MAXALT Drug Patent Profile
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Which patents cover Maxalt, and what generic alternatives are available?
Maxalt is a drug marketed by Organon Llc and Organon and is included in two NDAs.
The generic ingredient in MAXALT is rizatriptan benzoate. There are twenty-two drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the rizatriptan benzoate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Maxalt
A generic version of MAXALT was approved as rizatriptan benzoate by AUROBINDO PHARMA LTD on December 31st, 2012.
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Summary for MAXALT
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 114 |
| Clinical Trials: | 9 |
| Patent Applications: | 725 |
| Drug Prices: | Drug price information for MAXALT |
| What excipients (inactive ingredients) are in MAXALT? | MAXALT excipients list |
| DailyMed Link: | MAXALT at DailyMed |
Recent Clinical Trials for MAXALT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Robert W. Baloh | Phase 2/Phase 3 |
| Henry M. Jackson Foundation for the Advancement of Military Medicine | N/A |
| Beth Israel Deaconess Medical Center | Phase 4 |
Pharmacology for MAXALT
| Drug Class | Serotonin-1b and Serotonin-1d Receptor Agonist |
| Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Paragraph IV (Patent) Challenges for MAXALT
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| MAXALT | Tablets | rizatriptan benzoate | 5 mg and 10 mg | 020864 | 1 | 2004-09-02 |
US Patents and Regulatory Information for MAXALT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Organon Llc | MAXALT | rizatriptan benzoate | TABLET;ORAL | 020864-001 | Jun 29, 1998 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Organon | MAXALT-MLT | rizatriptan benzoate | TABLET, ORALLY DISINTEGRATING;ORAL | 020865-002 | Jun 29, 1998 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Organon Llc | MAXALT | rizatriptan benzoate | TABLET;ORAL | 020864-002 | Jun 29, 1998 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Organon | MAXALT-MLT | rizatriptan benzoate | TABLET, ORALLY DISINTEGRATING;ORAL | 020865-001 | Jun 29, 1998 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 MAXALT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Organon Llc | MAXALT | rizatriptan benzoate | TABLET;ORAL | 020864-001 | Jun 29, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Organon Llc | MAXALT | rizatriptan benzoate | TABLET;ORAL | 020864-002 | Jun 29, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Organon Llc | MAXALT | rizatriptan benzoate | TABLET;ORAL | 020864-002 | Jun 29, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Organon Llc | MAXALT | rizatriptan benzoate | TABLET;ORAL | 020864-001 | Jun 29, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for MAXALT
See the table below for patents covering MAXALT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 1038681 | ⤷ Sign Up | |
| Hungary | 211516 | ⤷ Sign Up | |
| Latvia | 12090 | IMIDAZOLA, TRIAZOLA UN TETRAZOLA ATVASINĀJUMI | ⤷ Sign Up |
| Israel | 100756 | Imidazole triazole and tetrazole derivatives their preparation and pharmaceutical compositions containing them | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MAXALT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0497512 | 28/1998 | Austria | ⤷ Sign Up | PRODUCT NAME: RIZATRIPTAN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE RIZATRIPTANBENZOAT; NAT. REGISTRATION NO/DATE: 1-22636 - 1-22639 19980709; FIRST REGISTRATION: NL 21815 - 21818 19980211 |
| 0497512 | C980019 | Netherlands | ⤷ Sign Up | PRODUCT NAME: RIZATRIPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT, IN HET BIJZOND ER RIZATRIPTAN-BENZOAAT; REGISTRATION NO/DATE: RVG 21815 - RVG 21818 19980211 |
| 0497512 | SPC/GB98/035 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: RIZATRIPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY RIZATRIPTAN BENZOATE; REGISTERED: NL 21815 19980211; NL 21816 19980211; NL 21817 19980211; NL 21818 19980211; UK 00025/0369 19980624; UK 00025/0370 19980624; UK 00025/0371 19980624; UK 00025/0372 19980624 |
| 0497512 | 9891028-4 | Sweden | ⤷ Sign Up | PRODUCT NAME: RIZATRIPTAN, N.N-DIMETYL-2-(5-(1, 2, 4-TRIAZOL-1-YLMETYL)-1H-INDOL-3-YL)ET)-1H-I, EVENTUELLT I FORM AV ETT FARMACEUTISKT GODTAGBART SALT, SPECIELLT DA RIZATRIPTANBENSOAT |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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