Generic Sofdra Availability

Last updated on Apr 10, 2025.

Sofdra is a brand name of sofpironium topical, approved by the FDA in the following formulation(s):

SOFDRA (sofpironium bromide - gel, metered;topical)

Manufacturer: BOTANIX SB
Approval date: June 18, 2024
Strength(s): EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) ^[RLD]

Is there a generic version of Sofdra available?

No. There is currently no therapeutically equivalent version of Sofdra available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Sofdra. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Method of dosing and use of soft anticholinergic esters
Patent 10,383,846
Issued: August 20, 2019
Inventor(s): Bodor; Nicholas S. et al.
Assignee(s): BODOR LABORATORIES, INC. (Miami, FL)
The subject application is directed to a method of treating hyperhidrosis in a mammalian subject comprising topically administering a composition comprising a pharmaceutically acceptable vehicle and from about 1.0% to about 25% of a compound selected from the group consisting of: (i) 3-(2-cyclopentyl-2-phenyl-2-hydroxyacetoxy)-1-(methoxycarbonylmethyl)-1-methylpyrrolidinium bromide; and (ii) 3-(2-cyclopentyl-2-phenyl-2-hydroxyacetoxy)-1-(ethoxycarbonylmethyl)-1-methylpyrrolidinium bromide; to skin of an area of a mammalian subject suffering from hyperhidosis, before bedtime, such that, compared to untreated, baseline conditions, sweat production is reduced by at least about 25% for at least about six (6) hours; and such that sweat production is reduced by an amount substantially equivalent to an amount that sweat production is reduced as compared to untreated, baseline conditions, following administration of a composition comprising the same concentration of glycopyrrolate.
Patent expiration dates:
- March 14, 2034
  ✓
  Patent use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
Formulation for soft anticholinergic analogs
Patent 10,947,192
Issued: March 16, 2021
Inventor(s): Bodor; Nicholas S. et al.
Assignee(s): BODOR LABORATORIES, INC. (Miami, FL)
Topical formulations comprising soft glycopyrrolates are useful for treating excessive sweating conditions in subjects, such as humans suffering from hyperhidrosis. Preferably, at least one soft anticholinergic agent is provided in an effective amount or concentration in an anhydrous formulation that can inhibit excessive perspiration resulting from a condition such as hyperhidrosis.
Patent expiration dates:
- May 22, 2034
  ✓
  Patent use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
Formulation for soft anticholinergic analogs
Patent 10,952,990
Issued: March 23, 2021
Inventor(s): Bodor; Nicholas S. et al.
Assignee(s): BODOR LABORATORIES, INC. (Miami, FL)
Topical formulations comprising soft glycopyrrolates are useful for treating excessive sweating conditions in subjects, such as humans suffering from hyperhidrosis. Preferably, at least one soft anticholinergic agent is provided in an effective amount or concentration in an anhydrous formulation that can inhibit excessive perspiration resulting from a condition such as hyperhidrosis.
Patent expiration dates:
- May 22, 2034
  ✓
  Patent use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
Formulation for soft anticholinergic analogs
Patent 10,959,983
Issued: March 30, 2021
Inventor(s): Bodor; Nicholas S. et al.
Assignee(s): BODOR LABORATORIES, INC. (Miami, FL)
Topical formulations comprising soft glycopyrrolates are useful for treating excessive sweating conditions in subjects, such as humans suffering from hyperhidrosis. Preferably, at least one soft anticholinergic agent is provided in an effective amount or concentration in an anhydrous formulation that can inhibit excessive perspiration resulting from a condition such as hyperhidrosis.
Patent expiration dates:
- May 22, 2034
  ✓
  Patent use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
Formulation for soft anticholinergic analogs
Patent 10,961,191
Issued: March 30, 2021
Inventor(s): Bodor; Nicholas S. et al.
Assignee(s): BODOR LABORATORIES, INC. (Miami, FL)
Topical formulations comprising soft glycopyrrolates are useful for treating excessive sweating conditions in subjects, such as humans suffering from hyperhidrosis. Preferably, at least one soft anticholinergic agent is provided in an effective amount or concentration in an anhydrous formulation that can inhibit excessive perspiration resulting from a condition such as hyperhidrosis.
Patent expiration dates:
- May 22, 2034
  ✓
  Patent use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
Formulation for soft anticholinergic analogs
Patent 11,026,919
Issued: June 8, 2021
Inventor(s): Bodor; Nicholas S. et al.
Assignee(s): BODOR LABORATORIES, INC. (Miami, FL)
Topical formulations comprising soft glycopyrrolates are useful for treating excessive sweating conditions in subjects, such as humans suffering from hyperhidrosis. Preferably, at least one soft anticholinergic agent is provided in an effective amount or concentration in an anhydrous formulation that can inhibit excessive perspiration resulting from a condition such as hyperhidrosis.
Patent expiration dates:
- May 22, 2034
  ✓
  Patent use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
  ✓
  Drug product
Formulation for soft anticholinergic analogs
Patent 11,034,652
Issued: June 15, 2021
Inventor(s): Bodor; Nicholas S. et al.
Assignee(s): BODOR LABORATORIES, INC. (Miami, FL)
Topical formulations comprising soft glycopyrrolates are useful for treating excessive sweating conditions in subjects, such as humans suffering from hyperhidrosis. Preferably, at least one soft anticholinergic agent is provided in an effective amount or concentration in an anhydrous formulation that can inhibit excessive perspiration resulting from a condition such as hyperhidrosis.
Patent expiration dates:
- May 22, 2034
  ✓
  Patent use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
  ✓
  Drug product
Formulation for soft anticholinergic analogs
Patent 11,052,067
Issued: July 6, 2021
Inventor(s): Bodor; Nicholas S. et al.
Assignee(s): Bodor Laboratories, Inc. (Miami, FL)
Topical formulations comprising soft glycopyrrolates are useful for treating excessive sweating conditions in subjects, such as humans suffering from hyperhidrosis. Preferably, at least one soft anticholinergic agent is provided in an effective amount or concentration in an anhydrous formulation that can inhibit excessive perspiration resulting from a condition such as hyperhidrosis.
Patent expiration dates:
- May 22, 2034
  ✓
  Patent use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
  ✓
  Drug product
Formulation for soft anticholinergic analogs
Patent 11,084,788
Issued: August 10, 2021
Inventor(s): Bodor; Nicholas S. et al.
Assignee(s): BODOR LABORATORIES, INC. (Miami, FL)
Topical formulations comprising soft glycopyrrolates are useful for treating excessive sweating conditions in subjects, such as humans suffering from hyperhidrosis. Preferably, at least one soft anticholinergic agent is provided in an effective amount or concentration in an anhydrous formulation that can inhibit excessive perspiration resulting from a condition such as hyperhidrosis.
Patent expiration dates:
- May 22, 2034
  ✓
  Patent use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
  ✓
  Drug product
Formulation for soft anticholinergic analogs
Patent 11,123,325
Issued: September 21, 2021
Inventor(s): Bodor; Nicholas S. et al.
Assignee(s): BODOR LABORATORIES, INC. (Miami, FL)
Topical formulations comprising soft glycopyrrolates are useful for treating excessive sweating conditions in subjects, such as humans suffering from hyperhidrosis. Preferably, at least one soft anticholinergic agent is provided in an effective amount or concentration in an anhydrous formulation that can inhibit excessive perspiration resulting from a condition such as hyperhidrosis.
Patent expiration dates:
- July 20, 2037
  ✓
  Patent use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
  ✓
  Drug product
Crystalline form of sofpironium bromide and preparation method thereof
Patent 11,566,000
Issued: January 31, 2023
Inventor(s): Marubayashi; Kazuyoshi et al.
Assignee(s): Botanix SB, Inc. (King of Prussia, PA)
A cocrystal containing the 1′R-diastereomer and the 1'S-diastereomer of sofpironium bromide at a ratio of 1:3 (Form CO), a crystal mixture (for example, Form B) containing Form CO and a crystalline form of the 1′R-diastereomer (Form MN), and a method for preparing sofpironium bromide, which is suitable for manufacture of the crystal mixture are provided. Form CO and a crystalline form of sofpironium bromide containing Form CO (for example, Form B) have superior stability without hygroscopic property, and accordingly they can be preferably used as a raw material of medicaments.
Patent expiration dates:
- May 22, 2040
  ✓
  Drug substance
  ✓
  Drug product
Crystalline form of sofpironium bromide and preparation method thereof
Patent 11,584,715
Issued: February 21, 2023
Inventor(s): Marubayashi; Kazuyoshi et al.
Assignee(s): Botanix SB, Inc. (King of Prussia, PA)
A cocrystal containing the 1′R-diastereomer and the 1′S-diastereomer of sofpironium bromide at a ratio of 1:3 (Form CO), a crystal mixture (for example, Form B) containing Form CO and a crystalline form of the 1′R-diastereomer (Form MN), and a method for preparing sofpironium bromide, which is suitable for manufacture of the crystal mixture are provided. Form CO and a crystalline form of sofpironium bromide containing Form CO (for example, Form B) have superior stability without hygroscopic property, and accordingly they can be preferably used as a raw material of medicaments.
Patent expiration dates:
- May 22, 2040
  ✓
  Drug substance
  ✓
  Drug product
Soft anticholinergic esters
Patent 8,147,809
Issued: April 3, 2012
Inventor(s): Bodor; Nicholas S.
Soft anticholinergic esters of the formulas: ##STR00001## wherein R.sub.1 and R.sub.2 are both phenyl or one of R.sub.1 and R.sub.2 is phenyl and the other is cyclopentyl; R is C.sub.1-C.sub.8 alkyl, straight or branched chain; and X.sup.- is an anion with a single negative charge; and wherein each asterisk marks a chiral center; said compound having the R, S or RS stereoisomeric configuration at each chiral center unless specified otherwise, or being a mixture thereof.
Patent expiration dates:
- March 26, 2027
  ✓
  Drug substance
  ✓
  Drug product
Soft anticholinergic esters
Patent 8,628,759
Issued: January 14, 2014
Inventor(s): Bodor; Nicholas S.
Assignee(s): Bodor Laboratories, Inc. (Miami, FL)
Soft anticholinergic esters of the formulas: ##STR00001## wherein R.sub.1 and R.sub.2 are both phenyl or one of R.sub.1 and R.sub.2 is phenyl and the other is cyclopentyl; R is C.sub.1-C.sub.8 alkyl, straight or branched chain; and X.sup.- is an anion with a single negative charge; and wherein each asterisk marks a chiral center; said compound having the R, S or RS stereoisomeric configuration at each chiral center unless specified otherwise, or being a mixture thereof.
Patent expiration dates:
- November 13, 2026
  ✓
  Patent use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
Method of dosing and use of soft anticholinergic esters
Patent 9,220,707
Issued: December 29, 2015
Inventor(s): Bodor; Nicholas S. et al.
Assignee(s): BODOR LABORATORIES, INC. (Miami, FL)
A method of treating hyperhidrosis in a mammalian subject comprising: a) providing a composition comprising a pharmaceutically acceptable vehicle and from about 1.0% to about 25% of a compound having the formula: ##STR00001##
and b) topically administering the composition to skin of an area of a mammalian subject suffering from hyperhidosis, before bedtime, such that, compared to untreated, baseline conditions, sweat production is reduced by at least about 25% for at least about six (6) hours.
Patent expiration dates:
- March 14, 2034
  ✓
  Patent use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
Method of dosing and use of soft anticholinergic esters
Patent 9,492,429
Issued: November 15, 2016
Inventor(s): Bodor; Nicholas S. et al.
Assignee(s): BODOR LABORATORIES, INC. (Miami, FL)
A method of treating hyperhidrosis in a mammalian subject comprising: a) providing a composition comprising a pharmaceutically acceptable vehicle and from about 1.0% to about 25% of a compound having the formula: ##STR00001##
and b) topically administering the composition to skin of an area of a mammalian subject suffering from hyperhidosis, before bedtime, such that, compared to untreated, baseline conditions, sweat production is reduced by at least about 25% for at least about six (6) hours.
Patent expiration dates:
- March 14, 2034
  ✓
  Patent use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
  ✓
  Drug product
Method of dosing and use of soft anticholinergic esters
Patent 9,895,350
Issued: February 20, 2018
Inventor(s): Bodor; Nicholas S. et al.
Assignee(s): BODOR LABORATORIES, INC. (Miami, FL)
A method of treating hyperhidrosis in a mammalian subject including: a) providing a composition including a pharmaceutically acceptable vehicle and from about 1.0% to about 25% of a compound having the formula: ##STR00001##
and b) topically administering the composition to skin of an area of a mammalian subject suffering from hyperhidosis, before bedtime, such that, compared to untreated, baseline conditions, sweat production is reduced by at least about 25% for at least about six (6) hours.
Patent expiration dates:
- March 14, 2034
  ✓
  Patent use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:
- June 20, 2029 - NEW CHEMICAL ENTITY

More about Sofdra (sofpironium topical)

Patient resources

Sofdra drug information

Professional resources

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Hyperhidrosis

Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

User Reviews & Ratings

9.8 / 10

42 Reviews

Images

Pill medicine is Sofdra 12.45% topical gel — Sofdra 12.45% topical gel