RAZADYNE Drug Patent Profile

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

Razadyne is a drug marketed by Janssen Pharms and is included in three NDAs.

The generic ingredient in RAZADYNE is galantamine hydrobromide. There are fifteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Razadyne

A generic version of RAZADYNE was approved as galantamine hydrobromide by BARR on August 28^th, 2008.

Summary for RAZADYNE

US Patents:	0
Applicants:	1
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	160
Clinical Trials:	21
Patent Applications:	880
Drug Prices:	Drug price information for RAZADYNE
What excipients (inactive ingredients) are in RAZADYNE?	RAZADYNE excipients list
DailyMed Link:	RAZADYNE at DailyMed

See drug prices for RAZADYNE

Recent Clinical Trials for RAZADYNE

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

Sponsor	Phase
Vanderbilt University Medical Center	Phase 1
Vanderbilt University	Phase 1/Phase 2
Doris Duke Charitable Foundation	Phase 1/Phase 2

See all RAZADYNE clinical trials

Paragraph IV (Patent) Challenges for RAZADYNE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RAZADYNE	Tablets	galantamine hydrobromide	4 mg, 8 mg and 12 mg	021169	14	2005-02-28

US Patents and Regulatory Information for RAZADYNE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	RAZADYNE	galantamine hydrobromide	SOLUTION;ORAL	021224-001	Jun 22, 2001		DISCN	No	No
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-003	Apr 1, 2005		DISCN	Yes	No
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-003	Feb 28, 2001		DISCN	Yes	No
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-001	Feb 28, 2001		DISCN	Yes	No
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-002	Feb 28, 2001		DISCN	Yes	No

Expired US Patents for RAZADYNE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-002	Feb 28, 2001	6,358,527
Janssen Pharms	RAZADYNE	galantamine hydrobromide	SOLUTION;ORAL	021224-001	Jun 22, 2001	4,663,318
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-003	Feb 28, 2001	4,663,318
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-003	Feb 28, 2001	6,099,863
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-002	Feb 28, 2001	6,099,863

International Patents for RAZADYNE

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9747304
Japan	4172820
Japan	H08778
Slovakia	169698	FAST-DISSOLVING GALANTHAMINE HYDROBROMIDE TABLET
Czech Republic	295226	Tableta obsahující jako účinnou složku terapeuticky účinné množství hydrobromidu galantaminu a způsob její přípravy (Tablet containing a therapeutically effective amount of galanthamine hydrobromide as active component and process for its preparation)

Supplementary Protection Certificates for RAZADYNE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0236684	C00236684/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0236684	3/2001	Austria		PRODUCT NAME: GALANTAMIN ODER SAEUREADDITIONSSALZE DAVON; NAT. REGISTRATION NO/DATE: 1-23748, 1-23749, 1-23750, 1-23751 20000822; FIRST REGISTRATION: SE 15561, 15562, 15563,15565 20000301
0236684	2001C/007	Belgium		PRODUCT NAME: GALANTAMINUM HYDROBROMIDUM; NAT. REGISTRATION NO/DATE: 1028 IS 94 F3 20000918; FIRST REGISTRATION: SE 15561 20000301
0236684	SPC/GB00/033	United Kingdom		PRODUCT NAME: GALANTHAMINE OR ACID ADDITION SALTS THEREOF; REGISTERED: SE 15561 20000301; SE 15562 20000301; SE 15563 20000301; SE 15565 20000301; UK PL08557/0039 20000914; UK PL08557/0040 20000914; UK PL08557/0041 20000914; UK PL08557/0042 20000914
0236684	C300140	Netherlands		PRODUCT NAME: GALANTAMINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER GALANTAMINE HYDROBROMIDE; NAT. REGISTRATION NO/DATE: RVG 29073 - RVG 29076 20030702; FIRST REGISTRATION: SE 15561 - 15565 20000225

Market Dynamics and Financial Trajectory for RAZADYNE

Last updated: July 29, 2025

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Introduction

RAZADYNE, known generically as zaleplon, is a non-benzodiazepine sedative-hypnotic primarily used for the short-term treatment of insomnia. Originally developed by Eli Lilly and Company, zaleplon has entered a competitive pharmaceutical landscape characterized by evolving prescribing patterns, regulatory considerations, and emerging therapeutic alternatives. Analyzing RAZADYNE’s market dynamics and financial trajectory necessitates an understanding of its clinical profile, regulatory environment, market penetration, and competitive forces.

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Clinical Profile and Therapeutic Niche

RAZADYNE distinguishes itself by its rapid onset of action, typically inducing sleep within 15 minutes, and its short half-life of approximately one hour. This profile suits patients with difficulty falling asleep but not for those experiencing multiple awakenings. The drug’s pharmacokinetics, minimal next-morning residual effects, and lower dependence risks relative to benzodiazepines contributed to its initial market success.

However, the scope of its indication remains narrow, confined mostly to transient insomnia. Its safety profile and ease of discontinuation have supported its adoption, although recent concerns over complex sleep behaviors, such as sleepwalking and sleep-driving, have prompted regulatory vigilance.

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Regulatory and Patent Landscape

Eli Lilly launched RAZADYNE (zaleplon) in 1999, garnering FDA approval primarily as a Short-Term Treatment for Insomnia. Patent protections historically secured exclusivity until patent expiration in 2015, after which generic formulations entered the market, significantly eroding Lilly’s market share. The patent landscape continues to influence RAZADYNE’s financial trajectory, with exclusivity windows dictating pricing power and market control.

In recent years, regulatory reviews have intensified, especially concerning safety concerns linked to complex sleep behaviors, leading to updated prescribing information. These regulatory shifts influence both physician prescribing practices and market uptake among new patients.

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Market Penetration and Competitive Dynamics

Post-generic market entry, RAZADYNE faces stiff competition from both branded and generic alternatives. Notably, other sleep aids such as zolpidem (Ambien), eszopiclone (Lunesta), and newer agents like suvorexant compete within the same niche.

The advent of over-the-counter remedies and non-pharmacologic interventions, including cognitive behavioral therapy for insomnia (CBT-I), also impacts prescription volumes. Insurance formularies and cost considerations favor generics, pressuring RAZADYNE’s sales volumes.

However, niche therapeutic positioning, particularly among patients intolerant to other agents, maintains residual demand. Additionally, some clinicians prefer zaleplon for its minimal residual sedation, fostering continued, albeit limited, prescribing.

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Pharmaceutical Financial Trajectory

Historical Revenue Trends

In the early 2000s, RAZADYNE contributed significantly to Eli Lilly’s sleep disorder franchise, with peak revenues approaching hundreds of millions annually. However, patent expiry and emerging competition caused sales to decline markedly, with estimates suggesting a drop from over $300 million pre-2015 to minimal figures post-generic entry.

Post-Patent Strategy and Generic Competition

Following patent expiration, Lilly’s revenue attributable to zaleplon dwindled as generic manufacturers introduced cost-effective alternatives. The company’s focus shifted towards diversifying its portfolio, reducing reliance on older sleep aids.

Licensing and Distribution

Some pharmaceutical companies license zaleplon formulations or utilize alternative marketing channels to sustain sales. However, most revenues now derive from legacy product sales rather than growth segments.

Future Financial Outlook

Given patent expiry and legal challenges, the future revenue stream for RAZADYNE remains subdued. Innovative repositioning or combination therapies could carve out niche markets but are unlikely to reverse the overall declining trend.

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Market Trends and Forecasts

Shift Toward Non-Pharmacologic Treatments

The increasing adoption of CBT-I and behavioral interventions reduces dependency on pharmacotherapy, constraining growth prospects for RAZADYNE. The market is forecasted to prioritize therapies with demonstrated long-term safety and efficacy.

Regulatory and Safety Influence

Enhanced FDA surveillance over sleep aids influences prescribing practices. Increased safety warnings diminish RAZADYNE’s attractiveness, particularly with reports of complex sleep behaviors. Such issues could lead to further market contraction.

Emerging Technologies and Alternatives

Technological advances, including digital therapeutics and mobile health apps addressing sleep disturbances, threaten traditional pharmacological markets. These alternatives target the same patient demographic with non-invasive options, further impacting RAZADYNE’s market share.

Forecast Summary

The market for zaleplon is expected to continue contracting over the next five years. Limited future growth hinges on developing novel formulations, targeted marketing to specific patient subsets, or repositioning as part of combination protocols. Overall, the financial trajectory indicates a declining revenue landscape, with minimal prospects for significant recovery absent strategic innovations.

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Competitive Environment Analysis

Company	Product Emphasis	Market Position	Innovation Initiatives
Pfizer	Zolpidem (Ambien)	Market leader in sleep aids	Developing next-gen sleep therapeutics
Takeda	Eszopiclone (Lunesta)	Significant share; focus on long-term use	Exploring combination formulations
Belsomra (suvorexant)	Merck	Novel orexin receptor antagonist	Broadening indications and formulations
Generic Manufacturers	Zaleplon generics	Dominant in price-sensitive markets	Cost leadership, expanding distribution

The competitive landscape emphasizes dose convenience, safety profiles, and regulatory acceptance. RAZADYNE’s niche positioning faces erosion amid innovations and shifting prescribing behaviors.

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Legal and Patent Strategies

To sustain some revenue, Eli Lilly and other stakeholders have pursued patent extensions and legal protections. Nevertheless, generic competition overwhelmingly diminishes exclusivity-driven margins. Patent cliffs, typically 20-year periods from filing, heavily influence the decline trajectory.

With patent expirations in 2015, and no subsequent new chemical entities (NCEs) launched under the same class, the outlook remains bleak unless new formulations or delivery systems are developed.

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Impact of COVID-19 on Market Dynamics

The pandemic heightened sleep disturbances, increasing demand for sleep therapeutics temporarily. However, economic uncertainties and regulatory shifts led to cautious prescribing. The long-term impact likely favors non-prescription options or behavioral therapies, further constraining zaleplon’s market prospects.

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Key Takeaways

• Exhausted Patent Life: Patent expiry in 2015 precipitated a sharp decline in RAZADYNE revenues, with generics dominating sales.
• Competitive Headwinds: Saturated market with entrenched brands like Ambien and newer agents dampens growth prospects.
• Regulatory and Safety Caveats: Safety concerns and regulatory updates diminish physician prescribing, affecting adoption.
• Market Shift Toward Non-Pharmacologic Therapies: Increasing emphasis on behavioral treatments limits pharmacotherapy's share.
• Limited Innovation Drive: Lack of new formulations or indications constrains potential market resurgence.

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FAQs

1. What are the primary factors impacting RAZADYNE’s market performance?
   Patent expiration, generic competition, safety concerns, and a shift toward non-pharmacologic therapies primarily influence its declining sales.

2. Can RAZADYNE regain market share through new formulations or indications?
   Given the limited pipeline and significant competition, only innovative formulations or new approved indications could revive sales—a scenario unlikely without substantial R&D investment.

3. How does regulatory safety information affect the prescription of zaleplon?
   Safety warnings about complex sleep behaviors lead to cautious prescribing, reducing its market penetration relative to more established or perceived safer alternatives.

4. What market trends could influence RAZADYNE’s future?
   The growth of digital sleep aids, behavioral therapies, and personalized medicine approaches pose ongoing threats to zaleplon’s relevance.

5. Are there any geographic markets where zaleplon remains profitable?
   Emerging markets with less stringent regulatory oversight and limited access to newer therapies may sustain niche sales temporarily.

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Conclusion

RAZADYNE’s market and financial landscape exemplify the lifecycle of a branded pharmaceutical drug post-patent expiry. The confluence of patent expiration, intense competition, regulatory concerns, and evolving treatment paradigms has led to a significant decline in its commercial viability. Future prospects hinge on strategic innovation or repositioning within the broader sleep therapeutics market.

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References

[1] U.S. Food and Drug Administration. “Zaleplon (RAZADYNE) Drug Label.” 2005.
[2] Eli Lilly and Company. “Annual Reports and Financial Statements.” 2010-2022.
[3] Market research reports on sleep aids and sedative-hypnotic medications.
[4] Regulatory updates on sleep medication safety advisories.
[5] Industry analyses on patent expiry impacts and generic competition trends.