Riluzole - Generic Drug Details
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What are the generic drug sources for riluzole and what is the scope of freedom to operate?
Riluzole
is the generic ingredient in four branded drugs marketed by Aquestive, Italfarmaco Sa, Covis, Alkem Labs Ltd, Apotex Corp, Daito Pharms Co Ltd, Glenmark Pharms Ltd, Impax Labs, Kenton, Mylan Pharms Inc, and Sun Pharm Inds Ltd, and is included in eleven NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Riluzole has one hundred and eighty-seven patent family members in twenty-nine countries.
There are nine drug master file entries for riluzole. Nine suppliers are listed for this compound.
Summary for riluzole
| International Patents: | 187 |
| US Patents: | 3 |
| Tradenames: | 4 |
| Applicants: | 11 |
| NDAs: | 11 |
| Drug Master File Entries: | 9 |
| Finished Product Suppliers / Packagers: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 164 |
| Clinical Trials: | 128 |
| Patent Applications: | 6,728 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for riluzole |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for riluzole |
| What excipients (inactive ingredients) are in riluzole? | riluzole excipients list |
| DailyMed Link: | riluzole at DailyMed |
Recent Clinical Trials for riluzole
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| InFlectis BioScience | Phase 2 |
| NeuroSense Therapeutics Ltd. | Phase 2 |
| University of Utah | Phase 2 |
Pharmacology for riluzole
| Drug Class | Benzothiazole |
Medical Subject Heading (MeSH) Categories for riluzole
Paragraph IV (Patent) Challenges for RILUZOLE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TIGLUTIK KIT | Oral Suspension | riluzole | 50 mg/10 mL | 209080 | 1 | 2021-03-12 |
US Patents and Regulatory Information for riluzole
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Pharms Inc | RILUZOLE | riluzole | TABLET;ORAL | 203042-001 | Jul 1, 2013 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Alkem Labs Ltd | RILUZOLE | riluzole | TABLET;ORAL | 204048-001 | Mar 30, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sun Pharm Inds Ltd | RILUZOLE | riluzole | TABLET;ORAL | 091417-001 | Jun 18, 2013 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Aquestive | EXSERVAN | riluzole | FILM;ORAL | 212640-001 | Nov 22, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Italfarmaco Sa | TIGLUTIK KIT | riluzole | SUSPENSION;ORAL | 209080-001 | Sep 5, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Impax Labs | RILUZOLE | riluzole | TABLET;ORAL | 076173-001 | Jan 29, 2003 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| 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 riluzole
| 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 |
| Aquestive | EXSERVAN | riluzole | FILM;ORAL | 212640-001 | Nov 22, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
| Aquestive | EXSERVAN | riluzole | FILM;ORAL | 212640-001 | Nov 22, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for riluzole
| 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 riluzole
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 3210601 | FILMS À BASE D'OXYDE DE POLYÉTHYLÈNE ET SYSTÈMES D'ADMINISTRATION DE MÉDICAMENT FABRIQUÉS À PARTIR DE CEUX-CI (POLYETHYLENE OXIDE-BASED FILMS AND DRUG DELIVERY SYSTEM MADE THEREFROM) | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 03012531 | ⤷ Try a Trial | |
| Japan | 2007500252 | ⤷ Try a Trial | |
| China | 101321511 | Topical film compositions for delivery of actives | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2008100375 | ⤷ Try a Trial | |
| Japan | 2010504993 | ⤷ Try a Trial | |
| Japan | 4795639 | ⤷ 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.
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