SCENESSE Drug Patent Profile
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Which patents cover Scenesse, and when can generic versions of Scenesse launch?
Scenesse is a drug marketed by Clivunel Inc and is included in one NDA. There are two patents protecting this drug.
This drug has thirty-four patent family members in eighteen countries.
The generic ingredient in SCENESSE is afamelanotide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the afamelanotide profile page.
DrugPatentWatch® Generic Entry Outlook for Scenesse
Scenesse was eligible for patent challenges on October 8, 2023.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 8, 2026. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for SCENESSE
| International Patents: | 34 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 23 |
| Clinical Trials: | 2 |
| Patent Applications: | 1 |
| Drug Prices: | Drug price information for SCENESSE |
| What excipients (inactive ingredients) are in SCENESSE? | SCENESSE excipients list |
| DailyMed Link: | SCENESSE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SCENESSE
Generic Entry Date for SCENESSE*:
Constraining patent/regulatory exclusivity:
INDICATED TO INCREASE PAIN FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP) NDA:
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 SCENESSE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Clinuvel Europe Limited | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for SCENESSE
US Patents and Regulatory Information for SCENESSE
SCENESSE is protected by two US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SCENESSE is ⤷ Try a Trial.
This potential generic entry date is based on INDICATED TO INCREASE PAIN FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP).
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 SCENESSE
Methods of inducing melanogenesis in a subject
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: INCREASE PAIN-FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP)
Method of treatment of photodermatoses
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: INCREASE PAIN-FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP)
FDA Regulatory Exclusivity protecting SCENESSE
INDICATED TO INCREASE PAIN FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP)
Exclusivity Expiration: ⤷ Try a Trial
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
| 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 a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Clivunel Inc | SCENESSE | afamelanotide | IMPLANT;SUBCUTANEOUS | 210797-001 | Oct 8, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Clivunel Inc | SCENESSE | afamelanotide | IMPLANT;SUBCUTANEOUS | 210797-001 | Oct 8, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 SCENESSE
| 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 SCENESSE
See the table below for patents covering SCENESSE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2525476 | ⤷ Try a Trial | |
| Portugal | 2865422 | ⤷ Try a Trial | |
| Slovenia | 2056855 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SCENESSE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2865422 | 300926 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: AFAMELANOTIDE; REGISTRATION NO/DATE: EU/1/14/969 20141222 |
| 2865422 | CR 2018 00014 | Denmark | ⤷ Try a Trial | PRODUCT NAME: AFAMELANOTID; REG. NO/DATE: EU/1/14/969 20141229 |
| 2865422 | 405 8-2018 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: AFAMELANOTID; 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
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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