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SOOLANTRA Drug Profile
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» See Plans and PricingWhen do Soolantra patents expire, and when can generic versions of Soolantra launch?
Soolantra is a drug marketed by Galderma Labs Lp and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.
This drug has seventy-two patent family members in twenty-eight countries.
The generic ingredient in SOOLANTRA is ivermectin. There are five drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ivermectin profile page.
US ANDA Litigation and Generic Entry Outlook for Soolantra
A generic version of SOOLANTRA was approved as ivermectin by EDENBRIDGE PHARMS on October 24th, 2014.
Summary for SOOLANTRA
| International Patents: | 72 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 64 |
| Clinical Trials: | 6 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SOOLANTRA |
| Drug Sales Revenues: | Drug sales revenues for SOOLANTRA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SOOLANTRA |
| DailyMed Link: | SOOLANTRA at DailyMed |
Recent Clinical Trials for SOOLANTRA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Phase 2 |
| Zydus Worldwide DMCC | Phase 3 |
| Catawba Research, LLC | Phase 3 |
Pharmacology for SOOLANTRA
| Drug Class | Antiparasitic Pediculicide |
Paragraph IV (Patent) Challenges for SOOLANTRA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SOOLANTRA | CREAM;TOPICAL | ivermectin | 206255 | 2016-12-30 |
US Patents and Regulatory Information for SOOLANTRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| >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 SOOLANTRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | Start Trial | Start Trial |
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SOOLANTRA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2018184437 | Start Trial |
| Mexico | PA05011208 | Start Trial |
| Chile | 2016000009 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2015006305 | Start Trial |
| Russian Federation | 2633076 | Start Trial |
| South Korea | 20060004667 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SOOLANTRA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1620113 | CA 2015 00045 | Denmark | Start Trial | PRODUCT NAME: IVERMECTIN, 22, 23-DIHYDROAVERMECTINB1A + 22,23-DIHRODROAVERMECTIN B1B FOR USE IN THE TREATMNET OF RESACEA; NAT. REG. NO/DATE: 54123 20150422; FIRST REG. NO/DATE: MT MA 117/01101 20150402 |
| 1620113 | PA2015033,C1620113 | Lithuania | Start Trial | PRODUCT NAME: IVERMEKTINAS; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402 |
| 1620113 | 2015/046 | Ireland | Start Trial | PRODUCT NAME: IVERMECTIN; NAT REGISTRATION NO/DATE: PA0590/028/001 20150424; FIRST REGISTRATION NO/DATE: MA117/01101 20150402 |
| 1620113 | 300756 | Netherlands | Start Trial | PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN DE BEHANDELING VAN ROSACEA; FIRST REGISTRATION NO/DATE: MA117/01101 20150402; NATIONAL REGISTRATION NO/DATE: RVG 115310 20150504 |
| 1620113 | C300756 | Netherlands | Start Trial | PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MA117/01101 20150402 |
| 1620113 | 15C0069 | France | Start Trial | PRODUCT NAME: IVERMECTINE; NAT. REGISTRATION NO/DATE: NL 44511 20150721; FIRST REGISTRATION: MT - MA 117/01101 20150402 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
