Sofdra is a drug owned by Botanix Sb Inc. It is protected by 3 US drug patents filed in 2024 out of which none have expired yet. Sofdra's patents will be open to challenges from 20 June, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be May 22, 2040. Details of Sofdra's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US11584715 | Crystalline form of sofpironium bromide and preparation method thereof |
May, 2040
(15 years from now) | Active |
| US11566000 | Crystalline form of sofpironium bromide and preparation method thereof |
May, 2040
(15 years from now) | Active |
| US8147809 | Soft anticholinergic esters |
Mar, 2027
(2 years from now) | Active |
FDA has granted several exclusivities to Sofdra. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Sofdra, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Sofdra.
Exclusivity Information
Sofdra holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Sofdra's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 20, 2029 |
US patents provide insights into the exclusivity only within the United States, but Sofdra is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Sofdra's family patents as well as insights into ongoing legal events on those patents.
Sofdra's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Sofdra's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 22, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sofdra Generics:
There are no approved generic versions for Sofdra as of now.
About Sofdra
Sofdra is a drug owned by Botanix Sb Inc. Sofdra uses Sofpironium Bromide as an active ingredient. Sofdra was launched by Botanix Sb in 2024.
Approval Date:
Sofdra was approved by FDA for market use on 18 June, 2024.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Sofdra is 18 June, 2024, its NCE-1 date is estimated to be 20 June, 2028.
Active Ingredient:
Sofdra uses Sofpironium Bromide as the active ingredient. Check out other Drugs and Companies using Sofpironium Bromide ingredient
Dosage:
Sofdra is available in gel, metered form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) | GEL, METERED | Prescription | TOPICAL |