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:	1
Raw Ingredient (Bulk) Api Vendors:	132
Patent Applications:	3,497
Drug Prices:	Drug price information 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		RX	Yes	Yes			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	No			Y
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-003	Jul 31, 2015		RX	Yes	No			Y
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-003	Jul 31, 2015		RX	Yes	No			Y
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-004	Jul 31, 2015		RX	Yes	Yes
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	207958-002	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
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/000277 Keppra 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/002783 Levetiracetam 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/002290 Levetiracetam 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/002024 Matever 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/002355 Levetiracetam 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/002305 Levetiracetam 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/002051 Levetiracetam 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
European Patent Office	3431141	PROCÉDÉ D'IMPRESSION TRIDIMENSIONNELLE (THREE-DIMENSIONAL PRINTING METHOD)
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)
Japan	2001512488
Mexico	2015012134	FORMA DE DOSIFICACION DE DISPERSION RAPIDA QUE CONTIENE LEVETIRACETAM. (RAPID DISPERSE DOSAGE FORM CONTAINING LEVETIRACETAM.)
World Intellectual Property Organization (WIPO)	9836738
Hong Kong	1214787	包含左乙拉西坦的快速分散劑型 (RAPID DISPERSE DOSAGE FORM CONTAINING LEVETIRACETAM)
Australia	6331498

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

SPRITAM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SPRITAM

Introduction to SPRITAM

SPRITAM, developed by Aprecia Pharmaceuticals, is a groundbreaking drug that marked a significant milestone in the pharmaceutical industry as the first 3D printed medicine approved by the U.S. Food and Drug Administration (FDA) in August 2015. It is an adjunctive therapy for the treatment of seizures in patients with epilepsy, utilizing Aprecia's proprietary ZipDose technology platform[3][4].

Market Drivers

The growth of the 3D printed drugs market, including SPRITAM, is driven by several key factors:

Demand for Instantaneous Soluble Drugs

The surge in demand for instantaneous soluble drugs that can disperse easily in the mouth is a major driver. Patients, especially those with dysphagia, benefit significantly from these fast-melting formulations[1][4].

Increase in Prevalence of Dysphagia

The rising prevalence of dysphagia, a condition that makes swallowing difficult, has increased the need for drugs like SPRITAM that are easy to administer[4].

Adoption of 3D Printing in Healthcare

The increasing adoption of 3D printing techniques in the medical and healthcare industries has opened up new avenues for drug manufacturing. This technology allows for the production of complex drug formulations that were previously challenging to manufacture[4].

Personalized Medicine

The trend towards personalized medicine also boosts the market for 3D printed drugs. These drugs can be tailored to individual patient needs, enhancing efficacy and patient compliance[4].

Financial Trajectory

Initial Funding and Financing

Aprecia Pharmaceuticals secured significant funding to advance the development and commercialization of SPRITAM. In 2016, the company completed a $35 million preferred stock financing led by Deerfield Management Company, which converted all outstanding convertible debt into preferred stock. This financing was crucial for the commercialization of SPRITAM and the development of additional 3D printed drug formulations[2].

Additional Financing

In addition to the initial funding, Aprecia secured up to $30 million from Hercules Capital in a debt financing agreement. This funding was used to purchase additional manufacturing equipment, fund the development of pipeline products, and advance the ZipDose technology platform[5].

Market Performance and Projections

Current Market Status

SPRITAM, launched in March 2016, is the only 3D printed drug currently available in the market. It has been successful in treating epilepsy, with clinical trials demonstrating significant reductions in seizure frequency[3].

Market Projections

The global 3D printed drugs market, led by SPRITAM, is projected to reach $522 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 6.5% from 2020 to 2030. The potential market for other 3D printed drugs is estimated to have been $278 million in 2020, indicating a moderate growth scenario[1][4].

Geographical Market Analysis

U.S. Market

The U.S. market holds the highest market share for 3D printed drugs, driven by the initial launch and commercialization of SPRITAM in the United States. The country's advanced healthcare infrastructure and regulatory environment have been conducive to the growth of this market segment[1].

Europe and Asia-Pacific

Europe accounts for a significant share of the market due to high demand for technologically innovative products and the presence of better healthcare centers. However, the Asia-Pacific region possesses high growth potential due to increasing awareness about 3D printed drugs, government initiatives for healthcare improvement, and rising disposable incomes[4].

Clinical Trials and Efficacy

FDA Approval

SPRITAM's FDA approval was based on three multi-center, double-blind, randomized, placebo-controlled clinical studies. These studies demonstrated statistically significant reductions in seizure frequency, with a significant percentage of patients achieving more than 50% reduction in weekly seizure rates compared to the placebo group[3].

Clinical Outcomes

The clinical trials highlighted the efficacy of SPRITAM in treating various types of seizures associated with epilepsy. The drug's fast-melting formulation, enabled by ZipDose technology, has improved patient compliance and outcomes[3].

Conclusion

SPRITAM has paved the way for the 3D printed drugs market, driven by its innovative technology, clinical efficacy, and growing demand for easy-to-administer medications. With significant financial backing and a strong market trajectory, Aprecia Pharmaceuticals is well-positioned to continue advancing in the pharmaceutical industry.

Key Takeaways

• First 3D Printed Drug: SPRITAM is the first and only 3D printed drug approved by the FDA.
• Market Growth: The global 3D printed drugs market is projected to reach $522 million by 2030, growing at a CAGR of 6.5%.
• Demand Drivers: Surge in demand for instantaneous soluble drugs, increase in dysphagia prevalence, and adoption of 3D printing in healthcare drive market growth.
• Financial Support: Significant funding from investors like Deerfield Management and Hercules Capital has supported the development and commercialization of SPRITAM.
• Clinical Efficacy: SPRITAM has demonstrated significant reductions in seizure frequency in clinical trials.

FAQs

Q: What is SPRITAM and how is it different from other drugs? A: SPRITAM is the first 3D printed drug approved by the FDA, using Aprecia's proprietary ZipDose technology to create a fast-melting formulation for treating epilepsy.

Q: What are the key drivers of the 3D printed drugs market? A: The key drivers include the demand for instantaneous soluble drugs, increase in dysphagia prevalence, adoption of 3D printing in healthcare, and the trend towards personalized medicine.

Q: How much funding has Aprecia Pharmaceuticals received for SPRITAM? A: Aprecia received $35 million in preferred stock financing and up to $30 million in debt financing to support the development and commercialization of SPRITAM.

Q: What are the projected market figures for 3D printed drugs by 2030? A: The global 3D printed drugs market is projected to reach $522 million by 2030, growing at a CAGR of 6.5%.

Q: Where does the U.S. stand in the market for 3D printed drugs? A: The U.S. holds the highest market share for 3D printed drugs, driven by the initial launch and commercialization of SPRITAM.

Sources

1. EIN Presswire: "3D Printed Drugs Market Sets New Record, Projected at USD 522 million by 2030 | CAGR of 6.5%."
2. PR Newswire: "Aprecia Pharmaceuticals Set to Advance 3D Printed Drug Pipeline with Completion of $35 Million Financing Led by Deerfield Management."
3. Clinical Trials Arena: "Spritam (levetiracetam) for the Treatment of Epilepsy."
4. Allied Market Research: "3D Printed Drugs Market by Spritam and Other Drugs Potential | 2030."
5. PR Newswire: "Aprecia Pharmaceuticals Secures up to $30 Million from Hercules Capital."