Levetiracetam - Generic Drug Details

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What are the generic drug 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, Akorn, Am Regent, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hainan Poly Pharm, Hikma Farmaceutica, Hospira Inc, Jubilant Generics, Micro Labs, Mylan Labs Ltd, Sagent Pharms, Sun Pharm Inds Ltd, Xgen Pharms, Gland Pharma Ltd, Hq Speciality Pharma, Nexus Pharms, Aci Healthcare Ltd, Actavis Mid Atlantic, Alembic Labs, Amneal Pharms, Anda Repository, Apotex Inc, Breckenridge, Hetero Labs Ltd Iii, Hi-tech Pharmacal, Lannett Co Inc, Lupin Ltd, Pharm Assoc, Taro, Tris Pharma Inc, Wockhardt Bio Ag, Sparc, Actavis Elizabeth, Actavis Labs Fl Inc, Anchen Pharms, Apotex, Florida, Hisun Pharm Hangzhou, Lotus Pharm Co Ltd, Mylan Pharms Inc, Overseas, Pharma Life, Pharmadax Inc, Prinston Inc, Rouses Point Pharms, Sandoz, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva Pharms, Torrent Pharms Ltd, Virtus Pharms, Aprecia Pharms, Accord Hlthcare, Aurobindo Pharma, Breckenridge Pharm, Chartwell Rx, Dr Reddys Labs Ltd, Fosun Pharma, Invagen Pharms, Lupin, Mylan, Orchid Hlthcare, Oxford Pharms, Secan Pharms, Torrent Pharms, Viwit Pharm, Vkt Pharma, Watson Labs Inc, Wockhardt, Zhejiang Jingxin, and Zydus Pharms Usa Inc, and is included in ninety-six NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

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

Summary for levetiracetam

International Patents:	93
US Patents:	9
Tradenames:	6
Applicants:	73
NDAs:	96
Drug Master File Entries:	35
Suppliers / Packagers:	79
Bulk Api Vendors:	117
Clinical Trials:	196
Patent Applications:	4,356
Formulation / Manufacturing:	see details
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

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Drug Sales Revenue Trends for levetiracetam

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Recent Clinical Trials for levetiracetam

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Sponsor	Phase
University of Cambridge	Phase 3
Cambridge University Hospitals NHS Foundation Trust	Phase 3
Royal Brisbane and Women's Hospital	Phase 2

See all levetiracetam clinical trials

Generic filers with tentative approvals for LEVETIRACETAM

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

Paragraph IV (Patent) Challenges for LEVETIRACETAM

Tradename	Dosage	Ingredient	NDA	Submissiondate
KEPPRA XR	TABLET, EXTENDED RELEASE;ORAL	levetiracetam	022285	2011-01-07
KEPPRA	TABLET;ORAL	levetiracetam	021035	2007-01-24

US Patents and Regulatory Information for levetiracetam

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Accord Hlthcare	LEVETIRACETAM	levetiracetam	TABLET;ORAL	090843-001	Feb 14, 2011	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Pharma Life	LEVETIRACETAM	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	204754-001	Aug 26, 2016	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Zhejiang Jingxin	LEVETIRACETAM	levetiracetam	TABLET;ORAL	091491-002	Dec 14, 2010	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-002	Nov 30, 1999	AB	RX	Yes	No	Start Trial	Start Trial			Y	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for levetiracetam

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-004	Jan 6, 2006	Start Trial	Start Trial
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-003	Jul 31, 2015	Start Trial	Start Trial
Ucb Inc	KEPPRA	levetiracetam	INJECTABLE;INTRAVENOUS	021872-001	Jul 31, 2006	Start Trial	Start Trial
Ucb Inc	KEPPRA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	022285-001	Sep 12, 2008	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for levetiracetam

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007012439	Start Trial
Serbia	53690	Start Trial
African Regional IP Organization (ARIPO)	200603602	Start Trial
Canada	2581831	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for levetiracetam

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

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