SKELAXIN Drug Patent Profile
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When do Skelaxin patents expire, and when can generic versions of Skelaxin launch?
Skelaxin is a drug marketed by King Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has two patent family members in two countries.
The generic ingredient in SKELAXIN is metaxalone. There are twenty drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the metaxalone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Skelaxin
A generic version of SKELAXIN was approved as metaxalone by SANDOZ on March 31st, 2010.
Summary for SKELAXIN
| International Patents: | 2 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 118 |
| Patent Applications: | 3,172 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SKELAXIN |
| What excipients (inactive ingredients) are in SKELAXIN? | SKELAXIN excipients list |
| DailyMed Link: | SKELAXIN at DailyMed |
Paragraph IV (Patent) Challenges for SKELAXIN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| SKELAXIN | Tablets | metaxalone | 800 mg | 013217 | 1 | 2004-11-04 |
US Patents and Regulatory Information for SKELAXIN
SKELAXIN is protected by one US patents.
Patents protecting SKELAXIN
Metaxalone products, method of manufacture, and method of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF MUSCULOSKELETAL CONDITIONS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| King Pharms | SKELAXIN | metaxalone | TABLET;ORAL | 013217-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| King Pharms | SKELAXIN | metaxalone | TABLET;ORAL | 013217-003 | Aug 30, 2002 | 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 SKELAXIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| King Pharms | SKELAXIN | metaxalone | TABLET;ORAL | 013217-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| King Pharms | SKELAXIN | metaxalone | TABLET;ORAL | 013217-003 | Aug 30, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| King Pharms | SKELAXIN | metaxalone | TABLET;ORAL | 013217-003 | Aug 30, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SKELAXIN
See the table below for patents covering SKELAXIN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2007094825 | ⤷ Try a Trial | |
| Canada | 2626027 | PRODUITS A BASE DE METAXALONE, PROCEDE DE PREPARATION ET PROCEDE D'UTILISATION (METAXALONE PRODUCTS, METHOD OF MANUFACTURE, AND METHOD OF USE) | ⤷ Try a Trial |
| >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.
ISSN: 2162-2639
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
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