Tavaborole - Generic Drug Details
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What are the generic drug sources for tavaborole and what is the scope of freedom to operate?
Tavaborole
is the generic ingredient in two branded drugs marketed by Anacor Pharms Inc, Aleor Dermaceuticals, Amneal, Chartwell Rx, Cipla, Encube, Lupin Ltd, Padagis Us, and Taro Pharms, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.There are six drug master file entries for tavaborole. Ten suppliers are listed for this compound.
Summary for tavaborole
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 9 |
| NDAs: | 9 |
| Drug Master File Entries: | 6 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 90 |
| Clinical Trials: | 1 |
| Patent Applications: | 445 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tavaborole |
| What excipients (inactive ingredients) are in tavaborole? | tavaborole excipients list |
| DailyMed Link: | tavaborole at DailyMed |
Recent Clinical Trials for tavaborole
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pfizer | Phase 4 |
Pharmacology for tavaborole
| Drug Class | Oxaborole Antifungal |
| Mechanism of Action | Protein Synthesis Inhibitors |
Paragraph IV (Patent) Challenges for TAVABOROLE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| KERYDIN | Topical Solution | tavaborole | 5% | 204427 | 13 | 2018-07-09 |
US Patents and Regulatory Information for tavaborole
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lupin Ltd | TAVABOROLE | tavaborole | SOLUTION;TOPICAL | 212168-001 | Feb 8, 2021 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Taro Pharms | TAVABOROLE | tavaborole | SOLUTION;TOPICAL | 212215-001 | May 7, 2021 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Cipla | TAVABOROLE | tavaborole | SOLUTION;TOPICAL | 212224-001 | Feb 9, 2021 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Chartwell Rx | TAVABOROLE | tavaborole | SOLUTION;TOPICAL | 211963-001 | Feb 3, 2021 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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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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