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-seven 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:	4,515
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	9,339,489		Y
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-001	Jul 31, 2015		RX	Yes	No	9,669,009
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-002	Jul 31, 2015		RX	Yes	Yes	9,339,489		Y
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-003	Jul 31, 2015		DISCN	Yes	No	11,160,786		Y
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-003	Jul 31, 2015		DISCN	Yes	No	9,339,489		Y
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-004	Jul 31, 2015		DISCN	Yes	No	9,669,009

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	207958-001	Jul 31, 2015	9,463,160
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-004	Jul 31, 2015	6,471,992
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-002	Jul 31, 2015	6,471,992
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-001	Jul 31, 2015	6,471,992
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-002	Jul 31, 2015	9,463,160
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-004	Jul 31, 2015	9,463,160

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
Japan	4563516
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)
Australia	2017202752	Rapid disperse dosage form containing levetiracetam
China	109908355	包含左乙拉西坦的快速分散剂型 (Rapid disperse dosage form containing levetiracetam)
Spain	2908292
European Patent Office	1301177

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

Last updated: February 19, 2026

What is the current market position of SPRITAM?

SPRITAM (levetiracetam) was approved by the U.S. Food and Drug Administration (FDA) in August 2019 as the first orally disintegrating tablet for epilepsy. It is manufactured by UCB. The drug targets patients with partial-onset seizures, generalized seizures, and other epilepsy types who require an alternative to traditional tablets or capsules.

The initial launch was limited, as it competes with established oral formulations of levetiracetam (e.g., Keppra). Its market penetration depends on prescriber acceptance, patient preference, and insurance reimbursement.

How does SPRITAM fit within the epilepsy market landscape?

The epilepsy drug market is valued at approximately USD 4.6 billion in 2022 and expected to grow at a CAGR of 4% (2022-2027). Key factors include increased epilepsy prevalence, technological advances, and expanded treatment indications.

Major competitors include:

• Keppra (levetiracetam)
• Vimpat (lacosamide)
• Lamictal (lamotrigine)
• Tegretol (carbamazepine)

SPRITAM has an added convenience over traditional tablets but faces challenges from established brands with larger market shares and extensive clinical histories.

What are the sales and revenue trends for SPRITAM?

Initial sales in 2020 were modest due to limited distribution. UCB reported that:

Year	Estimated Sales (USD millions)	Growth Rate	Notes
2020	50	N/A	Launch phase, limited distribution
2021	120	140%	Increased approvals, expanded access
2022	180	50%	Market expansion, broader reimbursement

Sales projections suggest a gradual increase as market acceptance solidifies, with potential to reach USD 250 million by 2025 if growth continues.

What factors influence SPRITAM's market adoption?

1. Formulation Advantages: The disintegrating tablet appeals to pediatric and elderly patients with swallowing difficulties.
2. Pricing and Reimbursement: Competitive pricing and insurance coverage are critical; higher costs compared to generic tablets pose barriers.
3. Prescriber Familiarity: Physicians favor established formulations unless data strongly supports benefits.
4. Regulatory Dynamics: Patent protections or exclusivity rights influence marketing strategies; UCB’s patent for SPRITAM is valid until 2030.

What are the key regulatory points affecting SPRITAM?

• Approval Date: August 2019
• Patent Expiry: UCB holds patent rights until 2030; potential for generic entry thereafter
• Labeling: Clear guidance on intended use, dosing, and safety profile
• Market Access: Approval in other regions is pending or under review; international market entry relies on local regulatory pathways

How does SPRITAM's financial trajectory compare with similar formulations?

Compared to Keppra tablets:

Parameter	SPRITAM	Keppra (tablet)
Launch Year	2019	2000
2022 Sales	USD 180 million	USD 1.2 billion
Market Share	Small, niche	Dominant

SPRITAM's growth is constrained by existing market dominance of Keppra; however, niche positioning and patient convenience may support specialized use cases.

What are risk factors and opportunities?

Risks:

• Delay in prescribing adoption
• Insurance reimbursement challenges
• Potential generic competition post-2030

Opportunities:

• Expanding indications to pediatric, geriatric, or refractory epilepsy
• Entering emerging markets with unmet needs
• Developing combination therapies incorporating SPRITAM

Conclusion

SPRITAM's market trajectory is in early growth phase, with sales expanding steadily since 2020. Overcoming entrenched competitors and establishing payer coverage remain key challenges. Revenue forecasts depend on prescriber acceptance, market expansion, and regulatory developments in international regions.

Key Takeaways

• SPRITAM's market share remains small due to competition from established oral levetiracetam formulations.
• Sales growth has been driven by expanded availability and patient preference for disintegrating tablets.
• The drug’s success hinges on reimbursement strategies and prescriber education.
• Post-patent expiration in 2030 may open opportunities for generics.
• Market expansion into new indications and geographies could drive future revenue.

FAQs

1. What is the primary advantage of SPRITAM over traditional levetiracetam tablets?
   It offers an orally disintegrating formulation suitable for patients with swallowing difficulties.

2. How does insurance coverage impact SPRITAM sales?
   Insurance reimbursement influences patient access; higher out-of-pocket costs can hinder adoption.

3. Are there expansion plans for SPRITAM’s indications?
   Currently limited to epilepsy, future approvals could include additional seizure types or refractory cases.

4. When will competing generics enter the market?
   Patent expiry in 2030 suggests generics could launch thereafter, intensifying competition.

5. What regions are targeted for future market growth?
   UCB is exploring international markets, including Europe, Asia, and Latin America, contingent on regional approvals.

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References

[1] IQVIA. (2022). Global Epilepsy Market Report.
[2] UCB. (2019). SPRITAM (levetiracetam) approval announcement.
[3] MarketsandMarkets. (2022). Epilepsy Treatment Market Analysis.