Afamelanotide - Generic Drug Details
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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. One supplier is listed for this compound.
Summary for afamelanotide
| International Patents: | 34 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 26 |
| Clinical Trials: | 22 |
| Patent Applications: | 1,059 |
| What excipients (inactive ingredients) are in afamelanotide? | afamelanotide excipients list |
| DailyMed Link: | afamelanotide at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for afamelanotide
Generic Entry Date for afamelanotide*:
Constraining patent/regulatory exclusivity:
INDICATED TO INCREASE PAIN FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP) Dosage:
IMPLANT;SUBCUTANEOUS |
*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 afamelanotide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Clinuvel, Inc. | Phase 3 |
| Clinuvel (UK) Ltd. | Phase 2 |
| Clinuvel, Inc. | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for afamelanotide
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Clivunel Inc | SCENESSE | afamelanotide | IMPLANT;SUBCUTANEOUS | 210797-001 | Oct 8, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Clivunel Inc | SCENESSE | afamelanotide | IMPLANT;SUBCUTANEOUS | 210797-001 | Oct 8, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Clivunel Inc | SCENESSE | afamelanotide | IMPLANT;SUBCUTANEOUS | 210797-001 | Oct 8, 2019 | RX | Yes | Yes | ⤷ 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 |
EU/EMA Drug Approvals for afamelanotide
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Clinuvel Europe Limited | Scenesse | afamelanotide | EMEA/H/C/002548 Prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). |
Authorised | no | no | yes | 2014-12-22 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for afamelanotide
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Denmark | 2056855 | ⤷ Sign Up | |
| Japan | 5208504 | ⤷ Sign Up | |
| Slovenia | 2865422 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2008025094 | ⤷ Sign Up | |
| Slovenia | 2056855 | ⤷ Sign Up | |
| Canada | 2662163 | METHODE DE TRAITEMENT DE PHOTODERMATOSES (METHOD OF TREATMENT OF PHOTODERMATOSES) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for afamelanotide
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2865422 | CR 2018 00014 | Denmark | ⤷ Sign Up | PRODUCT NAME: AFAMELANOTID; REG. NO/DATE: EU/1/14/969 20141229 |
| 2865422 | 2018C/012 | Belgium | ⤷ Sign Up | PRODUCT NAME: AFAMELANOTIDE; AUTHORISATION NUMBER AND DATE: EU/1/14/969 20141229 |
| 2865422 | LUC00062 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: AFAMELANOTIDE ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (SCENESSE); AUTHORISATION NUMBER AND DATE: EU/1/14/969 20141229 |
| 2865422 | 1890011-8 | Sweden | ⤷ Sign Up | PRODUCT NAME: AFAMELANOTIDE; REG. NO/DATE: EU/1/14/969 20141229 |
| 2865422 | 2018/008 | Ireland | ⤷ Sign Up | PRODUCT NAME: AFAMELANOTIDE; REGISTRATION NO/DATE: EU/1/14/969 20141222 |
| 2865422 | 122018000148 | Germany | ⤷ Sign Up | PRODUCT NAME: AFAMELANOTID; REGISTRATION NO/DATE: EU/1/14/969 20141222 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
