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-eight 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:	4,578
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
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-001	Jul 31, 2015		RX	Yes	No			Y

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
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	207958-002	Jul 31, 2015
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-001	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
Sun Pharmaceutical Industries Europe B.V.	Levetiracetam Sun	levetiracetam	EMEA/H/C/002051Levetiracetam Sun 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 Sun is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults and children from four 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 Sun concentrate is an alternative for patients when oral administration is temporarily not feasible.	Authorised	yes	no	no	2011-12-14

International Patents for SPRITAM

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

Country	Patent Number	Title	Estimated Expiration
Australia	2014228990
Australia	2017202752
Canada	2906029
China	105188849
China	109908355	包含左乙拉西坦的快速分散剂型 (Rapid disperse dosage form containing levetiracetam)
European Patent Office	2968994	FORME PHARMACEUTIQUE À DISPERSION RAPIDE CONTENANT DU LÉVÉTIRACÉTAM (RAPID DISPERSE DOSAGE FORM CONTAINING LEVETIRACETAM)
European Patent Office	3431141	PROCÉDÉ D'IMPRESSION TRIDIMENSIONNELLE (THREE-DIMENSIONAL PRINTING METHOD)

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

SPIRITAM (levetiracetam) market dynamics and financial trajectory: pricing, volume, exclusivity, competitive entry, and revenue drivers

Last updated: July 22, 2026

Executive summary: SPIRITAM is a brand of levetiracetam using Spritam’s 3D printing oral dose technology. The product’s near-term revenue trajectory is determined by (1) ongoing generic substitution for levetiracetam immediate-release (IR) tablets/capsules and (2) the extent to which SPIRITAM’s differentiators (ODT-like convenience via 3D printed tablets and pediatric/feeding convenience) sustain price premia and share versus lower-cost generics. Commercial outcomes are also shaped by payer contracting, channel inventory cycles, and the pace of penetration of generic levetiracetam formulations that match key patient use-cases.

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What is SPIRITAM (levetiracetam) and how does it make money in the market?

SPIRITAM is a levetiracetam product positioned for epilepsy treatment, generally aligned with immediate-release dosing and typical use patterns of levetiracetam therapy in partial-onset seizures and related indications (per FDA-approved labeling). The brand’s revenue engine relies on (a) persistence of share in segments where the 3D printed tablet’s administration advantages matter and (b) payer willingness to reimburse a branded alternative in those niches.

Commercial “value proposition” that affects unit economics

• Patient adherence and administration: 3D printed tablets can be useful for patients who have difficulty swallowing, including some pediatric and institutional patients.
• Prescribing habit and formulary access: Even when alternatives exist, the brand’s retention depends on whether payers keep it on preferred tiers.

Revenue drivers

• Net price discipline versus payer reimbursement: branded products face downward price pressure as formularies expand generic coverage.
• Volume retention amid generic substitution: the brand’s volume decline rate usually tracks how broadly formularies accept generic levetiracetam products in equivalent dosing ranges.
• Mix shift: use across titration schedules and dose strengths can change realized revenue.

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How do generic levetiracetam launches change SPIRITAM market share and pricing?

Levetiracetam is among the most widely genericized antiepileptics globally and in the US. Generic substitution is structurally favorable because levetiracetam has long-standing patent estate depletion and multiple approved generic competitors by strength/dose form.

Market mechanism

• Payers reduce SPIRITAM to less preferred tiers unless SPIRITAM is needed for administration-specific patient segments.
• Pharmacy benefit managers push lower-cost alternatives when therapeutic interchange is supported by contracting.
• Clinicians may still select SPIRITAM for dysphagia or administration convenience, but this tends to be narrower than the overall levetiracetam patient base.

What to expect in financial trajectory

• Revenue is typically “volume-challenged”: unit declines tend to exceed net price declines over time if generic competition is wide.
• Gross-to-net compression rises as rebates and payer terms increase to preserve formulary placement.
• Inventory and rebate timing can create quarter-to-quarter volatility, but the structural drift is usually downward once generic coverage becomes entrenched.

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When does SPIRITAM lose exclusivity, and what does that mean for the revenue curve?

SPIRITAM’s exclusivity is driven by its branded drug product IP and any remaining periods tied to its approved application and manufacturing/dosage-form differentiation. In practice, branded levetiracetam markets move from exclusivity-led growth or stability to a decline pattern once key periods end and generic competition broadens.

Commercial implications of exclusivity decay

• The brand’s revenue usually transitions from share capture (or stability) to erosion.
• Margin compresses from increased promotional intensity and payer concessions.
• New competitors do not need to outperform clinically; they need to clear coverage and switching barriers.

Key outcome for financial trajectory

• The revenue curve tends to flatten briefly after major generic entrants if SPIRITAM retains a segment, then step down as additional dosage strengths or “equivalent administration” alternatives enter.

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What patents protect SPIRITAM, and which IP categories most affect generic risk?

SPIRITAM is tied to levetiracetam and to a specific dosage form approach using 3D printing. The patent estate (as typically structured for branded product-dosage differentiation) affects generic risk through:

1. Dosage form composition and structure (excipients, matrix, porosity, disintegration profile).
2. 3D printing process parameters (manufacturing method claims defining how the tablet is built).
3. Form-factor and performance claims (dissolution/disintegration criteria for rapid wetting or dispersion).
4. Method-of-use claims (if any are present, which is less common for established molecules).

How this translates into market outcomes

• If generic entrants use different manufacturing approaches, they may still be able to launch if they avoid infringing specific composition/process claims or if the claims are invalidated or do not cover their product.
• If the key differentiating IP is strong and enforced, generic entry can slow or be limited to certain strengths/dose forms.

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What is the Orange Book status of SPIRITAM, and how does it map to launch risk?

SPIRITAM’s Orange Book listing(s) determine which generic pathways must address listed patents through paragraph IV certifications or other grounds.

How Orange Book status affects financial trajectory

• If Orange Book listings include active, enforceable patents, generics face litigation and potential launch delay.
• If listings are narrow or expire early, generic competitors can launch sooner, accelerating revenue erosion.
• If multiple patents remain but are weak or not asserted, the market impact still tends to be rapid once at least one challenge succeeds or an at-risk launch is permitted.

(No Orange Book patent list is provided in the prompt; the analysis above reflects the standard linkage between Orange Book listings and generic launch timelines.)

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What patent litigation and Paragraph IV challenges affect SPIRITAM generics?

For branded small molecules with dosage-form differentiation, litigation outcomes influence whether generics face:

• Design-around constraints (delayed entry).
• Settlement-triggered entry dates.
• At-risk launches if exclusivity is disputed or patents are found not infringed/invalid.

Market impact channels

• Settlement agreements: can impose delayed entry windows even after generics file.
• Court outcomes: can accelerate entry or limit the number of strengths a generic can commercialize.
• Injunctions or consent judgments: can create temporary availability gaps that sustain brand revenue.

(No specific case captions, docket dates, or settlement terms are included in the prompt; the litigation framework above links expected drivers to typical branded levetiracetam commercialization patterns.)

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How strong is the patent estate for SPIRITAM compared with generic levetiracetam substitutes?

A practical “strength” assessment for investor and licensing use focuses on:

• Remaining life of key patents
• Breadth of composition/process claims
• Whether courts have already constrained similar IP for other 3D printed tablet technologies
• Whether generic manufacturers can design around with alternative excipient systems or printing profiles

Market consequence

• If patents remain active and broad, generics may enter with delays or limited coverage.
• If patents are expiring or easy to design around, the brand experiences faster share loss.

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How does SPIRITAM compare with other levetiracetam formulations and delivery systems?

The core comparison set for SPIRITAM includes:

• Immediate-release generic levetiracetam tablets/capsules (lowest cost, widest payer coverage)
• Other branded levetiracetam products (if any within the same class and dosing form)
• Alternative administration formats (where available) designed to address swallowing difficulty

Competitive advantage that matters commercially

• SPIRITAM’s differentiator is administration and disintegration behavior tied to the 3D printed platform. This tends to be most compelling when:
  • the patient has difficulty swallowing tablets,
  • pediatric dosing needs fine adjustment,
  • institutions require simplified administration logistics.

Net effect

• Even with clinical practicality, payer coverage tends to dominate overall volume unless the product is a defined formulary exception product for dysphagia or specific institutional protocols.

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Which companies are challenging SPIRITAM, and what does that imply for share erosion?

Generic levetiracetam competition usually includes multiple large generic manufacturers and specialty generic platforms with strong ANDA throughput. The implication is:

• With multiple filers, the earliest successful or settlement-backed entrant often sets the pricing floor.
• Subsequent entrants intensify discounts, increasing net revenue erosion.

(No competitor names are supplied in the prompt; therefore, no company-specific challenge mapping is provided.)

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What generic entry risks exist for SPIRITAM by dose strength and timeline?

Dose-strength granularity affects rollout speed. A common financial pattern:

• First generic entry attacks high-volume strengths.
• Subsequent entries fill remaining strengths, tightening the net price floor across the dosing ladder.

Entry risk factors

• Patent landscape by strength-specific listings (if any)
• Design-around feasibility for the 3D printing approach
• Manufacturing scale capability for higher-volume strengths

Expected financial shape

• Steep drop upon first wave entry, then gradual erosion as more strengths are covered and payer contracts tighten.

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How do payer formularies, rebates, and net-to-gross drive SPIRITAM financial trajectory?

In branded antiepileptics, realized revenue is heavily influenced by:

• Contracted net pricing (payer-specific)
• Pharmacy reimbursement settings (MAC list behavior)
• Volume-based rebates and access payments
• Institutional group purchasing for hospital and nursing settings

Typical outcome under generic competition

• Gross-to-net rises as the brand competes for formulary placement.
• Net revenue declines can outpace wholesale unit declines if rebates increase faster than list price decreases.
• The product may maintain relatively stable gross list pricing while net pricing falls materially.

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What is the outlook for SPIRITAM revenue growth versus erosion?

SPIRITAM’s trajectory should be modeled as a base-case of ongoing revenue erosion with potential stabilization only in segments where administration convenience drives continued prescribing.

Scenario framework (directional)

• Bear case: broad formulary substitution, faster generic penetration, higher rebate burden.
• Base case: continued share loss but slower than the overall class due to administration-specific retention.
• Bull case: limited generic equivalence for the targeted patient use-case or strong institutional adoption that sustains payer exceptions.

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Key financial metrics to track for SPIRITAM (what will move the number)?

For investment and licensing decisions, the metrics that tend to correlate with the financial trajectory include:

• Net sales by dose strength (erosion is often strength-specific)
• Gross-to-net trend (rebate pressure proxy)
• Script volumes and TRx trends (unit-level visibility into share)
• Average net selling price (ANSP) versus list price changes
• Trade inventory indicators (channel overhang or destocking)
• Formulary position changes by major PBMs and large health systems

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Key Takeaways

• SPIRITAM’s market dynamics are dominated by generic levetiracetam substitution and payer contracting, with 3D printing administration convenience as the main retention lever.
• Financial trajectory is expected to shift from exclusivity-led stability to structurally declining revenue as coverage expands and more strengths face generic competition.
• The patent and Orange Book landscape determines whether generics face delays, but once coverage is achieved, net revenue compression and share erosion usually accelerate.
• The most important “numbers to watch” are net sales by strength, gross-to-net, and TRx/script trends, as these capture payer and switching effects faster than list price metrics.

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FAQs

1. Why do some patients remain on SPIRITAM instead of generic levetiracetam?
   Administration convenience for dysphagia and certain pediatric or institutional workflows can sustain niche prescribing even when generics are broadly covered.

2. Does SPIRITAM pricing remain stable even when generic competition increases?
   List pricing can remain stable, but realized net pricing typically falls through rebates and payer contract changes, driving gross-to-net deterioration.

3. How do dosage strength-specific generic entries affect SPIRITAM net sales?
   First-wave generics often target high-volume strengths, causing the steepest revenue impact, followed by additional strength launches that tighten the net price floor.

4. What matters more for SPIRITAM revenue: patent enforcement or payer coverage?
   Patent enforcement can delay entry, but payer coverage typically determines the speed and magnitude of share loss once generics are launched and reimbursed.

5. What operational factors influence whether SPIRITAM maintains share?
   Institutional formulary adoption, availability in key strength SKUs, pharmacy substitution behavior, and administration logistics drive whether the product stays on preferred tiers for relevant patient subsets.

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References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Drug details for SPIRITAM, including listed patents and exclusivity information). US Food and Drug Administration.
2. FDA Drug Approval Package for SPIRITAM (levetiracetam) and labeling history. US Food and Drug Administration.

DrugChatter Q&A for SPRITAM

Do all the strenghts of spritam hava generic?