Berdazimer sodium - Generic Drug Details
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What are the generic drug sources for berdazimer sodium and what is the scope of freedom to operate?
Berdazimer sodium
is the generic ingredient in one branded drug marketed by Lnhc and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Berdazimer sodium has fifty-eight patent family members in nine countries.
Summary for berdazimer sodium
| International Patents: | 58 |
| US Patents: | 14 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 2 |
| DailyMed Link: | berdazimer sodium at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for berdazimer sodium
Generic Entry Date for berdazimer sodium*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
GEL;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 berdazimer sodium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Synteract, Inc. | Phase 3 |
| Novan, Inc. | Phase 3 |
US Patents and Regulatory Information for berdazimer sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lnhc | ZELSUVMI | berdazimer sodium | GEL;TOPICAL | 217424-001 | Jan 5, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Lnhc | ZELSUVMI | berdazimer sodium | GEL;TOPICAL | 217424-001 | Jan 5, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Lnhc | ZELSUVMI | berdazimer sodium | GEL;TOPICAL | 217424-001 | Jan 5, 2024 | 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 |
International Patents for berdazimer sodium
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2013006859 | NITRIC OXIDE-RELEASING PARTICLE FOR NITRIC OXIDE THERAPEUTICS AND BIOMEDICAL APPLICATION | ⤷ Sign Up |
| Canada | 3062005 | GELS TOPIQUES (TOPICAL GELS) | ⤷ Sign Up |
| Japan | 2022163171 | 局所用組成物及びこれを使用する方法 | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
