EXSERVAN Drug Patent Profile
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Which patents cover Exservan, and what generic alternatives are available?
Exservan is a drug marketed by Aquestive and is included in one NDA. There are two patents protecting this drug.
This drug has one hundred and sixty-two patent family members in nineteen countries.
The generic ingredient in EXSERVAN is riluzole. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the riluzole profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Exservan
A generic version of EXSERVAN was approved as riluzole by IMPAX LABS on January 29th, 2003.
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Summary for EXSERVAN
| International Patents: | 162 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 166 |
| Patent Applications: | 5,278 |
| Drug Prices: | Drug price information for EXSERVAN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EXSERVAN |
| What excipients (inactive ingredients) are in EXSERVAN? | EXSERVAN excipients list |
| DailyMed Link: | EXSERVAN at DailyMed |
US Patents and Regulatory Information for EXSERVAN
EXSERVAN is protected by two US patents.
Patents protecting EXSERVAN
Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
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Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aquestive | EXSERVAN | riluzole | FILM;ORAL | 212640-001 | Nov 22, 2019 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Aquestive | EXSERVAN | riluzole | FILM;ORAL | 212640-001 | Nov 22, 2019 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 EXSERVAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Aquestive | EXSERVAN | riluzole | FILM;ORAL | 212640-001 | Nov 22, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| Aquestive | EXSERVAN | riluzole | FILM;ORAL | 212640-001 | Nov 22, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for EXSERVAN
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Sanofi Mature IP | Rilutek | riluzole | EMEA/H/C/000109 Rilutek is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).Clinical trials have demonstrated that Rilutek extends survival for patients with ALS.Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.There is no evidence that Rilutek exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms.Rilutek has not been shown to be effective in the late stages of ALS.Safety and efficacy of Rilutek has only been studied in ALS. Therefore, Rilutek should not be used in patients with any other form of motor-neurone disease. |
Authorised | no | no | no | 1996-06-10 | |
| Zentiva k.s. | Riluzole Zentiva | riluzole | EMEA/H/C/002622 Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).Clinical trials have demonstrated that Riluzole Zentiva extends survival for patients with ALS. Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.There is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. Riluzole Zentiva has not been shown to be effective in the late stages of ALS.Safety and efficacy of Riluzole Zentiva has only been studied in ALS. Therefore, Riluzole Zentiva should not be used in patients with any other form of motor-neurone disease. |
Authorised | no | no | no | 2012-05-07 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for EXSERVAN
See the table below for patents covering EXSERVAN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2005510756 | ⤷ Sign Up | |
| Japan | 5144776 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2004066986 | ⤷ Sign Up | |
| Denmark | 1587504 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 03030882 | ⤷ 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.
ISSN: 2162-2639
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