BILTRICIDE Drug Patent Profile

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Which patents cover Biltricide, and when can generic versions of Biltricide launch?

Biltricide is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in BILTRICIDE is praziquantel. Two suppliers are listed for this compound. Additional details are available on the praziquantel profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Biltricide

A generic version of BILTRICIDE was approved as praziquantel by PH HEALTH on November 27^th, 2017.

Summary for BILTRICIDE

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for BILTRICIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	BILTRICIDE	praziquantel	TABLET;ORAL	018714-001	Dec 29, 1982		DISCN	Yes	No

International Patents for BILTRICIDE

See the table below for patents covering BILTRICIDE around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	208527	PROCEDIMIENTO PARA LA PREPARACION DE 2-ACIL-4-OXO-POLIHIDRO-PIRAZINO(2,1-A)ISOQUINOLINAS
Argentina	208715	PROCEDIMIENTO PARA PREPARAR 2-ACIL-4-OXO-HEXAHIDRO-PIRAZINO(2,1-A)ISOQUINOLINAS POR CICLACION
Austria	346334
Austria	346344

Investment Scenario and Fundamentals Analysis for BILTRICIDE

Last updated: April 16, 2026

What is BILTRICIDE?

BILTRICIDE is the brand name for valproic acid, marketed by various pharmaceutical companies primarily for the treatment of epilepsy, bipolar disorder, and headache conditions. The drug was approved by the FDA in 1978. It has a long-standing presence in the anticonvulsant market, with generic versions widely available.

Market Position and Competitive Landscape

BILTRICIDE competes primarily against other antiepileptic drugs (AEDs), including:

• Lamotrigine
• Levetiracetam
• Topiramate
• Carbamazepine

The global AED market size was valued at approximately USD 4.6 billion in 2022, with a compound annual growth rate (CAGR) of 4.3% forecasted through 2030 ([1]).

Market Share Highlights:

Drug Class/Agent	Market Share (2022)	Notes
Valproic acid	23%	One of the most prescribed AEDs globally
Levetiracetam	18%	Increasing preference due to side-effect profile
Lamotrigine	15%	Used in bipolar disorder and epilepsy
Others	44%	Includes carbamazepine, topiramate, generics, etc.

Revenue and Sales Trends

BILTRICIDE's global revenues have declined over the years, aligned with the rise of newer AEDs with improved safety profiles. Overall, the drug's patent expiration in various regions has led to generic competition, limiting pricing power but increasing volume sales.

Year	Approximate Global Sales (USD millions)	Notes
2018	472	High point before generics penetration
2020	350	Decline due to generics and safer alternatives
2022	285	Continued decline, market saturation

Patent and Regulatory Status

BILTRICIDE's patent expired in the United States in 2008, prompting generic manufacturers to enter the market.

• Regulatory approvals: Approved for epilepsy, bipolar disorder, migraine prophylaxis.
• Market exclusivity: No longer under patent protection; generic versions dominate.

Fundamental Analysis

Revenue and Profitability

• Declining sales volume due to generics.
• Margins compressed; primary revenue driven by volume rather than price.
• No recent data indicating new formulations or approved variations to reassert premium pricing.

R&D and Pipeline

• No recent filings or pipeline developments specifically for BILTRICIDE.
• Focus likely shifted to novel therapies targeting refractory epilepsy and psychiatric conditions.

Therapeutic and Market Trends

• Increasing preference for drugs with better safety and tolerability.
• Growing epilepsy prevalence (~50 million globally[2]) sustains market size.
• Shift towards personalized medicine and biomarkers influencing drug choice.

Competitive Risks

• Patent expirations reduce pricing power.
• Entry of new AEDs with improved safety profiles.
• Regulatory shifts favoring drugs with fewer side effects.

Investment Consideration

• Positive factors: Established efficacy, broad indication spectrum, existing manufacturing capabilities.
• Negative factors: Market share erosion, low differentiation after patent expiration, declining revenues, patent and regulatory risks.

Valuation Outlook

Given the current competitive landscape, BILTRICIDE's prospects depend on whether it can:

• Leverage existing manufacturing infrastructure for branded or specialized formulations.
• Tap into niche markets (e.g., specific patient subsets requiring valproic acid).
• Possible licensing deals or acquisitions for formulation improvements.

However, without pipelines or significant differentiation, the asset’s valuation remains limited.

Key Takeaways

• BILTRICIDE holds a mature position within the AED market with declining revenues.
• Patent expiry and generic competition suppress pricing power.
• Market trends favor drugs with better safety and tolerability profiles.
• Investment risk remains high unless new formulations or indications emerge.
• Valuations are primarily based on existing sales volumes, not growth prospects.

FAQs

1. Is BILTRICIDE a good investment based on current data?
The drug's mature status and declining revenues suggest limited upside unless repositioned with new indications or formulations.

2. Can BILTRICIDE gain market share?
Historically difficult post-patent expiration. Market trend favors newer agents with improved safety.

3. Are there ongoing R&D efforts for BILTRICIDE?
No recent pipeline developments or new formulations publicly announced.

4. What are the main risks for investing in BILTRICIDE?
Patent expiry, generic price competition, safety profile concerns, and emergence of new therapies.

5. How does the market outlook for AEDs affect BILTRICIDE?
Growing epilepsy prevalence ensures market size, but competitive innovation favors advanced drugs, limiting BILTRICIDE’s growth opportunities.

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References

[1] MarketWatch. (2023). Global Antiepileptic Drugs Market Size, Share & Trends Analysis Report.
[2] World Health Organization. (2022). Epilepsy Fact Sheet.