METAXALONE Drug Patent Profile
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When do Metaxalone patents expire, 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. There is one patent protecting this drug.
This drug has six patent family members in six countries.
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
International Patents: | 6 |
US Patents: | 1 |
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 |
Drug Sales Revenues: | Drug sales revenues 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
METAXALONE is protected by one US patents.
Patents protecting METAXALONE
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
International Patents for METAXALONE
See the table below for patents covering METAXALONE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2022539368 | 低用量のメタキサロン製剤 | ⤷ Try a Trial |
South Korea | 20220025815 | 용량이 감소된 메탁살론 제형 | ⤷ Try a Trial |
Brazil | 112021026371 | Formulações de metaxalona de dose reduzida | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2020263768 | ⤷ Try a Trial | |
European Patent Office | 3989946 | FORMULATIONS DE MÉTAXALONE À DOSE RÉDUITE (REDUCED DOSE METAXALONE FORMULATIONS) | ⤷ Try a Trial |
Australia | 2020307390 | Reduced dose metaxalone formulations | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |