DrugPatentWatch Database Preview
SOOLANTRA Drug Profile
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 sixty-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. Six suppliers are listed for this compound. Additional details are available on the ivermectin profile page.
Summary for SOOLANTRA
| International Patents: | 67 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 64 |
| Clinical Trials: | 5 |
| 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 |
|---|---|
| Catawba Research, LLC | Phase 3 |
| Zydus Worldwide DMCC | Phase 3 |
| University of California, San Diego | Phase 1/Phase 2 |
Recent Litigation for SOOLANTRA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Galderma Laboratories LP v. Teva Pharmaceuticals USA, Inc. | 2017-12-11 |
| Galderma Laboratories LP v. Perrigo UK Finco Limited Partnership | 2017-07-13 |
| Galderma Laboratories LP v. Actavis Laboratories UT Inc | 2017-04-21 |
Pharmacology for SOOLANTRA
| Drug Class | Antiparasitic Pediculicide |
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 | RX | Yes | Yes | See Pricing | See Pricing | Y | See Pricing | |||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | RX | Yes | Yes | See Pricing | See Pricing | See Pricing | ||||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | RX | Yes | Yes | See Pricing | See Pricing | Y | See Pricing | |||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | RX | Yes | Yes | See Pricing | See Pricing | See Pricing | ||||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | RX | Yes | Yes | See Pricing | See Pricing | Y | See Pricing | |||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | RX | Yes | Yes | See Pricing | See Pricing | See Pricing | ||||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | RX | Yes | Yes | See Pricing | See Pricing | Y | See Pricing | |||
| >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 | See Pricing | See Pricing |
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | See Pricing | See Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for SOOLANTRA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Cream | 1% | ➤ Subscribe | See Pricing |
International Patents for SOOLANTRA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20160061311 | See Pricing |
| Japan | 2012126738 | See Pricing |
| Australia | 2014287422 | See Pricing |
| Austria | 516037 | See Pricing |
| South Korea | 101187231 | See Pricing |
| Lithuania | C1620113 | See Pricing |
| Hong Kong | 1223841 | See Pricing |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SOOLANTRA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1620113 | PA2015033 | Lithuania | See Pricing | PRODUCT NAME: IVERMECTINUM; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402 |
| 1620113 | 300756 | Netherlands | See Pricing | 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 | C 2015 036 | Romania | See Pricing | 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 | 122015000079 | Germany | See Pricing | PRODUCT NAME: IVERMECTIN ZU SEINER VERWENDUNG FUER DIE BEHANDLUNG VON ROSAZEA; NAT. REGISTRATION NO/DATE: 92429.00.00 20150429; FIRST REGISTRATION: MALTA MA 117/01101 20150402 |
| 1620113 | 2015/046 | Ireland | See Pricing | PRODUCT NAME: IVERMECTIN; NAT REGISTRATION NO/DATE: PA0590/028/001 20150424; FIRST REGISTRATION NO/DATE: MA117/01101 20150402 |
| 1620113 | PA2015033,C1620113 | Lithuania | See Pricing | PRODUCT NAME: IVERMEKTINAS; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402 |
| 1620113 | 15C0069 | France | See Pricing | 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 |
