q: What are the main challenges facing the phenobarbital market? A: The main challenges include the high potential for addiction and overdose, adverse effects such as drowsiness and vertigo, and strict regulations on its prescription[1][4].

Q: Which companies are key players in the phenobarbital market? A: Key players include Sanofi, Pfizer Inc., Novartis AG, Teva Pharmaceutical Industries Ltd., and others[1][4].

Citations

  1. Coherent Market Insights: Phenobarbital Market Size, Trends and Forecast to 2030.
  2. FDA: 215910Orig1s000 OTHER REVIEW(S).
  3. Market Research Intellect: Phenobarbital Market Size, Share & Trends | Growth, 2031.
  4. InsightAce Analytic: Phenobarbital Market Latest Trends and Future Scope.
  5. DailyMed: Phenobarbital Sodium Injection, USP CIV FOR IM OR SLOW IV.

More… ↓

⤷  Subscribe

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.