LEVETIRACETAM - Generic Drug Details

What are the generic sources for levetiracetam and what is the scope of freedom to operate?

Levetiracetam is the generic ingredient in six branded drugs marketed by Ucb Inc, Am Regent, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly Pharm, Hikma Farmaceutica, Hospira Inc, Jubilant Generics, Knack, Micro Labs, MSN, Mylan Labs Ltd, Prinston Inc, Sagent Pharms, Sun Pharm Inds Ltd, Xgen Pharms, B Braun Medical, Baxter Hlthcare Corp, Caplin, Gland, Hikma, Hq Spclt Pharma, Nexus, Actavis Mid Atlantic, Ajenat Pharms, Alembic, Amneal Pharms, Anda Repository, Apotex Inc, Aurobindo Pharma, Bionpharma, Chartwell Molecular, Hetero Labs Ltd Iii, Lupin Ltd, Pharm Assoc, Pharmobedient Cnsltg, Quagen, Strides Pharma, Taro, Tolmar, Tripoint, Actavis Elizabeth, Actavis Labs Fl Inc, Adaptis, Aiping Pharm Inc, Apotex, Aurobindo Pharma Usa, Chartwell Rx, Hisun Pharm Hangzhou, Lotus Pharm Co Ltd, Overseas, Ph Health, Pharmadax, Rouses Point Pharms, Sandoz, Sciegen Pharms, Sun Pharm, Sun Pharm Industries, Teva Pharms, Torrent Pharms Ltd, Aprecia Pharms, Accord Hlthcare, Alkem Labs Ltd, China Resources, Fosun Pharma, Granules, Ingenus Pharms Llc, Invagen Pharms, Lupin, Mpp Pharma, Mylan, Orbion Pharms, Oxford Pharms, Rising, Senores Pharms, Torrent Pharms, Viwit Pharm, Watson Labs Inc, Zhejiang Jingxin, and Zydus Pharms Usa Inc, and is included in one hundred and eleven NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Levetiracetam has ninety-two patent family members in thirty countries.

There are thirty-five drug master file entries for levetiracetam. Eighty-seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for LEVETIRACETAM

International Patents:	92
US Patents:	10
Tradenames:	6
Applicants:	81
NDAs:	111
Drug Master File Entries:	35
Finished Product Suppliers / Packagers:	87
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	249
Patent Applications:	7,146
Drug Prices:	Drug price trends for LEVETIRACETAM
Drug Sales Revenues:	Drug sales revenues for LEVETIRACETAM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEVETIRACETAM
What excipients (inactive ingredients) are in LEVETIRACETAM?	LEVETIRACETAM excipients list
DailyMed Link:	LEVETIRACETAM at DailyMed

See drug prices for LEVETIRACETAM

See drug sales revenues for LEVETIRACETAM

Recent Clinical Trials for LEVETIRACETAM

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

Sponsor	Phase
Hospices Civils de Lyon	PHASE3
Nebraska Methodist Health System	PHASE3
Mansoura University	PHASE4

See all LEVETIRACETAM clinical trials

Generic filers with tentative approvals for LEVETIRACETAM

Applicant	Application No.	Strength	Dosage Form
		500MG	TABLET;ORAL
		1GM	TABLET;ORAL
		750MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for LEVETIRACETAM

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Anatomical Therapeutic Chemical (ATC) Classes for LEVETIRACETAM

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for LEVETIRACETAM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KEPPRA XR	Extended-release Tablets	levetiracetam	1000 mg	022285	2	2011-01-07
KEPPRA	Tablets	levetiracetam	1000 mg	021035	1	2007-01-24

US Patents and Regulatory Information for LEVETIRACETAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msn	LEVETIRACETAM	levetiracetam	INJECTABLE;INTRAVENOUS	215980-001	Nov 15, 2022	AP	RX	No	No
Lotus Pharm Co Ltd	LEVETIRACETAM	levetiracetam	TABLET;ORAL	090906-002	Oct 31, 2016		DISCN	No	No
Fresenius Kabi Usa	LEVETIRACETAM	levetiracetam	INJECTABLE;INTRAVENOUS	090813-001	May 26, 2010		DISCN	No	No

Expired US Patents for LEVETIRACETAM

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	9,463,160
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-004	Jul 31, 2015	9,463,160
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-003	Nov 30, 1999	4,837,223

EU/EMA Drug Approvals for LEVETIRACETAM

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

International Patents for LEVETIRACETAM

Country	Patent Number	Title	Estimated Expiration
China	109908355	包含左乙拉西坦的快速分散剂型 (Rapid disperse dosage form containing levetiracetam)
Canada	2906029
Spain	2403069

Supplementary Protection Certificates for LEVETIRACETAM

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 Levetiracetam

Last updated: March 5, 2026

What Is the Current Market Size and Growth Outlook for Levetiracetam?

Levetiracetam — marketed primarily as Keppra — is a broad-spectrum antiepileptic drug approved since 1999. The global market for levetiracetam was valued at approximately USD 2.3 billion in 2022. The compound's annual growth rate (CAGR) is projected at 4.9% from 2023 to 2030, driven by increasing epilepsy prevalence and expanding indications.

Year	Market Size (USD billion)	CAGR (%)
2022	2.3	—
2023	2.4	4.9
2025	2.8	4.9
2030	3.7	—

Growth drivers include rising diagnosis rates, broader age group treatment, and off-label use for neuropathic pain.

Who Are the Major Market Competitors?

Levetiracetam faces competition from other antiepileptic drugs (AEDs) such as:

• Carbamazepine
• Valproate
• Lamotrigine

However, levetiracetam’s favorable side effect profile and minimal drug-drug interactions give it an edge. It has generic versions, which dominate the price-sensitive segments.

Top manufacturers include UCB Pharma (original patent holder), Teva, Sandoz, and Mylan. UCB's branded product accounts for over 60% of sales in North America.

How Are Regulatory Policies Influencing Market Dynamics?

Patent expirations created opportunities for generics post-2018. Regulatory agencies, notably the FDA and EMA, approve generics with bioequivalence. This influx increased the market share of generics, reducing the average price per treatment course by 25% between 2018 and 2022.

National reimbursement policies favor generics, further shrinking revenue for brand-name levetiracetam. Countries like the United States see ban on off-patent drug pricing, pressuring margins.

Recent developments include:

• FDA approval for extended-release versions (2020)
• EMA guidance supporting biosimilar approval (2021)

What Are the Key Trends Impacting the Financial Trajectory?

1. Generic Competition: Imminent patent cliffs for branded formulations led to aggressive entry by generics, driving volume but reducing profit margins.
2. Off-Label Indications: Use for neuropathic pain and bipolar disorder expands market size but lacks formal approval, risking regulatory scrutiny.
3. Market Expansion in Emerging Economies: Increased healthcare access in Asia-Pacific and Latin America raises demand. Market penetration rate in these regions is currently below 35% but expected to reach 55% by 2030.
4. Formulation Innovations: Development of extended-release and injectable formulations aims to capture niche markets and improve administration adherence.

What Are the Financial Risks and Opportunities?

Risks:

• Price erosion due to generic competition.
• Regulatory shifts toward restrictive prescribing.
• Off-label use without approval raises liability concerns.

Opportunities:

• Development of new formulations or delivery systems.
• Expansion into additional indications with clinical trials.
• Strategic partnerships in emerging markets.

What Are the Long-Term Revenue Projections?

Assuming ongoing generic competition and stable demand, the revenue for branded levetiracetam is projected to decline by 3-5% annually post-2025. Meanwhile, total market revenue—including generics—may grow to USD 4 billion by 2030.

Investment in R&D for new formulations and expanded indications could offset revenue declines. Companies maintaining patent rights or developing unique formulations stand to sustain higher margins.

Key Takeaways

• Market size estimated at USD 2.3 billion in 2022, growing to USD 3.7 billion in 2030.
• Generic drugs dominate, compressing profit margins for brand-name producers.
• Regulatory environment favors biosimilars, impacting revenue streams.
• Emerging markets present growth opportunities; developed markets face intense price competition.
• Innovation in formulations and indications offers pathways for revenue preservation.

FAQs

Q1: How does patent expiration affect levetiracetam sales?

A1: Patent expiration typically leads to generic entry, causing price reductions and volume increases, but reduces profits for brand holders.

Q2: What are the primary factors driving growth in emerging markets?

A2: Increasing epilepsy diagnosis, expanding healthcare infrastructure, and rising affordability improve access to levetiracetam.

Q3: How do regulatory policies influence drug pricing?

A3: Agencies promote generic substitution and implement pricing controls, exerting downward pressure on prices.

Q4: Are there opportunities for new drugs based on levetiracetam?

A4: Yes, developing extended-release formulations and new indications can create revenue growth beyond existing patents.

Q5: What risk does off-label use pose for levetiracetam manufacturers?

A5: Off-label expansion can lead to regulatory scrutiny and liability issues if unapproved uses face adverse outcomes.

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References

[1] MarketsandMarkets. (2022). Anti-epileptic Drugs Market by Type, Route of Administration, and Region.
[2] Evaluate Pharma. (2023). Epilepsy Drug Market Data.
[3] U.S. Food and Drug Administration. (2021). Guidance for Biosimilar Approval.
[4] European Medicines Agency. (2021). Biosimilar Medicines: Overview.