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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 |
Recent Clinical Trials for levetiracetam
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Cambridge | Phase 3 |
Cambridge University Hospitals NHS Foundation Trust | Phase 3 |
Royal Brisbane and Women's Hospital | Phase 2 |
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
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
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
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
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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