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NATROBA Drug Profile
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» See Plans and PricingWhen 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 forty-eight patent family members in thirty 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.
US ANDA Litigation and 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 July 2, 2021. This may change due to patent challenges or generic licensing.
Annual sales in 2017 were $2mm indicating the motivation for generic entry.
Indicators of Generic Entry
Summary for NATROBA
| International Patents: | 48 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 3 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for NATROBA |
| Drug Sales Revenues: | Drug sales revenues for NATROBA |
| DailyMed Link: | NATROBA at DailyMed |
Generic Entry Opportunity Date for NATROBA
Generic Entry Date for NATROBA*:
Constraining patent/regulatory exclusivity:
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 |
|---|---|
| Accelovance | Phase 3 |
| ParaPRO LLC | Phase 3 |
| ParaPRO LLC | Phase 4 |
Pharmacology for NATROBA
| Drug Class | Pediculicide |
Synonyms for NATROBA
| Comfortis |
| EC 434-300-1 |
| NaturaLyte |
| Spinosad [USAN] |
| UNII-XPA88EAP6V |
| XDE 105 |
| XPA88EAP6V |
US Patents and Regulatory Information for NATROBA
| 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 | Start Trial | Start Trial | Y | Start Trial | |||
| Parapro Llc | NATROBA | spinosad | SUSPENSION;TOPICAL | 022408-001 | Jan 18, 2011 | 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 NATROBA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Parapro Llc | NATROBA | spinosad | SUSPENSION;TOPICAL | 022408-001 | Jan 18, 2011 | Start Trial | Start Trial |
| Parapro Llc | NATROBA | spinosad | SUSPENSION;TOPICAL | 022408-001 | Jan 18, 2011 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NATROBA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2382806 | Start Trial |
| Germany | 122007000053 | Start Trial |
| Turkey | 200003818 | Start Trial |
| Brazil | 8906547 | Start Trial |
| Hungary | T52562 | Start Trial |
| Netherlands | 350009 | Start Trial |
| Japan | 2010229147 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for NATROBA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0375316 | C350009 | Netherlands | Start Trial | PRODUCT NAME: SPINOSAD, DESGEWENST IN DE VORM VAN EEN ZOUT; NATL. REGISTRATION NO/DATE: 12363 N 20020913; FIRST REGISTRATION: SE 4511 20020204 |
| 0375316 | 350009 | Netherlands | Start Trial | |
| 0375316 | 06C0047 | France | Start Trial | PRODUCT NAME: SPINOSAD; REGISTRATION NO/DATE IN FRANCE: 2060098 DU 20060628; REGISTRATION NO/DATE AT EEC: 9275/B DU 20011023 |
| 0375316 | SPC/GB02/028 | United Kingdom | Start Trial | PRODUCT NAME: SPINOSAD; REGISTERED: CH W 6020 20010313; UK 0714 20020227 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
