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Generated: July 23, 2017
What are the generic sources for levetiracetam and what is the scope of levetiracetam freedom to operate?
Levetiracetam is the generic ingredient in six branded drugs marketed by Hi-tech Pharmacal, Teva Pharms, Secan Pharms, Dr Reddys Labs Ltd, Ucb Inc, Prinston Inc, Lotus Pharm Co Ltd, Tolmar, Mylan Labs Ltd, Actavis Labs Fl Inc, Intellipharmaceutics, Breckenridge Pharm, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hetero Labs Ltd Iii, Zydus Pharms Usa Inc, Mylan, Vintage Pharms, Rouses Point Pharms, Sandoz, Lupin, Orchid Hlthcare, Sagent Pharms, Wockhardt, Invagen Pharms, Jubilant Life, Torrent Pharms Ltd, Aci Healthcare Ltd, Luitpold, Hq Speciality Pharma, Accord Hlthcare, Sun Pharm Inds Ltd, Eci Pharms Llc, Pharm Assoc, Actavis Elizabeth, Apotex Inc, Aprecia Pharms Co, Torrent Pharms, Sun Pharma Global, Anchen Pharms, Taro, Tris Pharma Inc, Silarx, Pharmadax Inc, Orit Labs Llc, Dexcel Pharma, Methapharm, Hospira Inc, Mylan Pharms Inc, Actavis Mid Atlantic, Hikma Farmaceutica, Allied Pharma Inc, X Gen Pharms, Sun Pharm Inds, Virtus Pharms, Amneal Pharms, Lupin Ltd, Ajanta Pharma, Aurobindo Pharma, and Watson Labs Inc, and is included in eighty-seven NDAs. There are seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 6 |
| Patents: | 7 |
| Applicants: | 60 |
| NDAs: | 87 |
| Drug Master File Entries: see list | 35 |
| Suppliers / Packagers: see list | 96 |
| Bulk Api Vendors: see list | 78 |
| Clinical Trials: see list | 173 |
| Patent Applications: see list | 3,164 |
| Therapeutic Class: | Anticonvulsants |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | levetiracetam at DailyMed |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 250MG | TABLET;ORAL |
| ► Subscribe | ► Subscribe | 500MG | TABLET;ORAL |
| ► Subscribe | ► Subscribe | 1GM | TABLET;ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Torrent Pharms | LEVETIRACETAM | levetiracetam | TABLET;ORAL | 078858-003 | Jan 15, 2009 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Mylan Pharms Inc | LEVETIRACETAM | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 200475-001 | Dec 19, 2011 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Hetero Labs Ltd Iii | LEVETIRACETAM | levetiracetam | TABLET;ORAL | 090515-003 | Oct 8, 2010 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Torrent Pharms | LEVETIRACETAM | levetiracetam | TABLET;ORAL | 078858-004 | Jan 15, 2009 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Prinston Inc | LEVETIRACETAM | levetiracetam | TABLET;ORAL | 078106-003 | Feb 10, 2009 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-001 | Nov 30, 1999 | 4,943,639*PED | ► Subscribe | ||||||||||||||||||||||
Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-002 | Nov 30, 1999 | 4,837,223 | ► Subscribe | ||||||||||||||||||||||
Ucb Inc | KEPPRA | levetiracetam | SOLUTION;ORAL | 021505-001 | Jul 15, 2003 | 4,837,223 | ► Subscribe | ||||||||||||||||||||||
Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-002 | Nov 30, 1999 | 4,943,639*PED | ► Subscribe | ||||||||||||||||||||||
Ucb Inc | KEPPRA XR | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 022285-001 | Sep 12, 2008 | 4,943,639*PED | ► Subscribe | ||||||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,114,072 | Dosage form exhibiting rapid disperse properties, methods of use and process for the manufacture of same | ► Subscribe | |||||||||||||||||||||||||||
| 7,863,316 | Extended release formulation of Levetiracetam | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Norway | 20074316 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2281473 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2016514680 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 184822 | ► Subscribe | |||||||||||||||||||||||||||
| Ukraine | 89216 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 00028 | Netherlands | ► Subscribe | PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929 | ||||||||||||||||||||||||||
| 00C/032 | Belgium | ► Subscribe | PRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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