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
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
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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 Ascent Pharmaceuticals Inc and was approved on Jan 2, 2025.
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 |
|---|---|---|---|---|---|
| 24MCG | capsule | Prescription | ORAL | AB | Nov 30, 2021 |
| 8MCG | 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 |
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| India |
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2. ASCENT PHARMS INC
Ascent Pharmaceuticals 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 Ascent Pharms Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 24MCG | capsule | Prescription | ORAL | AB | Jan 2, 2025 |
| 8MCG | capsule | Prescription | ORAL | AB | Jan 2, 2025 |
3. 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 |
4. 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 |
5. 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 |
6. 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 |
|---|---|---|---|---|---|
| 8MCG | capsule | Prescription | ORAL | AB | Mar 23, 2023 |
| 24MCG | capsule | Prescription | ORAL | AB | Mar 23, 2023 |