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Miconazole Nitrate Patent Expiration

Miconazole Nitrate was first introduced by Insight Pharmaceuticals Corp in its drug Monistat-Derm on Approved Prior to Jan 1, 1982. Other drugs containing Miconazole Nitrate are Monistat 3, Monistat 3 Combination Pack, Monistat 1 Combination Pack, Monistat 7, Monistat 3 Combination Pack (Prefilled), Monistat 7 Combination Pack, Monistat 5. 13 different companies have introduced drugs containing Miconazole Nitrate.


Miconazole Nitrate Patents

Given below is the list of patents protecting Miconazole Nitrate, 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
Monistat 1 Combination Pack US6153635 Methods and kits for treating vulvovaginal candidiasis with miconazole nitrate Nov 28, 2020

(Expired)

 Medtech Products
Monistat 1 Combination Pack US5514698 Antifungal vaginal cream composition Mar 21, 2014

(Expired)

 Medtech Products



Miconazole Nitrate's Family Patents

Family Patents

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Miconazole Nitrate Generic API Manufacturers

Several generic applications have been filed for Miconazole Nitrate. The first generic version for Miconazole Nitrate was by Teva Pharmaceuticals Usa and was approved on Oct 30, 1992. And the latest generic version is by Perrigo R And D Co and was approved on Jun 2, 2010.

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


1. ACTAVIS MID ATLANTIC

Actavis Mid Atlantic Llc has filed for 1 generic for Miconazole Nitrate. This 2%,100mg version comes by the name M-ZOLE 7 DUAL PACK. Given below are the details of the strengths of this generic introduced by Actavis Mid Atlantic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2%,100MG

cream, suppository Discontinued TOPICAL, VAGINAL N/A Jul 17, 1997





2. ACTAVIS PHARMA

Actavis Pharma Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 1 generic for Miconazole Nitrate. Given below are the details of the strengths of this generic introduced by Actavis Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

suppository Prescription VAGINAL AB Nov 19, 1993


Manufacturing Plant Locations
New

Actavis Pharma'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 Actavis Pharma as present at those locations.

Country City Firm Name
India
Chennai Actavis Pharma Development Centre Private Ltd





3. COSETTE

Cosette Pharmaceuticals Inc has filed for 4 different strengths of generic version for Miconazole Nitrate. Out of these 2%,200mg version comes by the name M-ZOLE 3 COMBINATION PACK, 2%,100mg version comes by the name MICONAZOLE 7 COMBINATION PACK. Given below are the details of the strengths of this generic introduced by Cosette.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG

suppository Discontinued VAGINAL N/A Apr 30, 1997
2%

cream Discontinued VAGINAL N/A Feb 22, 1996
2%,200MG

cream, suppository Over the counter TOPICAL, VAGINAL N/A Apr 16, 1999
2%,100MG

cream, suppository Discontinued TOPICAL, VAGINAL N/A Mar 26, 2004


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
South Plainfield Cosette Pharmaceuticals, Inc.
Lincolnton Cosette Pharmaceuticals NC Laboratories, LLC





4. L PERRIGO CO

L Perrigo Co has filed for 1 generic for Miconazole Nitrate. This 2%,200mg version comes by the name MICONAZOLE NITRATE COMBINATION PACK. Given below are the details of the strengths of this generic introduced by L Perrigo Co.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2%,200MG

cream, suppository Over the counter TOPICAL, VAGINAL N/A Apr 20, 1999





5. P AND L

P And L Development Llc has filed for 1 generic for Miconazole Nitrate. This 2% version comes by the name MICONAZOLE 7. Given below are the details of the strengths of this generic introduced by P And L.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2%

cream Over the counter VAGINAL N/A Mar 29, 1996





6. PERRIGO

L Perrigo Co has filed for 3 different strengths of generic version for Miconazole Nitrate. Out of these 2%,4% version comes by the name MICONAZOLE 3 COMBINATION PACK. Given below are the details of the strengths of this generic introduced by Perrigo.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG

suppository Discontinued VAGINAL N/A Mar 20, 1997
2%

cream Over the counter VAGINAL N/A May 15, 1997
2%,4%

cream Over the counter TOPICAL, VAGINAL N/A Mar 30, 2004


Manufacturing Plant Locations
New

Perrigo'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 Perrigo as present at those locations.

Country City Firm Name
United States
Eau Claire Perrigo Wisconsin, LLC
Allegan Perrigo Company PLC-Allegan Logistics Center
Bronx Perrigo New York, Inc.
West Palm Beach Perrigo Florida, Inc
Martin Perrigo Company PLC
India
Thane Perrigo Laboratories India Pvt Ltd





7. PERRIGO R AND D

Perrigo R And D Co has filed for 2 different strengths of generic version for Miconazole Nitrate. Given below are the details of the strengths of this generic introduced by Perrigo R And D.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4%

cream Over the counter VAGINAL N/A Jan 15, 2010
2%,1.2GM

cream, insert Over the counter TOPICAL, VAGINAL N/A Jun 2, 2010





8. TARO

Taro Pharmaceuticals Inc has filed for 2 different strengths of generic version for Miconazole Nitrate. Out of these 4% version comes by the name MICONAZOLE 3. Given below are the details of the strengths of this generic introduced by Taro.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2%

cream Over the counter VAGINAL N/A Jan 13, 1997
4%

cream Over the counter VAGINAL N/A Mar 2, 2005


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.





9. TEVA

Teva Pharmaceuticals Usa Inc has filed for 1 generic for Miconazole Nitrate. Given below are the details of the strengths of this generic introduced by Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2%

cream Discontinued VAGINAL N/A Jan 4, 1995


Manufacturing Plant Locations
New

Teva's manufacturing plants are situated in 6 countries - United States, India, Canada, Czech Republic, Ireland, Israel. Given below are the details of these plant locations as well as the firm names of Teva as present at those locations.

Country City Firm Name
United States
Horsham Teva Branded Pharmaceutical Products R&D
Malvern Teva Branded Pharmaceutical Products R&D, Inc.
Fort Dodge TEVA Animal Health Inc
Miami Teva Branded Pharmaceutical Products R & D, Inc.
India
Gajraula, Amroha Teva API India Private Ltd.
Bhind Teva API India Ltd- Malanpur
Canada
Markham Teva Canada Limited
Scarborough Teva Canada Limited
Stouffville Teva Canada Limited
Czech Republic
Opava Teva Czech Industries s.r.o.
Ireland
Dundalk Teva Laboratories Ireland Ltd
Israel
Kiryat-Shmona TEVA Medical Ltd.





10. TEVA PHARMS

Teva Pharmaceuticals Usa has filed for 1 generic for Miconazole Nitrate. Given below are the details of the strengths of this generic introduced by Teva Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2%

cream Discontinued VAGINAL N/A Oct 30, 1992