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Macimorelin acetate - Generic Drug Details
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What are the generic sources for macimorelin acetate and what is the scope of patent protection?
Macimorelin acetate
is the generic ingredient in one branded drug marketed by Novo and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Macimorelin acetate has seventy-three patent family members in thirty-one countries.
One supplier is listed for this compound.
Summary for macimorelin acetate
| International Patents: | 73 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 2 |
| DailyMed Link: | macimorelin acetate at DailyMed |
Pharmacology for macimorelin acetate
| Drug Class | Growth Hormone Secretagogue Receptor Agonist |
| Mechanism of Action | Growth Hormone Secretagogue Receptor Agonists |
US Patents and Regulatory Information for macimorelin acetate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novo | MACRILEN | macimorelin acetate | FOR SOLUTION;ORAL | 205598-001 | Dec 20, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Novo | MACRILEN | macimorelin acetate | FOR SOLUTION;ORAL | 205598-001 | Dec 20, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Novo | MACRILEN | macimorelin acetate | FOR SOLUTION;ORAL | 205598-001 | Dec 20, 2017 | 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 macimorelin acetate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 0196300 | Start Trial |
| Spain | 2250416 | Start Trial |
| Hungary | 229233 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for macimorelin acetate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1289951 | 122019000074 | Germany | Start Trial | PRODUCT NAME: MACIMORELIN, OPTIONAL IN FORM EINER ARZNEIMITTELZUSAMMENSETZUNG, OPTIONAL IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, INSBESONDERE MACIMORELIN ACETAT.; REGISTRATION NO/DATE: EU/1/18/1337 20190111 |
| 1289951 | CA 2019 00037 | Denmark | Start Trial | PRODUCT NAME: MACIMORELIN, EN FARMACEUTISK SAMMENSAETNING DERAF ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1337 20190115 |
| 1289951 | 132019000000099 | Italy | Start Trial | PRODUCT NAME: MACIMORELINA, OPZIONALMENTE NELLA FORMA DI UNA COMPOSIZIONE FARMACEUTICA, OPZIONALMENTE NELLA FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE, COMPRESA MACIMORELINA ACETATO(MACIMORELIN AETERNA ZENTARIS - MACIMORELINA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1337, 20190115 |
| >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.
ISSN: 2162-2639
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