FELBATOL Drug Patent Profile
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Which patents cover Felbatol, and when can generic versions of Felbatol launch?
Felbatol is a drug marketed by Mylan Speciality Lp and is included in one NDA.
The generic ingredient in FELBATOL is felbamate. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the felbamate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Felbatol
A generic version of FELBATOL was approved as felbamate by AMNEAL PHARMS on September 13th, 2011.
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Questions you can ask:
- What is the 5 year forecast for FELBATOL?
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Summary for FELBATOL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 115 |
| Clinical Trials: | 1 |
| Patent Applications: | 4,151 |
| Drug Prices: | Drug price information for FELBATOL |
| What excipients (inactive ingredients) are in FELBATOL? | FELBATOL excipients list |
| DailyMed Link: | FELBATOL at DailyMed |
Recent Clinical Trials for FELBATOL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute of Mental Health (NIMH) | Phase 2 |
Pharmacology for FELBATOL
| Drug Class | Anti-epileptic Agent |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
US Patents and Regulatory Information for FELBATOL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | FELBATOL | felbamate | SUSPENSION;ORAL | 020189-003 | Jul 29, 1993 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan Speciality Lp | FELBATOL | felbamate | TABLET;ORAL | 020189-001 | Jul 29, 1993 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan Speciality Lp | FELBATOL | felbamate | TABLET;ORAL | 020189-002 | Jul 29, 1993 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 FELBATOL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | FELBATOL | felbamate | SUSPENSION;ORAL | 020189-003 | Jul 29, 1993 | ⤷ Sign Up | ⤷ Sign Up |
| Mylan Speciality Lp | FELBATOL | felbamate | TABLET;ORAL | 020189-001 | Jul 29, 1993 | ⤷ Sign Up | ⤷ Sign Up |
| Mylan Speciality Lp | FELBATOL | felbamate | TABLET;ORAL | 020189-002 | Jul 29, 1993 | ⤷ Sign Up | ⤷ Sign Up |
| Mylan Speciality Lp | FELBATOL | felbamate | TABLET;ORAL | 020189-002 | Jul 29, 1993 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FELBATOL
See the table below for patents covering FELBATOL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 142492 | ⤷ Sign Up | |
| Spain | 2094145 | ⤷ Sign Up | |
| Greece | 3021801 | ⤷ Sign Up | |
| European Patent Office | 0491094 | Felbamate pour le traitement du syndrom de Lennox-Gastaut (Felbamate for treating Lennox-Gastaut syndrome) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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 verification 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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