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, Ingenus Pharms Llc, Lannett Co Inc, Mountain, Primus Pharms, Rising, Sandoz, and Sciegen Pharms. and is included in nine NDAs. There are two patents protecting this drug.
This drug has eight patent family members in six countries.
The generic ingredient in METAXALONE is metaxalone. There are twenty drug master file entries for this compound. Thirty-four 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.
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Questions you can ask:
- What is the 5 year forecast for METAXALONE?
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Summary for METAXALONE
| International Patents: | 8 |
| US Patents: | 2 |
| Applicants: | 9 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 34 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 5 |
| Patent Applications: | 2,905 |
| Drug Prices: | Drug price information for METAXALONE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases 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 |
|---|---|
| ClinOhio Research Services, LLC | PHASE4 |
| Primus Pharmaceuticals | PHASE4 |
| Sun Valley Arthritis Center | PHASE4 |
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 two US patents.
| 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 | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Primus Pharms | METAXALONE | metaxalone | TABLET;ORAL | 022503-001 | Jun 1, 2015 | RX | Yes | Yes | 11,918,559 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Lannett Co Inc | METAXALONE | metaxalone | TABLET;ORAL | 204770-001 | Nov 22, 2016 | AB | RX | No | No | ⤷ 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 METAXALONE
See the table below for patents covering METAXALONE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2020307390 | ⤷ Start Trial | |
| Brazil | 112021026371 | ⤷ Start Trial | |
| European Patent Office | 3989946 | ⤷ Start 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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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