RILUTEK Drug Patent Profile
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Which patents cover Rilutek, and when can generic versions of Rilutek launch?
Rilutek is a drug marketed by Covis and is included in one NDA.
The generic ingredient in RILUTEK is riluzole. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the riluzole profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Rilutek
A generic version of RILUTEK was approved as riluzole by IMPAX LABS on January 29th, 2003.
Summary for RILUTEK
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 166 |
| Clinical Trials: | 31 |
| Patent Applications: | 4,192 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for RILUTEK |
| What excipients (inactive ingredients) are in RILUTEK? | RILUTEK excipients list |
| DailyMed Link: | RILUTEK at DailyMed |
Recent Clinical Trials for RILUTEK
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ning Jin | Phase 1 |
| Corestem, Inc. | Phase 3 |
| Zambon SpA | Phase 1 |
Pharmacology for RILUTEK
| Drug Class | Benzothiazole |
Anatomical Therapeutic Chemical (ATC) Classes for RILUTEK
US Patents and Regulatory Information for RILUTEK
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Covis | RILUTEK | riluzole | TABLET;ORAL | 020599-001 | Dec 12, 1995 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 RILUTEK
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Covis | RILUTEK | riluzole | TABLET;ORAL | 020599-001 | Dec 12, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for RILUTEK
| 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 RILUTEK
See the table below for patents covering RILUTEK around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Norway | 943256 | ⤷ Try a Trial | |
| Austria | 149833 | ⤷ Try a Trial | |
| European Patent Office | 0627919 | APPLICATION DE L'AMINO-2 TRIFLUOROMETHOXY-6 BENZOTHIAZOLE (RILUZOLE) POUR OBTENIR UN MEDICAMENT DESTINE AU TRAITEMENT DES MALADIES DU MOTONEURONE (APPLICATION OF 2-AMINO 6-TRIFLUOROMETHOXY BENZOTHIAZOLE (RILUZOLE) FOR OBTAINING A DRUG USEFUL IN THE TREATMENT OF MOTOR NEURON DISEASES) | ⤷ Try a Trial |
| Hungary | T70946 | ⤷ Try a Trial | |
| Spain | 2098558 | ⤷ Try a Trial | |
| France | 2688138 | APPLICATION DE L'AMINO-2 TRIFLUOROMETHOXY-6 BENZOTHIAZOLE POUR OBTENIR UN MEDICAMENT DESTINE AU TRAITEMENT DE LA SCLEROSE LATERALE AMYOTROPHIQUE. | ⤷ Try a Trial |
| South Korea | 100190296 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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