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Imiquimod Patent Expiration

Imiquimod is Used for treating skin conditions caused by certain types of viruses. It was first introduced by Bausch Health Us Llc in its drug Aldara on Feb 27, 1997. Another drug containing Imiquimod is Zyclara. 9 different companies have introduced drugs containing Imiquimod.


Imiquimod Patents

Given below is the list of patents protecting Imiquimod, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Zyclara US10918635 Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts Apr 30, 2030 Bausch
Zyclara US11202752 Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy Apr 30, 2030 Bausch
Zyclara US11850245 Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts Apr 30, 2030 Bausch
Zyclara US10238644 2×2×2 week dosing regimen for treating acting keratosis with pharmaceutical compositions formulated with 3.75% imiquimod Dec 11, 2029 Bausch
Zyclara US11318130 2x2x2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75% imiquimod Dec 11, 2029 Bausch
Zyclara US8222270 2×2×2 week treatment regimen for treating actinic keratosis with pharmaceutical compositions formulated with 2.5% imiquimod Dec 11, 2029 Bausch
Zyclara US8236816 2×2×2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75 % imiquimod Dec 11, 2029 Bausch
Zyclara US8299109 Method of treating actinic keratosis with 3.75% imiquimod cream Dec 11, 2029 Bausch
Zyclara US10238645 Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts Aug 18, 2029 Bausch
Zyclara US8598196 Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy Aug 18, 2029 Bausch
Aldara US7696159

(Pediatric)

 Treatment for basal cell carcinoma Oct 01, 2024

(Expired)

 Bausch
Aldara US7696159 Treatment for basal cell carcinoma Apr 01, 2024

(Expired)

 Bausch



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Imiquimod's patents.

Given below is the list recent legal activities going on the following patents of Imiquimod.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 20 Mar, 2024 US8299109(Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 23 Jan, 2024 US8236816(Litigated)
Patent Issue Date Used in PTA Calculation
Critical
 26 Dec, 2023 US11850245
Recordation of Patent Grant Mailed
Critical
 26 Dec, 2023 US11850245
Mail Patent eGrant Notification 26 Dec, 2023 US11850245
Email Notification
Critical
 26 Dec, 2023 US11850245
Recordation of Patent eGrant 26 Dec, 2023 US11850245
Patent eGrant Notification 26 Dec, 2023 US11850245
Payment of Maintenance Fee, 12th Year, Large Entity 19 Dec, 2023 US8222270
Email Notification
Critical
 07 Dec, 2023 US11850245


Imiquimod's Family Patents

Family Patents

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Imiquimod Generic API Manufacturers

Several generic applications have been filed for Imiquimod. The first generic version for Imiquimod was by Fougera Pharmaceuticals Inc and was approved on Feb 25, 2010. And the latest generic version is by Taro Pharmaceutical Industries Ltd and was approved on Jan 26, 2021.

Given below is the list of companies who have filed for Imiquimod generic, along with the locations of their manufacturing plants worldwide.


1. APOTEX INC

Apotex Inc has filed for 1 generic for Imiquimod. Given below are the details of the strengths of this generic introduced by Apotex Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5%

cream Discontinued TOPICAL N/A Apr 6, 2012


Manufacturing Plant Locations
New

Apotex Inc's manufacturing plants are situated in 1 country - Canada. Given below are the details of these plant locations as well as the firm names of Apotex Inc as present at those locations.

Country City Firm Name
Canada
Richmond Hill Apotex Inc.
North York Apotex Inc.
Toronto Apotex Inc.





2. COSETTE

Cosette Pharmaceuticals Inc has filed for 1 generic for Imiquimod. Given below are the details of the strengths of this generic introduced by Cosette.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5%

cream Discontinued TOPICAL N/A Apr 18, 2011


Manufacturing Plant Locations
New

Cosette's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Cosette as present at those locations.

Country City Firm Name
United States
Lincolnton Cosette Pharmaceuticals NC Laboratories, LLC
South Plainfield Cosette Pharmaceuticals, Inc.





3. ENCUBE

Encube Ethicals Private Ltd has filed for 1 generic for Imiquimod. Given below are the details of the strengths of this generic introduced by Encube.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5%

cream Discontinued TOPICAL N/A Feb 28, 2011


Manufacturing Plant Locations
New

Encube's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Encube as present at those locations.

Country City Firm Name
India
Ponda Encube Ethicals Pvt. Ltd.
Andheri East, Mumbai Encube Ethicals Private Ltd





4. FOUGERA PHARMS

Fougera Pharmaceuticals Inc has filed for 1 generic for Imiquimod. Given below are the details of the strengths of this generic introduced by Fougera Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5%

cream Prescription TOPICAL AB Feb 25, 2010





5. GLENMARK PHARMS INC

Glenmark Pharmaceuticals Inc Usa has filed for 1 generic for Imiquimod. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5%

(reference standard)

cream Prescription TOPICAL AB Mar 6, 2012





6. PADAGIS ISRAEL

Padagis Israel Pharmaceuticals Ltd has filed for 1 generic for Imiquimod. Given below are the details of the strengths of this generic introduced by Padagis Israel.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5%

cream Prescription TOPICAL AB Sep 7, 2010


Manufacturing Plant Locations
New

Padagis Israel's manufacturing plants are situated in 1 country - Israel. Given below are the details of these plant locations as well as the firm names of Padagis Israel as present at those locations.

Country City Firm Name
Israel
Yerucham Padagis Israel Pharmaceuticals Ltd.





7. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 1 generic for Imiquimod. Given below are the details of the strengths of this generic introduced by Strides Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5%

cream Discontinued TOPICAL N/A Jun 24, 2014


Manufacturing Plant Locations
New

Strides Pharma's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Strides Pharma as present at those locations.

Country City Firm Name
United States
Chestnut Ridge Strides Pharma, Inc.
East Brunswick Strides Pharma Inc.
India
Bangalore Strides Pharma Science Limited
Puducherry Strides Pharma Science Limited





8. TARO

Taro Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Imiquimod. Given below are the details of the strengths of this generic introduced by Taro.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5%

cream Prescription TOPICAL AB Apr 15, 2011
3.75%

cream Prescription TOPICAL AB Jan 26, 2021


Manufacturing Plant Locations
New

Taro's manufacturing plants are situated in 3 countries - United States, Israel, Canada. Given below are the details of these plant locations as well as the firm names of Taro as present at those locations.

Country City Firm Name
United States
Honolulu Taro Delight, LLC
Hawthorne Taro Pharmaceuticals U.S.A., Inc.
Israel
Haifa Taro Pharmaceutical Industries, Ltd.
Canada
Brampton Taro Pharmaceuticals Inc.