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Progesterone Patent Expiration

Progesterone is used for supporting embryo implantation and early pregnancy in infertile women undergoing assisted reproductive technology (ART) treatment. It was first introduced by Eli Lilly And Co in its drug Progesterone on Approved Prior to Jan 1, 1982. Other drugs containing Progesterone are Prometrium, Endometrin, Milprosa, Progestasert, Crinone. 18 different companies have introduced drugs containing Progesterone.


Progesterone Patents

Given below is the list of patents protecting Progesterone, 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
Milprosa US8580293 Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof Jan 21, 2030 Ferring Pharms Inc
Milprosa US10537584 Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof Feb 03, 2029 Ferring Pharms Inc
Milprosa US10548904 Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof Feb 03, 2029 Ferring Pharms Inc
Endometrin US7300664 Vaginally administrable progesterone-containing tablets and method for preparing same Nov 17, 2019

(Expired)

 Ferring
Endometrin US7320800 Vaginally administrable progesterone-containing tablets and method for preparing same Nov 17, 2019

(Expired)

 Ferring
Endometrin US7393543 Vaginally administratable progesterone-containing tablets and method for preparing same Nov 17, 2019

(Expired)

 Ferring
Crinone US5543150 Method of progesterone delivery and affect thereof Sep 15, 2013

(Expired)

 Allergan



Progesterone's Family Patents

Family Patents

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Progesterone Generics

Several generic applications have been filed for Progesterone. The first generic version for Progesterone was by Fresenius Kabi Usa Llc and was approved on Apr 25, 2001. And the latest generic version is by Accord Healthcare Inc and was approved on Nov 21, 2023.

Given below is the list of companies who have filed for Progesterone generic.


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 1 generic for Progesterone. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML injectable Discontinued INJECTION N/A Nov 21, 2023


2. AM REGENT

American Regent Inc has filed for 1 generic for Progesterone. Given below are the details of the strengths of this generic introduced by Am Regent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML injectable Discontinued INJECTION N/A Jun 22, 2009


3. AMNEAL PHARMS NY

Amneal Pharmaceuticals Of Ny Llc has filed for 2 different strengths of generic version for Progesterone. Given below are the details of the strengths of this generic introduced by Amneal Pharms Ny.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG capsule Prescription ORAL AB Sep 7, 2017
200MG capsule Prescription ORAL AB Sep 7, 2017


4. BIONPHARMA

Bionpharma Inc has filed for 2 different strengths of generic version for Progesterone. Given below are the details of the strengths of this generic introduced by Bionpharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG capsule Prescription ORAL AB Aug 16, 2013
200MG capsule Prescription ORAL AB Aug 16, 2013


5. DR REDDYS

Dr Reddys Laboratories Inc has filed for 2 different strengths of generic version for Progesterone. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG capsule Prescription ORAL AB Feb 28, 2017
100MG capsule Prescription ORAL AB Feb 28, 2017


6. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 3 different strengths of generic version for Progesterone. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG capsule Prescription ORAL AB Oct 26, 2018
200MG capsule Prescription ORAL AB Oct 26, 2018
50MG/ML

(reference standard)

injectable Prescription INJECTION AO Dec 6, 2018


7. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 1 generic for Progesterone. Given below are the details of the strengths of this generic introduced by Fresenius Kabi Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML injectable Prescription INJECTION AO Apr 25, 2001


8. HIKMA FARMACEUTICA

Hikma Farmaceutica (portugal) Sa has filed for 1 generic for Progesterone. Given below are the details of the strengths of this generic introduced by Hikma Farmaceutica.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML injectable Prescription INJECTION AO Oct 28, 2010


9. SOFGEN PHARMS

Sofgen Pharmaceuticals Llc has filed for 2 different strengths of generic version for Progesterone. Given below are the details of the strengths of this generic introduced by Sofgen Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG capsule Prescription ORAL AB Sep 28, 2012
200MG capsule Prescription ORAL AB Sep 28, 2012


10. TEVA PHARMS

Teva Pharmaceuticals Usa has filed for 2 different strengths of generic version for Progesterone. 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
200MG capsule Discontinued ORAL N/A Feb 29, 2012
100MG capsule Discontinued ORAL N/A Feb 29, 2012


11. XIROMED

Xiromed Pharma Espana Sl has filed for 3 different strengths of generic version for Progesterone. Given below are the details of the strengths of this generic introduced by Xiromed.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG capsule Prescription ORAL AB Oct 20, 2017
200MG capsule Prescription ORAL AB Oct 20, 2017
50MG/ML injectable Prescription INJECTION AO Jan 5, 2022