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SKELAXIN Drug Profile
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» See Plans and PricingWhen 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 are two patents 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 suppliers are listed for this compound. Additional details are available on the metaxalone profile page.
US ANDA 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: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 94 |
| Patent Applications: | 1,336 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SKELAXIN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SKELAXIN |
| DailyMed Link: | SKELAXIN at DailyMed |
Pharmacology for SKELAXIN
| Physiological Effect | Centrally-mediated Muscle Relaxation |
Paragraph IV (Patent) Challenges for SKELAXIN
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SKELAXIN | TABLET;ORAL | metaxalone | 013217 | 2004-11-04 |
US Patents and Regulatory Information for SKELAXIN
| 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 | Start Trial | Start Trial | Start Trial | ||||
| King Pharms | SKELAXIN | metaxalone | TABLET;ORAL | 013217-003 | Aug 30, 2002 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| King Pharms | SKELAXIN | metaxalone | TABLET;ORAL | 013217-003 | Aug 30, 2002 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| >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 SKELAXIN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2007094825 | Start Trial |
| Canada | 2626027 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
