SOOLANTRA Drug Patent Profile
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Which patents cover Soolantra, and what generic alternatives are available?
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. Twenty 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.
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Summary for SOOLANTRA
| International Patents: | 77 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 103 |
| Clinical Trials: | 6 |
| 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 |
| 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 | 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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Treatment of papulopustular rosacea with ivermectin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Treatment of inflammatory lesions of rosacea with ivermectin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Treatment of papulopustular rosacea with ivermectin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Treatment of papulopustular rosacea with ivermectin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 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 | ⤷ Sign Up | ⤷ Sign Up |
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Japan | 6438466 | ⤷ Sign Up | |
| Brazil | PI0410503 | uso da ivermectina para a fabricação de uma composição farmacêutica tópica, composição tópica e uso da composição | ⤷ Sign Up |
| Chile | 2016000009 | Tratamiento de rosacea papulopustular con ivermectina. | ⤷ Sign Up |
| Poland | 378932 | Zastosowanie ivermectiny do leczenia schorzeń dermatologicznych (TOPICAL FORMULATION OF IVERMECTIN FOR THE TREATMENT OF DERMATOLOGICAL CONDITIONS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SOOLANTRA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1620113 | C 2015 036 | Romania | ⤷ Sign Up | 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 | CR 2015 00045 | Denmark | ⤷ Sign Up | PRODUCT NAME: LVERMECTIN (22,23-DIHYDROAVERMECTIN B1 A + 22,23-DIHYDROAVERMECTIN B1 B); NAT. REG. NO/DATE: 54123 20150422; FIRST REG. NO/DATE: MT MA 117/01101 20150402 |
| 1620113 | C300756 | Netherlands | ⤷ Sign Up | PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MA117/01101 20150402 |
| 1620113 | PA2015033,C1620113 | Lithuania | ⤷ Sign Up | PRODUCT NAME: IVERMEKTINAS; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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