SOOLANTRA Drug Patent Profile
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When 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 twelve patents protecting this drug and one Paragraph IV challenge.
This drug has seventy-seven patent family members in twenty-eight countries.
The generic ingredient in SOOLANTRA is ivermectin. There are five drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the ivermectin profile page.
DrugPatentWatch® 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: | 77 |
US Patents: | 12 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 103 |
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 |
What excipients (inactive ingredients) are in SOOLANTRA? | SOOLANTRA excipients list |
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 |
Catawba Research, LLC | Phase 3 |
Zydus Worldwide DMCC | Phase 3 |
Pharmacology for SOOLANTRA
Drug Class | Antiparasitic Pediculicide |
Anatomical Therapeutic Chemical (ATC) Classes for SOOLANTRA
Paragraph IV (Patent) Challenges for SOOLANTRA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
SOOLANTRA | Cream | ivermectin | 1% | 206255 | 1 | 2016-12-30 |
US Patents and Regulatory Information for SOOLANTRA
SOOLANTRA is protected by twelve US patents.
Patents protecting SOOLANTRA
Treatment of papulopustular rosacea with ivermectin
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Treatment of papulopustular rosacea with ivermectin
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Treatment of inflammatory lesions of rosacea with ivermectin
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Treatment of papulopustular rosacea with ivermectin
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Treatment of papulopustular rosacea with ivermectin
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | 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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial |
Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SOOLANTRA
See the table below for patents covering SOOLANTRA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Cyprus | 1111797 | ⤷ Try a Trial | |
Mexico | PA05011208 | USO DE IVERMECTINA PARA EL TRATAMIENTO DE DESORDENES DERMATOLOGICOS. (TOPICAL FORMULATION OF IVERMECTIN FOR THE TREATMENT OF DERMATOLOGICAL CONDITIONS.) | ⤷ Try a Trial |
Israel | 243314 | טיפול בנגעים דלקתיים של רוזצאה על ידי איוורמקטין (Treatment of inflammatory lesions of rosacea with ivermectin) | ⤷ Try a Trial |
Japan | 2006524212 | ⤷ Try a Trial | |
South Korea | 101187231 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SOOLANTRA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1620113 | CA 2015 00045 | Denmark | ⤷ Try a 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 | C 2015 036 | Romania | ⤷ Try a Trial | PRODUCT NAME: IVERMECTINA; NATIONAL AUTHORISATION NUMBER: RO7674/2015/01, RO7674/2015/02, RO7674/2015/03, RO7674/2015/04, RO7674/2015/05; DATE OF NATIONAL AUTHORISATION: 20150526; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): MALTA MA117/01101; DATE OF FIRST AUTHORISATION IN EEA: 20150402 |
1620113 | 56/2015 | Austria | ⤷ Try a Trial | PRODUCT NAME: IVERMECTIN; NAT. REGISTRATION NO/DATE: 136170 20150602; FIRST REGISTRATION: MT MA 117/01101 20150402 |
1620113 | C01620113/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: IVERMECTINUM; REGISTRATION NO/DATE: AUTORISATION SWISSMEDIC 65561 20.12.2016 |
1620113 | C300756 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MA117/01101 20150402 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |