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Generated: June 28, 2017
What are the generic sources for carbamazepine and what is the scope of carbamazepine freedom to operate?
Carbamazepine is the generic ingredient in eight branded drugs marketed by Usl Pharma, Taro, Novartis, Validus Pharms Inc, Shire, Torrent Pharms, Wockhardt, Teva, Taro Pharm, Warner Chilcott, Lundbeck Pharms Llc, Inwood Labs, Jubilant Cadista, Apotex Inc, Pliva, Taro Pharm Inds, Teva Pharms, Actavis Elizabeth, and Mylan Ireland Ltd, and is included in twenty-nine NDAs. There are six patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 8 |
| Patents: | 6 |
| Applicants: | 19 |
| NDAs: | 29 |
| Drug Master File Entries: see list | 27 |
| Suppliers / Packagers: see list | 42 |
| Bulk Api Vendors: see list | 99 |
| Clinical Trials: see list | 132 |
| Patent Applications: see list | 5,593 |
| Therapeutic Class: | Bipolar Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | carbamazepine at DailyMed |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 100MG | CAPSULE, EXTENDED RELEASE; ORAL |
| ► Subscribe | ► Subscribe | 300MG | CAPSULE, EXTENDED RELEASE; ORAL |
| ► Subscribe | ► Subscribe | 200MG | CAPSULE, EXTENDED RELEASE; ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apotex Inc | CARBAMAZEPINE | carbamazepine | TABLET;ORAL | 075948-001 | Feb 27, 2002 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Lundbeck Pharms Llc | CARNEXIV | carbamazepine | SOLUTION;IV (INFUSION) | 206030-001 | Oct 7, 2016 | RX | Yes | Yes | 8,410,077 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Apotex Inc | CARBAMAZEPINE | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 078986-001 | Nov 25, 2011 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Lundbeck Pharms Llc | CARNEXIV | carbamazepine | SOLUTION;IV (INFUSION) | 206030-001 | Oct 7, 2016 | RX | Yes | Yes | 9,629,797 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Torrent Pharms | CARBAMAZEPINE | carbamazepine | TABLET;ORAL | 077272-003 | Dec 7, 2005 | RX | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | TEGRETOL | carbamazepine | SUSPENSION;ORAL | 018927-001 | Dec 18, 1987 | 4,409,212 | ► Subscribe | ||||||||||||||||||||||
Novartis | TEGRETOL-XR | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 020234-001 | Mar 25, 1996 | 5,284,662 | ► Subscribe | ||||||||||||||||||||||
Validus Pharms Inc | EQUETRO | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 021710-002 | Dec 10, 2004 | 5,326,570 | ► Subscribe | ||||||||||||||||||||||
Shire | CARBATROL | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 020712-001 | Sep 30, 1997 | 5,912,013 | ► Subscribe | ||||||||||||||||||||||
Validus Pharms Inc | EQUETRO | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 021710-003 | Dec 10, 2004 | 5,326,570 | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,200,088 | Sulfoalkyl ether cyclodextrin compositions | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| European Patent Office | 1928464 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 101314803 | ► Subscribe | |||||||||||||||||||||||||||
| Russian Federation | 2455996 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2009510123 | ► Subscribe | |||||||||||||||||||||||||||
| Mexico | 2010004900 | ► 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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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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