RILUZOLE Drug Patent Profile
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When do Riluzole patents expire, and what generic alternatives are available?
Riluzole is a drug marketed by 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 nine NDAs.
The generic ingredient in RILUZOLE 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 Riluzole
A generic version of RILUZOLE was approved as riluzole by IMPAX LABS on January 29th, 2003.
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Questions you can ask:
- What is the 5 year forecast for RILUZOLE?
- What are the global sales for RILUZOLE?
- What is Average Wholesale Price for RILUZOLE?
Summary for RILUZOLE
| US Patents: | 0 |
| Applicants: | 8 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 164 |
| Clinical Trials: | 130 |
| Patent Applications: | 4,188 |
| Drug Prices: | Drug price information 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 |
|---|---|
| Mario Negri Institute for Pharmacological Research | Phase 2/Phase 3 |
| University of Sydney | Phase 2/Phase 3 |
| FightMND | Phase 2/Phase 3 |
Pharmacology for RILUZOLE
| Drug Class | Benzothiazole |
Medical Subject Heading (MeSH) Categories for RILUZOLE
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alkem Labs Ltd | RILUZOLE | riluzole | SUSPENSION;ORAL | 216035-001 | Aug 22, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Kenton | RILUZOLE | riluzole | TABLET;ORAL | 206045-001 | Dec 9, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Daito Pharms Co Ltd | RILUZOLE | riluzole | TABLET;ORAL | 204430-001 | Oct 16, 2018 | DISCN | No | No | ⤷ 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 |
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 |
