METAXALONE Drug Patent Profile
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Which patents cover Metaxalone, and what generic alternatives are available?
Metaxalone is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms, Appco, Ingenus Pharms Llc, Lannett Co Inc, Mountain, Primus Pharms, Sandoz, and Sciegen Pharms Inc. and is included in nine NDAs.
The generic ingredient in METAXALONE is metaxalone. There are twenty drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the metaxalone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Metaxalone
A generic version of METAXALONE was approved as metaxalone by SANDOZ on March 31st, 2010.
Summary for METAXALONE
US Patents: | 0 |
Applicants: | 9 |
NDAs: | 9 |
Finished Product Suppliers / Packagers: | 33 |
Raw Ingredient (Bulk) Api Vendors: | 118 |
Clinical Trials: | 2 |
Patent Applications: | 2,705 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for METAXALONE |
What excipients (inactive ingredients) are in METAXALONE? | METAXALONE excipients list |
DailyMed Link: | METAXALONE at DailyMed |
Recent Clinical Trials for METAXALONE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Rothman Institute Orthopaedics | N/A |
Montefiore Medical Center | Phase 4 |
Pharmacology for METAXALONE
Drug Class | Muscle Relaxant |
Physiological Effect | Centrally-mediated Muscle Relaxation |
Paragraph IV (Patent) Challenges for METAXALONE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
SKELAXIN | Tablets | metaxalone | 800 mg | 013217 | 1 | 2004-11-04 |
US Patents and Regulatory Information for METAXALONE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Actavis Labs Fl Inc | METAXALONE | metaxalone | TABLET;ORAL | 203695-001 | Jun 15, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Primus Pharms | METAXALONE | metaxalone | TABLET;ORAL | 022503-001 | Jun 1, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ingenus Pharms Llc | METAXALONE | metaxalone | TABLET;ORAL | 213836-001 | Oct 21, 2020 | DISCN | No | No | ⤷ 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 |