DrugPatentWatch Database Preview
MACRILEN Drug Profile
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-two 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.
Summary for MACRILEN
| International Patents: | 72 |
| 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 | ||||
| >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 |
|---|---|---|
| Bulgaria | 110771 | Start Trial |
| Hong Kong | 1056555 | Start Trial |
| Japan | 4852728 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for MACRILEN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
