TIGLUTIK KIT Drug Patent Profile
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Which patents cover Tiglutik Kit, and when can generic versions of Tiglutik Kit launch?
Tiglutik Kit is a drug marketed by Italfarmaco Spa and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has twenty-five patent family members in twenty-one countries.
The generic ingredient in TIGLUTIK KIT is riluzole. There are nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the riluzole profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tiglutik Kit
A generic version of TIGLUTIK KIT was approved as riluzole by IMPAX LABS on January 29th, 2003.
Summary for TIGLUTIK KIT
| International Patents: | 25 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | TIGLUTIK KIT at DailyMed |
Pharmacology for TIGLUTIK KIT
| Drug Class | Benzothiazole |
Anatomical Therapeutic Chemical (ATC) Classes for TIGLUTIK KIT
Paragraph IV (Patent) Challenges for TIGLUTIK KIT
| 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 TIGLUTIK KIT
TIGLUTIK KIT is protected by one US patents.
Patents protecting TIGLUTIK KIT
Riluzole aqueous suspensions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING AMYOTROPHIC LATERAL SCLEROSIS IN A PATIENT IN NEED OF SUCH TREATMENT, SAID METHOD COMPRISING ADMINISTERING TO SAID PATIENT AN EFFECTIVE AMOUNT OF A SUSPENSION ACCORDING TO CLAIM 1
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Italfarmaco Spa | TIGLUTIK KIT | riluzole | SUSPENSION;ORAL | 209080-001 | Sep 5, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for TIGLUTIK KIT
See the table below for patents covering TIGLUTIK KIT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2012520254 | See Plans and Pricing | |
| Poland | 2405890 | See Plans and Pricing | |
| Croatia | P20130021 | See Plans and Pricing | |
| Denmark | 2405890 | See Plans and Pricing | |
| >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.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2022, www.DrugPatentWatch.com.
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