NATROBA Drug Patent Profile
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When do Natroba patents expire, and what generic alternatives are available?
Natroba is a drug marketed by Parapro Llc and is included in one NDA. There are two patents protecting this drug.
This drug has thirty-seven patent family members in twenty-eight countries.
The generic ingredient in NATROBA is spinosad. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the spinosad profile page.
DrugPatentWatch® Generic Entry Outlook for Natroba
Natroba was eligible for patent challenges on January 18, 2015.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 28, 2024. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for NATROBA
| International Patents: | 37 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 4 |
| Patent Applications: | 4,016 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for NATROBA |
| What excipients (inactive ingredients) are in NATROBA? | NATROBA excipients list |
| DailyMed Link: | NATROBA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for NATROBA
Generic Entry Date for NATROBA*:
Constraining patent/regulatory exclusivity:
FOR THE TOPICAL TREATMENT OF SCABIES INFESTATIONS IN ADULT AND PEDIATRIC PATIENTS 4 YEARS OF AGE AND OLDER NDA:
Dosage:
SUSPENSION;TOPICAL |
*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 NATROBA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| MicroConstants, Inc. | Phase 4 |
| Concentrics Research | Phase 4 |
| Medpace, Inc. | Phase 4 |
Pharmacology for NATROBA
| Drug Class | Pediculicide |
US Patents and Regulatory Information for NATROBA
NATROBA is protected by two US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of NATROBA is ⤷ Try a Trial.
This potential generic entry date is based on FOR THE TOPICAL TREATMENT OF SCABIES INFESTATIONS IN ADULT AND PEDIATRIC PATIENTS 4 YEARS OF AGE AND OLDER.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting NATROBA
Formulations for controlling human lice
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: NATROBA TOPICAL SUSPENSION IS A PEDICULICIDE INDICATED FOR THE TOPICAL TREATMENT OF HEAD LICE INFESTATION IN PATIENTS SIX (6) MONTHS OF AGE AND OLDER.
Methods and compositions useful for controlling cutaneous mites
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: THE PRODUCT COMPOSITION (NATROBA) IS FOR THE TOPICAL TREATMENT OF HUMAN SCABIES MITE INFESTATIONS BY MELTING AND DELIVERING THE ACTIVE INGREDIENT, SPINOSAD, TO THE STRATUM CORNEUM WHERE SCABIES MITES LIVE AND BREED
FDA Regulatory Exclusivity protecting NATROBA
FOR THE TOPICAL TREATMENT OF SCABIES INFESTATIONS IN ADULT AND PEDIATRIC PATIENTS 4 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Parapro Llc | NATROBA | spinosad | SUSPENSION;TOPICAL | 022408-001 | Jan 18, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Parapro Llc | NATROBA | spinosad | SUSPENSION;TOPICAL | 022408-001 | Jan 18, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Parapro Llc | NATROBA | spinosad | SUSPENSION;TOPICAL | 022408-001 | Jan 18, 2011 | 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 NATROBA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Parapro Llc | NATROBA | spinosad | SUSPENSION;TOPICAL | 022408-001 | Jan 18, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Parapro Llc | NATROBA | spinosad | SUSPENSION;TOPICAL | 022408-001 | Jan 18, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Parapro Llc | NATROBA | spinosad | SUSPENSION;TOPICAL | 022408-001 | Jan 18, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Parapro Llc | NATROBA | spinosad | SUSPENSION;TOPICAL | 022408-001 | Jan 18, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for NATROBA
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Elanco GmbH | Comfortis | spinosad | EMEA/V/C/002233 Treatment and prevention of flea infestations (Ctenocephalides felis).The preventive effect against re-infestations is a result of the adulticidal activity and the reduction in egg production and persists for up to 4 weeks after a single administration of the product.The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD). |
Withdrawn | no | no | no | 2011-02-11 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for NATROBA
See the table below for patents covering NATROBA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Africa | 200007322 | Formulations for controlling human lice. | ⤷ Try a Trial |
| Australia | 750046 | ⤷ Try a Trial | |
| Japan | 2002519365 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 9106552 | ⤷ Try a Trial | |
| Spain | 2260391 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NATROBA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0375316 | C350009 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: SPINOSAD, DESGEWENST IN DE VORM VAN EEN ZOUT; NATL. REGISTRATION NO/DATE: 12363 N 20020913; FIRST REGISTRATION: SE 4511 20020204 |
| 0375316 | SPC/GB02/028 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: SPINOSAD; REGISTERED: CH W 6020 20010313; UK 0714 20020227 |
| 0375316 | 350009 | Netherlands | ⤷ Try a Trial | |
| 0375316 | 06C0047 | France | ⤷ Try a Trial | PRODUCT NAME: SPINOSAD; REGISTRATION NO/DATE IN FRANCE: 2060098 DU 20060628; REGISTRATION NO/DATE AT EEC: 9275/B DU 20011023 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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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