Lubiprostone Patent Expiration

Lubiprostone is Used for treating constipation, irritable bowel syndrome, and abdominal discomfort associated with irritable bowel syndrome. It was first introduced by Sucampo Pharma Americas Llc in its drug Amitiza on Jan 31, 2006. 6 different companies have introduced drugs containing Lubiprostone.


Lubiprostone Patents

Given below is the list of patents protecting Lubiprostone, 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
Amitiza US8026393 Soft-gelatin capsule formulation Oct 25, 2027 Sucampo Pharma Llc
Amitiza US8338639 Soft-gelatin capsule formulation Jan 23, 2027 Sucampo Pharma Llc
Amitiza US8779187 Soft-gelatin capsule formulation Jan 23, 2027 Sucampo Pharma Llc
Amitiza US8748481 Method for treating gastrointestinal disorder Sep 01, 2025 Sucampo Pharma Llc
Amitiza US7795312 Method for treating abdominal discomfort Sep 17, 2024

(Expired)

Sucampo Pharma Llc
Amitiza US6982283 Method for treating drug-induced constipation Dec 04, 2022

(Expired)

Sucampo Pharma Llc
Amitiza US8097653 Dosage unit comprising a prostaglandin analog for treating constipation Nov 14, 2022

(Expired)

Sucampo Pharma Llc
Amitiza US8389542 Dosage unit comprising a prostaglandin analog for treating constipation Nov 14, 2022

(Expired)

Sucampo Pharma Llc
Amitiza US7064148 Chloride channel opener Aug 30, 2022

(Expired)

Sucampo Pharma Llc
Amitiza US8088934 Composition and method for stabilizing the same May 18, 2021

(Expired)

Sucampo Pharma Llc
Amitiza US6583174 Composition and method for stabilizing the same Oct 16, 2020

(Expired)

Sucampo Pharma Llc
Amitiza US7417067 Composition and method for stabilizing the same Oct 16, 2020

(Expired)

Sucampo Pharma Llc
Amitiza US8097649 Composition and method for stabilizing the same Oct 16, 2020

(Expired)

Sucampo Pharma Llc
Amitiza US6414016 Anti-constipation composition Sep 05, 2020

(Expired)

Sucampo Pharma Llc
Amitiza US8071613 Anti-constipation composition Sep 05, 2020

(Expired)

Sucampo Pharma Llc
Amitiza US8114890 Anti-constipation composition Sep 05, 2020

(Expired)

Sucampo Pharma Llc
Amitiza US5284858 Prostaglandins E and anti ulcers containing same Jul 14, 2014

(Expired)

Sucampo Pharma Llc



Lubiprostone's Family Patents

Family Patents

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Lubiprostone Generic API Manufacturers

Several generic applications have been filed for Lubiprostone. The first generic version for Lubiprostone was by Amneal Pharmaceuticals Llc and was approved on Nov 30, 2021. And the latest generic version is by Zydus Pharmaceuticals Usa Inc and was approved on Mar 23, 2023.

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


1. AMNEAL

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
8MCG capsule Prescription ORAL AB Nov 30, 2021
24MCG capsule Prescription ORAL AB Nov 30, 2021


Manufacturing Plant Locations
New

Amneal'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 Amneal as present at those locations.

Country City Firm Name
United States
East Hanover Amneal Pharmaceuticals LLC
Bridgewater Amneal Complex Products Research LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Piscataway Amneal Pharmaceuticals, LLC
Paterson Amneal Pharmaceuticals, Llc
Glasgow Amneal Pharmaceuticals LLC
Branchburg Amneal Pharmaceuticals, LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
India
Hyderabad Amneal Oncology Private Limited
Matoda Amneal Pharmaceuticals Private Ltd.
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.




2. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 2 different strengths of generic version for Lubiprostone. 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
8MCG capsule Prescription ORAL AB Feb 8, 2022
24MCG capsule Prescription ORAL AB Feb 8, 2022






3. ENDO OPERATIONS

Endo Operations Ltd has filed for 2 different strengths of generic version for Lubiprostone. Given below are the details of the strengths of this generic introduced by Endo Operations.

Strength Dosage Form Availability Application Pathway TE code Launch Date
8MCG capsule Discontinued ORAL N/A Jun 27, 2022
24MCG capsule Discontinued ORAL N/A Jun 27, 2022






4. TEVA PHARMS USA INC

Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Lubiprostone. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
24MCG capsule Prescription ORAL AB Jan 18, 2022
8MCG capsule Prescription ORAL AB Jan 18, 2022






5. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Lubiprostone. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
24MCG capsule Prescription ORAL AB Mar 23, 2023
8MCG capsule Prescription ORAL AB Mar 23, 2023