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Levonorgestrel Patent Expiration

Levonorgestrel is Used for preventing pregnancy with the intrauterine system (IUS). It was first introduced by Population Council in its drug Norplant on Dec 10, 1990. Other drugs containing Levonorgestrel are Levonorgestrel, Jadelle, Plan B, Skyla, Norplant System In Plastic Container, Mirena, Liletta, Plan B One-Step, Kyleena. 20 different companies have introduced drugs containing Levonorgestrel.


Levonorgestrel Patents

Given below is the list of patents protecting Levonorgestrel, 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
Liletta US11571328 IUD insertion devices Sep 07, 2040 Medicines360
Liletta US10028858 Intrauterine systems, IUD insertion devices, and related methods and kits therefor Mar 22, 2034 Medicines360
Liletta US11090186 Methods for using intrauterine systems and IUD insertion devices Oct 24, 2033 Medicines360
Liletta US12004992 Kits for intrauterine systems and IUD insertion devices Oct 06, 2033 Medicines360
Kyleena US10987244 Inserter Apr 01, 2031 Bayer Hlthcare
Kyleena US9668912 Inserter Apr 01, 2031 Bayer Hlthcare
Mirena US10987244 Inserter Apr 01, 2031 Bayer Hlthcare
Mirena US9668912 Inserter Apr 01, 2031 Bayer Hlthcare
Skyla US10987244 Inserter Apr 01, 2031 Bayer Hlthcare
Skyla US9668912 Inserter Apr 01, 2031 Bayer Hlthcare
Kyleena US10561524 Inserter Sep 16, 2029 Bayer Hlthcare
Kyleena US9615965 Inserter Sep 16, 2029 Bayer Hlthcare
Mirena US10561524 Inserter Sep 16, 2029 Bayer Hlthcare
Mirena US9615965 Inserter Sep 16, 2029 Bayer Hlthcare
Skyla US10561524 Inserter Sep 16, 2029 Bayer Hlthcare
Skyla US9615965 Inserter Sep 16, 2029 Bayer Hlthcare
Kyleena US11850182 Inserter Sep 14, 2029 Bayer Hlthcare
Mirena US11850182 Inserter Sep 14, 2029 Bayer Hlthcare
Skyla US11850182 Inserter Sep 14, 2029 Bayer Hlthcare
Kyleena US11628088 Ultrasonically detectable intrauterine system and a method for enhancing ultrasound detection Feb 07, 2027 Bayer Hlthcare
Skyla US11628088 Ultrasonically detectable intrauterine system and a method for enhancing ultrasound detection Feb 07, 2027 Bayer Hlthcare
Kyleena US7252839 Delivery system and a manufacturing process of a delivery system Nov 13, 2023

(Expired)

 Bayer Hlthcare
Skyla US7252839 Delivery system and a manufacturing process of a delivery system Nov 13, 2023

(Expired)

 Bayer Hlthcare
Mirena US5785053 Inserter for the positioning of an intrauterine device Dec 05, 2015

(Expired)

 Bayer Hlthcare
Skyla US5785053 Inserter for the positioning of an intrauterine device Dec 05, 2015

(Expired)

 Bayer Hlthcare



Levonorgestrel's Family Patents

Family Patents

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Levonorgestrel Generic API Manufacturers

Several generic applications have been filed for Levonorgestrel. The first generic version for Levonorgestrel was by Watson Laboratories Inc and was approved on Jun 24, 2009. And the latest generic version is by Naari Pte Ltd and was approved on May 2, 2019.

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


1. ALVOGEN

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5MG

tablet Discontinued ORAL N/A Jun 5, 2015


Manufacturing Plant Locations
New

Alvogen'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 Alvogen as present at those locations.

Country City Firm Name
United States
Morristown Alvogen, Inc





2. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 1 generic for Levonorgestrel. This 1.5mg version comes by the name ATHENTIA NEXT. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5MG

tablet Over the counter ORAL N/A Dec 8, 2015


Manufacturing Plant Locations
New

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

Country City Firm Name
India
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Sangareddy Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
Bachupally Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





3. FDN CONSUMER

Foundation Consumer Healthcare Llc has filed for 2 different strengths of generic version for Levonorgestrel. Given below are the details of the strengths of this generic introduced by Fdn Consumer.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

tablet Discontinued ORAL N/A Aug 28, 2009
1.5MG

tablet Discontinued ORAL N/A Jul 12, 2012





4. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 1 generic for Levonorgestrel. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5MG

tablet Over the counter ORAL N/A Mar 25, 2016





5. L PERRIGO CO

L Perrigo Co has filed for 1 generic for Levonorgestrel. 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
0.75MG

tablet Discontinued ORAL N/A Dec 30, 2010





6. LABORATOIRE HRA

Laboratoire Hra Pharma has filed for 1 generic for Levonorgestrel. Given below are the details of the strengths of this generic introduced by Laboratoire Hra.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5MG

tablet Over the counter ORAL N/A Jul 3, 2018


Manufacturing Plant Locations
New

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

Country City Firm Name
France
Chatillon Laboratoire HRA Pharma





7. LOTUS PHARM CO LTD

Lotus Pharmaceutical Co Ltd Nantou Plant has filed for 1 generic for Levonorgestrel. Given below are the details of the strengths of this generic introduced by Lotus Pharm Co Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.75MG

tablet Discontinued ORAL N/A Sep 2, 2016





8. LUPIN LTD

Lupin Ltd has filed for 2 different strengths of generic version for Levonorgestrel. Out of these 1.5mg version comes by the name FALLBACK SOLO. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.75MG

tablet Discontinued ORAL N/A Jan 23, 2013
1.5MG

tablet Over the counter ORAL N/A Jun 19, 2014


Manufacturing Plant Locations
New

Lupin Ltd'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 Lupin Ltd as present at those locations.

Country City Firm Name
India
Aurangabad Lupin Ltd.





9. NAARI PTE LTD

Naari Pte Ltd has filed for 1 generic for Levonorgestrel. Given below are the details of the strengths of this generic introduced by Naari Pte Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5MG

tablet Over the counter ORAL N/A May 2, 2019





10. NOVAST LABS

Novast Laboratories Ltd has filed for 1 generic for Levonorgestrel. This 1.5mg version comes by the name HER STYLE. Given below are the details of the strengths of this generic introduced by Novast Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5MG

tablet Over the counter ORAL N/A Mar 11, 2016





11. NOVEL LABS INC

Novel Laboratories Inc has filed for 1 generic for Levonorgestrel. Given below are the details of the strengths of this generic introduced by Novel Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5MG

tablet Over the counter ORAL N/A Feb 22, 2013





12. PERRIGO R AND D

Perrigo R And D Co has filed for 1 generic for Levonorgestrel. 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
1.5MG

tablet Over the counter ORAL N/A Aug 20, 2014





13. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 1 generic for Levonorgestrel. This 1.5mg version comes by the name OPCICON ONE-STEP. Given below are the details of the strengths of this generic introduced by Sun Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5MG

tablet Over the counter ORAL N/A Sep 11, 2014


Manufacturing Plant Locations
New

Sun Pharm'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 Sun Pharm as present at those locations.

Country City Firm Name
United States
Billerica Sun Pharmaceutical Industries, Inc.
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
Lexington Sun Pharmaceutical Industries Inc
India
Dadra Sun Pharmaceutical Industries Limited
Halol Sun Pharmaceutical Industries Ltd.
Vadodara Sun Pharmaceutical Industries Ltd
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
Punjab Sun Pharmaceutical Industries, Inc.
Ahmednagar Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Vadodara Sun Pharmaceutical Industries Ltd.
Mohali Sun Pharmaceutical Industries Limited
Baruch Sun Pharmaceutical Industries Ltd.
Bharuch Sun Pharmaceutical Industries Ltd
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
New Delhi Sun Pharmaceutical Industries Limited





14. WATSON LABS

Watson Laboratories Inc has filed for 1 generic for Levonorgestrel. Given below are the details of the strengths of this generic introduced by Watson Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.75MG

tablet Discontinued ORAL N/A Jun 24, 2009





15. WATSON LABS INC

Watson Laboratories Inc has filed for 1 generic for Levonorgestrel. Given below are the details of the strengths of this generic introduced by Watson Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5MG

tablet Over the counter ORAL N/A Jul 12, 2012





16. XIROMED

Xiromed Pharma Espana Sl has filed for 2 different strengths of generic version for Levonorgestrel. Given below are the details of the strengths of this generic introduced by Xiromed.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5MG

tablet Over the counter ORAL N/A Sep 18, 2018
0.75MG

tablet Discontinued ORAL N/A Sep 2, 2016


Manufacturing Plant Locations
New

Xiromed'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 Xiromed as present at those locations.

Country City Firm Name
United States
Florham Park XIROMED LLC