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MACRILEN Drug Profile
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When do Macrilen patents expire, and when can generic versions of Macrilen launch?
Macrilen is a drug marketed by Novo and is included in one NDA. There are two patents protecting this drug.
This drug has seventy-three patent family members in thirty-one 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.
US ANDA Litigation and Generic Entry Outlook for Macrilen
Macrilen will be eligible for patent challenges on December 20th, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 20th, 2024. This may change due to patent challenges or generic licensing.
Summary for MACRILEN
| International Patents: | 73 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 8 |
| Patent Applications: | 19 |
| Drug Prices: | Drug price information for MACRILEN |
| DailyMed Link: | MACRILEN at DailyMed |
Generic Entry Opportunity Date for MACRILEN
Generic Entry Date for MACRILEN*:
Constraining patent/regulatory exclusivity:
FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY (AGHD) NDA:
Dosage:
FOR SOLUTION;ORAL |
*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.
Pharmacology for MACRILEN
| Drug Class | Growth Hormone Secretagogue Receptor Agonist |
| Mechanism of Action | Growth Hormone Secretagogue Receptor Agonists |
Synonyms for MACRILEN
| 2-amino-N-[(2R)-1-[[(1R)-1-formamido-2-(1H-indol-3-yl)ethyl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]-2-methylpropanamide |
| 2-Amino-N-{(R)-1-[(R)-1-formylamino-2-(1H-indol-3-yl)-ethylcarbamoyl]-2-1H-indol-3-yl-ethyl}-2-methyl-propionamide |
| 381231-18-1 |
| 8680B21W73 |
| 945212-59-9 |
| 945212-59-9 (acetate salt) |
| AEZS 130 |
| AEZS-130 |
| AEZS130 |
| Aib-DTrp-DgTrp-CHO |
| Aib-Trp-gTrp-CHO acetate |
| AQZ1003RMG |
| ARD 07 acetate |
| ARD-07 |
| BDBM50125886 |
| CHEMBL2364617 |
| CHEMBL278623 |
| D-87575 |
| D-87575 acetate |
| D-Tryptophanamide, 2-methylalanyl-N-((1R)-1-(formylamino)-2-(1H-indol-3-yl)ethyl)-, acetate (1:1) |
| D10562 |
| D10563 |
| DB13074 |
| DTXSID40241516 |
| EP 1572 |
| EP 1572 acetate |
| EP-01572 |
| EP-1572 |
| EP1572 |
| GTPL9745 |
| JMV 1843 |
| JMV-1843 |
| JMV1843 |
| Macimorelin |
| Macimorelin (USAN) |
| Macimorelin [USAN:INN] |
| Macimorelin acetate |
| Macimorelin acetate (USAN) |
| Macimorelin acetate [USAN] |
| Macrilen (TN) |
| N2-(2-amino-2-methylpropanoyl-N1-((1R)-1-formamido-2-(1H-indol-3-yl)ethyl)- D-tryptophanamide acetate |
| SB16909 |
| SB16910 |
| SCHEMBL1984708 |
| UMV1843 |
| UNII-8680B21W73 |
| UNII-AQZ1003RMG |
US Patents and Regulatory Information for MACRILEN
| 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 | ||||
| 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 MACRILEN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1289951 | Start Trial |
| Spain | 2404582 | Start Trial |
| Spain | 2288724 | Start Trial |
| Israel | 153067 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for MACRILEN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 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 | 300999 | Netherlands | Start Trial | PRODUCT NAME: MACIMORELIN; REGISTRATION NO/DATE: EU/1/18/1337 20190115 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
