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 Norplant System In Plastic Container, Liletta, Mirena, Kyleena, Plan B One-Step, Skyla, Jadelle, Plan B, Levonorgestrel. 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
Kyleena US10561524 Inserter Sep 16, 2029 Bayer Hlthcare
Kyleena US10987244 Inserter Apr 01, 2031 Bayer Hlthcare
Kyleena US11628088 Ultrasonically detectable intrauterine system and a method for enhancing ultrasound detection Feb 07, 2027 Bayer Hlthcare
Kyleena US11850182 Inserter Sep 14, 2029 Bayer Hlthcare
Kyleena US7252839 Delivery system and a manufacturing process of a delivery system Nov 13, 2023

(Expired)

Bayer Hlthcare
Kyleena US9615965 Inserter Sep 16, 2029 Bayer Hlthcare
Kyleena US9668912 Inserter Apr 01, 2031 Bayer Hlthcare
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 US11571328 IUD insertion devices Sep 07, 2040 Medicines360
Liletta US12004992 Kits for intrauterine systems and IUD insertion devices Oct 06, 2033 Medicines360
Mirena US10561524 Inserter Sep 16, 2029 Bayer Hlthcare
Mirena US10987244 Inserter Apr 01, 2031 Bayer Hlthcare
Mirena US11850182 Inserter Sep 14, 2029 Bayer Hlthcare
Mirena US5785053 Inserter for the positioning of an intrauterine device Dec 05, 2015

(Expired)

Bayer Hlthcare
Mirena US9615965 Inserter Sep 16, 2029 Bayer Hlthcare
Mirena US9668912 Inserter Apr 01, 2031 Bayer Hlthcare
Skyla US10561524 Inserter Sep 16, 2029 Bayer Hlthcare
Skyla US10987244 Inserter Apr 01, 2031 Bayer Hlthcare
Skyla US11628088 Ultrasonically detectable intrauterine system and a method for enhancing ultrasound detection Feb 07, 2027 Bayer Hlthcare
Skyla US11850182 Inserter Sep 14, 2029 Bayer Hlthcare
Skyla US5785053 Inserter for the positioning of an intrauterine device Dec 05, 2015

(Expired)

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

(Expired)

Bayer Hlthcare
Skyla US9615965 Inserter Sep 16, 2029 Bayer Hlthcare
Skyla US9668912 Inserter Apr 01, 2031 Bayer Hlthcare


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Levonorgestrel Generics

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.


1. 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


2. 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


3. 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


4. 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


5. 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


6. 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


7. 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


8. 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


9. 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


10. 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


11. 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


12. 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


13. 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


14. 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


15. 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


16. 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