macrilen Drug Patent Profile
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When do Macrilen patents expire, and what generic alternatives are available?
Macrilen is a drug marketed by Novo and is included in one NDA. There is one patent protecting this drug.
This drug has eleven patent family members in ten countries.
The generic ingredient in MACRILEN is macimorelin acetate. One supplier is listed for this compound. Additional details are available on the macimorelin acetate profile page.
DrugPatentWatch® Generic Entry Outlook for Macrilen
Macrilen was eligible for patent challenges on December 20, 2021.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 20, 2024. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for macrilen
| International Patents: | 11 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 5 |
| Clinical Trials: | 2 |
| Patent Applications: | 34 |
| Drug Prices: | Drug price information for macrilen |
| What excipients (inactive ingredients) are in macrilen? | macrilen excipients list |
| DailyMed Link: | macrilen at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for macrilen
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for macrilen
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| VA Office of Research and Development | Phase 3 |
| Novo Nordisk A/S | Phase 3 |
| AEterna Zentaris | Phase 3 |
Pharmacology for macrilen
| Drug Class | Growth Hormone Secretagogue Receptor Agonist |
| Mechanism of Action | Growth Hormone Secretagogue Receptor Agonists |
US Patents and Regulatory Information for macrilen
macrilen is protected by one US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of macrilen is ⤷ Sign Up.
This potential generic entry date is based on FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY (AGHD).
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting macrilen
Methods and kits to diagnose growth hormone deficiency by oral administration of EP 1572 or EP 1573 compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY BY MEASURING THE LEVEL OF GROWTH HORMONE AFTER ORAL ADMINISTRATION OF MACIMORELIN
FDA Regulatory Exclusivity protecting macrilen
FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY (AGHD)
Exclusivity Expiration: ⤷ Sign Up
| 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 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novo | MACRILEN | macimorelin acetate | FOR SOLUTION;ORAL | 205598-001 | Dec 20, 2017 | 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 macrilen
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novo | MACRILEN | macimorelin acetate | FOR SOLUTION;ORAL | 205598-001 | Dec 20, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for macrilen
See the table below for patents covering macrilen around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 4932132 | ⤷ Sign Up | |
| Germany | 60128494 | ⤷ Sign Up | |
| Cyprus | 1107710 | ⤷ Sign Up | |
| Bulgaria | 107379 | ⤷ Sign Up | |
| China | 1232507 | ⤷ Sign Up | |
| Czech Republic | 20024095 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2007093820 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for macrilen
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1289951 | CA 2019 00037 | Denmark | ⤷ Sign Up | PRODUCT NAME: MACIMORELIN, EN FARMACEUTISK SAMMENSAETNING DERAF ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1337 20190115 |
| 1289951 | C201930046 | Spain | ⤷ Sign Up | PRODUCT NAME: MACIMORELINA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1337; DATE OF AUTHORISATION: 20190111; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1337; DATE OF FIRST AUTHORISATION IN EEA: 20190111 |
| 1289951 | 122019000074 | Germany | ⤷ Sign Up | 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 | 132019000000099 | Italy | ⤷ Sign Up | 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 |
| 1289951 | 300999 | Netherlands | ⤷ Sign Up | PRODUCT NAME: MACIMORELIN; REGISTRATION NO/DATE: EU/1/18/1337 20190115 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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