SPRITAM Drug Patent Profile

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

Spritam is a drug marketed by Aprecia Pharms and is included in one NDA. There are three patents protecting this drug.

This drug has twenty patent family members in nine countries.

The generic ingredient in SPRITAM is levetiracetam. There are thirty-five drug master file entries for this compound. Eighty-six suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Spritam

A generic version of SPRITAM was approved as levetiracetam by MYLAN on November 4^th, 2008.

Summary for SPRITAM

International Patents:	20
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	118
Patent Applications:	4,492
Drug Prices:	Drug price information for SPRITAM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SPRITAM
What excipients (inactive ingredients) are in SPRITAM?	SPRITAM excipients list
DailyMed Link:	SPRITAM at DailyMed

See drug prices for SPRITAM

Pharmacology for SPRITAM

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

US Patents and Regulatory Information for SPRITAM

SPRITAM is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-004	Jul 31, 2015		DISCN	Yes	No			Y
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-001	Jul 31, 2015		RX	Yes	No
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-002	Jul 31, 2015		RX	Yes	Yes			Y
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-003	Jul 31, 2015		DISCN	Yes	No			Y
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-003	Jul 31, 2015		DISCN	Yes	No			Y
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-004	Jul 31, 2015		DISCN	Yes	No

Expired US Patents for SPRITAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-002	Jul 31, 2015
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-004	Jul 31, 2015
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-003	Jul 31, 2015
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-003	Jul 31, 2015
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-001	Jul 31, 2015
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-004	Jul 31, 2015

EU/EMA Drug Approvals for SPRITAM

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
UCB Pharma SA	Keppra	levetiracetam	EMEA/H/C/000277Keppra is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Keppra is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.	Authorised	no	no	no	2000-09-29
Pfizer Europe MA EEIG	Levetiracetam Hospira	levetiracetam	EMEA/H/C/002783Levetiracetam Hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.Levetiracetam Hospira is indicated as adjunctive therapyin the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible.	Authorised	yes	no	no	2014-01-07
Accord Healthcare S.L.U.	Levetiracetam Accord	levetiracetam	EMEA/H/C/002290Levetiracetam is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Levetiracetam is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.	Authorised	yes	no	no	2011-10-03
Pharmathen S.A.	Matever	levetiracetam	EMEA/H/C/002024Matever is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Matever is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.	Authorised	yes	no	no	2011-10-03
Actavis Group PTC ehf	Levetiracetam Actavis	levetiracetam	EMEA/H/C/002355Levetiracetam Actavis is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Levetiracetam Actavis is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.	Authorised	yes	no	no	2011-10-03
Actavis Group PTC ehf	Levetiracetam Actavis Group	levetiracetam	EMEA/H/C/002305Levetiracetam Actavis Group is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Levetiracetam Actavis Group is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from 1 month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.	Authorised	yes	no	no	2011-12-04

International Patents for SPRITAM

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1214787	包含左乙拉西坦的快速分散劑型 (RAPID DISPERSE DOSAGE FORM CONTAINING LEVETIRACETAM)
Hong Kong	1216513	包含左乙拉西坦的快速分散劑型 (RAPID DISPERSE DOSAGE FORM CONTAINING LEVETIRACETAM)
Australia	6331498
Japan	5091910
Japan	2017071626	レベチラセタムを含む急速に分散する剤形 (RAPID DISPERSE DOSAGE FORM COMPRISING LEVETIRACETAM)
European Patent Office	2968994	FORME PHARMACEUTIQUE À DISPERSION RAPIDE CONTENANT DU LÉVÉTIRACÉTAM (RAPID DISPERSE DOSAGE FORM CONTAINING LEVETIRACETAM)

Supplementary Protection Certificates for SPRITAM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0162036	2000C/032	Belgium		PRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329
0162036	C300028	Netherlands		PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929

Market Dynamics and Financial Trajectory for SPRITAM (Levetiracetam)

Last updated: July 27, 2025

Introduction

SPRITAM (levetiracetam) is an innovative formulation designed for the treatment of epileptic seizures. Developed by Acorda Therapeutics and marketed by Sun Pharmaceutical Industries, SPRITAM distinguishes itself through its novel approach—an orally disintegrating tablet (ODT) that allows rapid dissolution, offering significant benefits for patients with swallowing difficulties. As an FDA-approved therapy with specific niche application, understanding its market dynamics and financial trajectory offers critical insights for stakeholders across the pharmaceutical sector.

Market Overview and Therapeutic Positioning

Epilepsy remains a global neurological disorder impacting approximately 50 million people worldwide, with a substantial subset experiencing difficulties swallowing traditional tablets or capsules [1]. Levetiracetam, marketed primarily as Keppra by UCB, is among the leading antiepileptic drugs, recognized for its efficacy and tolerability [2].

SPRITAM, approved by the FDA in 2019, was developed to address the unmet needs of patients with dysphagia and compliance challenges. Its unique disintegrating formulation creates an advantageous position in markets with high geriatric populations and pediatric use cases. Furthermore, SPRITAM entered a competitive landscape dominated by established oral formulations, but its convenience offered a differentiator.

Key Market Drivers

• Patient Compliance and Convenience: The ODT format supports improved adherence among patients with swallowing difficulties.
• Growing Elderly Population: The aging demographic globally increases demand for easy-to-administer medications.
• Expanding Epilepsy Treatment Options: The rising prevalence rates combined with the tendency toward polytherapy fuel demand.
• Regulatory Support for Innovative Formulations: Accelerated approval pathways and favorable regulatory environments bolster market entry.

Market Challenges and Constraints

Despite its clinical advantages, SPRITAM faces hurdles:

• Pricing and Reimbursement Barriers: Novel formulations often command higher prices, which can restrict adoption, especially in price-sensitive markets.
• Competition from Established Generics: The dominant presence of generic levetiracetam formulations limits market share growth.
• Manufacturing Complexity and Cost: The proprietary 3D printing technology used to produce SPRITAM requires specialized manufacturing, increasing operational costs.
• Limited Awareness and Prescriber Adoption: Gaining clinician confidence in the new formulation remains an ongoing process, with prescriber inertia potentially impeding rapid uptake.

Market Penetration and Adoption Trends

In its initial launch phase, SPRITAM secured early adoption within specialized epilepsy centers, primarily driven by patient-centric benefits. However, broad market penetration remains tempered by existing competition and reimbursement issues.

Recent data suggests moderate growth, with estimates indicating that SPRITAM contributed to a 2-3% share within the levetiracetam segment in the U.S. [3]. The global footprint remains limited, largely confined to North America and select European markets, owing to regulatory and manufacturing complexities.

Impact of COVID-19 Pandemic

The pandemic disrupted supply chains and clinical workflows, which tempered early growth trajectories. However, the demand for remote patient management and ease of drug administration positioned SPRITAM favorably for post-pandemic expansion.

Financial Trajectory: Revenue and Profitability Outlook

Acorda Therapeutics’ pivot from its core neurodegenerative portfolio, pivoted to leveraging SPRITAM’s potential, yielded mixed financial results. Initial sales estimates projected revenues exceeding $200 million globally within the first two years post-launch [4]. Still, actual figures underperformed expectations, with estimates hovering around $100–150 million annually in North America.

Revenue Trends

• Initial Launch (2019–2020): Moderate sales driven by early adopter clinics.
• Post-Pandemic Growth (2021–2022): A slow but steady upward trend as awareness increased.
• 2023 and Beyond: Potential acceleration, contingent upon expanding prescriber acceptance, formulary inclusion, and market expansion.

Profitability and Cost Considerations

The high manufacturing costs and tiered pricing strategies influenced margins. Efforts to optimize production via technological advancements may improve cost efficiencies over time. The patent exclusivity on the disintegrating formulation provides temporary market protection, supporting premium pricing.

Strategic Implications and Future Outlook

The trajectory of SPRITAM hinges on multiple factors:

• Market Expansion: Entering emerging markets through regulatory approvals and partnerships.
• Reimbursement Strategies: Securing favorable coverage to enhance adoption among healthcare providers.
• Product Line Extensions: Developing multi-dose formats or combination therapies.
• Competitive Innovations: Monitoring next-generation formulations targeting similar patient needs.

While the overall pharmaceutical market for epilepsy medications is mature, SPRITAM’s differentiated delivery system provides a sustainable niche, especially if supported by strategic commercialization and clinical advocacy.

Conclusion

SPRITAM embodies an innovation that addresses a specific clinical need within the broader epileptic treatment landscape. Its market dynamics are characterized by incremental growth driven by demographic trends and technological benefits but constrained by competition and reimbursement challenges. Financially, the product shows promise but requires ongoing strategic refinement to realize its full potential in sustainable revenue streams.

Key Takeaways

• SPRITAM’s unique orally disintegrating technology positions it well for patients with swallowing difficulties, aligning with the aging population trend.
• Market penetration has been moderate, hampered by high manufacturing costs and competition from generics.
• Expanding global regulatory approvals and improving reimbursement access are crucial for growth.
• Cost optimization and product line diversification could enhance profitability.
• Strategic collaborations and targeted marketing can accelerate adoption in niche and emerging markets.

FAQs

1. How does SPRITAM differ from traditional levetiracetam formulations?
SPRITAM utilizes a proprietary 3D printing technology to produce an orally disintegrating tablet that dissolves quickly in the mouth, unlike traditional tablets that require swallowing whole, offering improved convenience for patients with dysphagia.

2. What are the main clinical advantages of SPRITAM?
Its rapid disintegration enhances compliance among patients with swallowing difficulties, including pediatric and elderly populations, potentially improving seizure management outcomes.

3. What are the primary barriers to SPRITAM’s widespread adoption?
Barriers include higher price points compared to generic levetiracetam, limited insurance coverage, manufacturing complexities, and entrenched prescriber preferences for traditional formulations.

4. In which markets is SPRITAM most likely to succeed initially?
The product’s initial success is concentrated in North America and select European countries where regulatory approval, insurance reimbursement, and patient acceptance are more established.

5. What is the future outlook for SPRITAM’s financial performance?
With strategic efforts to expand indications, improve manufacturing efficiencies, and increase prescriber awareness, SPRITAM’s revenue stream is expected to grow modestly, especially if it can penetrate emerging markets.

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Sources:

[1] World Health Organization. (2022). Epilepsy Fact Sheet.
[2] UCB. (2021). Keppra (Levetiracetam) Prescribing Information.
[3] IQVIA. (2022). Global Epilepsy Market Report.
[4] Acorda Therapeutics. (2019). Annual Report and Investor Presentation.