Retapamulin - Generic Drug Details
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What are the generic sources for retapamulin and what is the scope of freedom to operate?
Retapamulin
is the generic ingredient in one branded drug marketed by Almirall and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Retapamulin has thirteen patent family members in six countries.
Summary for retapamulin
| International Patents: | 13 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 73 |
| Clinical Trials: | 16 |
| Patent Applications: | 1,254 |
| What excipients (inactive ingredients) are in retapamulin? | retapamulin excipients list |
| DailyMed Link: | retapamulin at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for retapamulin
*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 retapamulin
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| New York University School of Medicine | Phase 3 |
| NYU Langone Health | Phase 3 |
| GlaxoSmithKline | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for retapamulin
US Patents and Regulatory Information for retapamulin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Almirall | ALTABAX | retapamulin | OINTMENT;TOPICAL | 022055-001 | Apr 12, 2007 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Almirall | ALTABAX | retapamulin | OINTMENT;TOPICAL | 022055-001 | Apr 12, 2007 | DISCN | Yes | No | ⤷ 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 |
Expired US Patents for retapamulin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Almirall | ALTABAX | retapamulin | OINTMENT;TOPICAL | 022055-001 | Apr 12, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Almirall | ALTABAX | retapamulin | OINTMENT;TOPICAL | 022055-001 | Apr 12, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Almirall | ALTABAX | retapamulin | OINTMENT;TOPICAL | 022055-001 | Apr 12, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for retapamulin
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Glaxo Group Ltd | Altargo | retapamulin | EMEA/H/C/000757 Short term treatment of the following superficial skin infections:, , , impetigo;, infected small lacerations, abrasions or sutured wounds., , , See sections 4.4 and 5.1 for important information regarding the clinical activity of retapamulin against different types of Staphylococcus aureus., , Consideration should be given to official guidance on the appropriate use of antibacterial agents., |
Withdrawn | no | no | no | 2007-05-24 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for retapamulin
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2012236850 | NEW METHOD OF PREPARATION, SALT, COMPOSITION AND USE | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2005023257 | ⤷ Sign Up | |
| Japan | 5460947 | ⤷ Sign Up | |
| Japan | 2007504231 | ⤷ Sign Up | |
| Japan | 5719331 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for retapamulin
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1028961 | SPC/GB07/061 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: RETAPAMULIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/07/390/001 20070524; UK EU/1/07/390/002 20070524; UK EU/1/07/390/003 20070524; UK EU/1/07/390/004 20070524 |
| 1028961 | C01028961/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: RETAPAMULIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58641 04.08.2009 |
| 1028961 | 07C0057 | France | ⤷ Sign Up | PRODUCT NAME: RETAPAMULIN; REGISTRATION NO/DATE IN FRANCE: EU/1/07/390/001 DU 20070524; REGISTRATION NO/DATE AT EEC: EU/1/07/390/001 DU 20070524 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
