➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Boehringer Ingelheim
Merck
Baxter
Colorcon

Last Updated: October 17, 2021

DrugPatentWatch Database Preview

Afamelanotide - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

What are the generic sources for afamelanotide and what is the scope of patent protection?

Afamelanotide is the generic ingredient in one branded drug marketed by Clivunel Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Afamelanotide has thirty-four patent family members in eighteen countries.

There is one drug master file entry for afamelanotide.

Summary for afamelanotide
International Patents:34
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Raw Ingredient (Bulk) Api Vendors: 12
Clinical Trials: 16
Patent Applications: 738
What excipients (inactive ingredients) are in afamelanotide?afamelanotide excipients list
DailyMed Link:afamelanotide at DailyMed
Recent Clinical Trials for afamelanotide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Clinuvel Pharmaceuticals LimitedPhase 1
Clinuvel Pharmaceuticals LimitedPhase 2
Clinuvel Pharmaceuticals LimitedPhase 3

See all afamelanotide clinical trials

US Patents and Regulatory Information for afamelanotide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Clivunel Inc SCENESSE afamelanotide IMPLANT;SUBCUTANEOUS 210797-001 Oct 8, 2019 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Clivunel Inc SCENESSE afamelanotide IMPLANT;SUBCUTANEOUS 210797-001 Oct 8, 2019 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Clivunel Inc SCENESSE afamelanotide IMPLANT;SUBCUTANEOUS 210797-001 Oct 8, 2019 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Clivunel Inc SCENESSE afamelanotide IMPLANT;SUBCUTANEOUS 210797-001 Oct 8, 2019 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for afamelanotide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2865422 CA 2018 00014 Denmark ⤷  Try it Free PRODUCT NAME: AFAMELANOTIDE SAMT FARMACEUTISK ACCEPTABLE SALTE ELLER HYDRATER HERAF; REG. NO/DATE: EU/1/14/969 20141229
2865422 LUC00062 Luxembourg ⤷  Try it Free PRODUCT NAME: AFAMELANOTIDE ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (SCENESSE); AUTHORISATION NUMBER AND DATE: EU/1/14/969 20141229
2865422 C201830012 Spain ⤷  Try it Free PRODUCT NAME: AFAMELANOTIDA; NATIONAL AUTHORISATION NUMBER: EU/1/14/969; DATE OF AUTHORISATION: 20141222; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/969; DATE OF FIRST AUTHORISATION IN EEA: 20141222
2865422 1890011-8 Sweden ⤷  Try it Free PRODUCT NAME: AFAMELANOTIDE; REG. NO/DATE: EU/1/14/969 20141229
2865422 18C1014 France ⤷  Try it Free PRODUCT NAME: AFAMELANOTIDE; REGISTRATION NO/DATE: EU 1/14/969 20141229
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Boehringer Ingelheim
Merck
Baxter
Colorcon

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.