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.
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
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 166 |
Patent Applications: | 4,232 |
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
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 | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
>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 | 8,603,514 | ⤷ Try for Free |
Aquestive | EXSERVAN | riluzole | FILM;ORAL | 212640-001 | Nov 22, 2019 | 8,765,167 | ⤷ Try for Free |
>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 |
---|---|---|---|
Australia | 2002348432 | ⤷ Try for Free | |
Brazil | PI0410956 | pelìculas com base em óxido de polietileno e sistemas de liberação de droga feitos delas | ⤷ Try for Free |
Canada | 2456234 | INSTRUMENTS OPTIQUES ACCORDABLES (TUNABLE OPTICAL INSTRUMENTS) | ⤷ Try for Free |
China | 101534803 | A method of administering a film product containing a drug | ⤷ Try for Free |
European Patent Office | 2079457 | PROCÉDÉ DESTINÉ À ADMINISTRER UN PRODUIT EN FILM CONTENANT UN MÉDICAMENT (A METHOD OF ADMINISTERING A FILM PRODUCT CONTAINING A DRUG) | ⤷ Try for Free |
Norway | 20056060 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for Exservan
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