natroba Drug Patent Profile
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Which patents cover Natroba, and when can generic versions of Natroba launch?
Natroba is a drug marketed by Cipher and is included in one NDA. There is one patent protecting this drug.
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.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for natroba?
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Summary for natroba
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 4 |
| Patent Applications: | 3,493 |
| Drug Prices: | Drug price information for natroba |
| Drug Sales Revenues: | Drug sales revenues for natroba |
| What excipients (inactive ingredients) are in natroba? | natroba excipients list |
| DailyMed Link: | natroba at DailyMed |
Recent Clinical Trials for natroba
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Concentrics Research | Phase 4 |
| Medpace, Inc. | Phase 4 |
| STATKING Clinical Services | Phase 4 |
Pharmacology for natroba
| Drug Class | Pediculicide |
US Patents and Regulatory Information for natroba
natroba is protected by one US patents and one FDA Regulatory Exclusivity.
Patents protecting natroba
Methods and compositions useful for controlling cutaneous mites
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cipher | NATROBA | spinosad | SUSPENSION;TOPICAL | 022408-001 | Jan 18, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Cipher | NATROBA | spinosad | SUSPENSION;TOPICAL | 022408-001 | Jan 18, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 natroba
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cipher | NATROBA | spinosad | SUSPENSION;TOPICAL | 022408-001 | Jan 18, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Cipher | NATROBA | spinosad | SUSPENSION;TOPICAL | 022408-001 | Jan 18, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Cipher | NATROBA | spinosad | SUSPENSION;TOPICAL | 022408-001 | Jan 18, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Cipher | NATROBA | spinosad | SUSPENSION;TOPICAL | 022408-001 | Jan 18, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Australia | 631693 | ⤷ Sign Up | |
| Portugal | 968706 | ⤷ Sign Up | |
| Germany | 68920301 | ⤷ Sign Up | |
| Hungary | 228990 | FORMULATIONS FOR CONTROLLING HUMAN LICE | ⤷ Sign Up |
| Taiwan | I228994 | ⤷ Sign Up | |
| Brazil | 8906547 | ⤷ Sign Up | |
| China | 1129430 | ⤷ Sign Up | |
| >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 | ⤷ Sign Up | PRODUCT NAME: SPINOSAD, DESGEWENST IN DE VORM VAN EEN ZOUT; NATL. REGISTRATION NO/DATE: 12363 N 20020913; FIRST REGISTRATION: SE 4511 20020204 |
| 0375316 | 06C0047 | France | ⤷ Sign Up | 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 | ⤷ Sign Up | PRODUCT NAME: SPINOSAD; REGISTERED: CH W 6020 20010313; UK 0714 20020227 |
| 0375316 | 350009 | Netherlands | ⤷ Sign Up | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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