Drug
Who makes lubiprostone?
18 companies list lubiprostone as a human prescription drug, including under the names Amitiza, Amitza. Forms: capsule; capsule, gelatin coated. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing lubiprostone
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Proficient Rx LPUnited States | capsule, gelatin coated | ANDA, NDA AUTHORIZED GENERICANDA209920, NDA021908 | 5 | 1 |
| SpecGx LLCUnited States | capsule, gelatin coated | NDA, NDA AUTHORIZED GENERICNDA021908 | 4 | 5 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | capsule; capsule, gelatin coated | ANDA, NDA AUTHORIZED GENERICANDA214131, NDA021908 | 4 | 1 |
| Dr. Reddy's Laboratories LimitedIndia | capsule, gelatin coated | NDA AUTHORIZED GENERICNDA021908 | 2 | 15 |
| Sun Pharmaceutical Industries LimitedIndia | capsule, gelatin coated | NDA AUTHORIZED GENERICNDA021908 | 2 | 13 |
| Zydus Lifesciences LimitedIndia | capsule | ANDAANDA214131 | 2 | 12 |
| Takeda Pharmaceuticals U.S.A., Inc.Germany | capsule, gelatin coated | NDANDA021908 | 2 | 7 |
| Teva Pharmaceutical Industries Ltd.Canada | capsule, gelatin coated | ANDAANDA209920 | 2 | 6 |
| NATCO PHARMA LIMITEDIndia | capsule, gelatin coated | NDA AUTHORIZED GENERICNDA021908 | 2 | 5 |
| Par Health USA, LLCIndia | capsule, gelatin coated | NDA AUTHORIZED GENERICNDA021908 | 2 | 5 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | capsule, gelatin coated | ANDAANDA209920 | 2 | 5 |
| Amneal Ireland LimitedIreland | capsule | ANDAANDA209450 | 2 | 1 |
| Camber Pharmaceuticals, Inc.United States | capsule | ANDAANDA218640 | 2 | 1 |
| Direct RxUnited States | capsule, gelatin coated | ANDA, NDA AUTHORIZED GENERICANDA209920, NDA021908 | 2 | 1 |
| Golden State Medical Supply Inc.United States | capsule, gelatin coated | NDA AUTHORIZED GENERICNDA021908 | 2 | 1 |
| Zydus Pharmaceuticals USA Inc.India | capsule | ANDAANDA214131 | 2 | 1 |
| Advanced Rx of Tennessee, LLC | capsule, gelatin coated | NDA AUTHORIZED GENERICNDA021908 | 2 | 0 |
| Northstar Rx, LLC, | capsule | ANDAANDA218640 | 2 | 0 |
Bulk ingredient listings
- Zhejiang Ausun Pharmaceutical Co., Ltd.China · 2 NDC
- Chirogate International Inc.Taiwan · 1 NDC
- Dr. Reddy's Laboratories LimitedIndia · 1 NDC
- Everlight Chemical Industrial Corporation Kuanyin II Plant · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- YS Life Science Co., Ltd.South Korea · 1 NDC
Orange Book patents
3 unexpired patents list lubiprostone as the active ingredient, expiring between Jan 2027 and Oct 2027. Application holder: SUCAMPO PHARMA AMERICAS LLC.
Enquiry
Common questions
- Who makes lubiprostone?
- 18 companies list lubiprostone as a human prescription drug in the openFDA NDC Directory, led by Proficient Rx LP, SpecGx LLC, ASCLEMED USA INC. DBA ENOVACHEM, Dr. Reddy's Laboratories Limited, Sun Pharmaceutical Industries Limited. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Amitiza?
- 10 companies list lubiprostone under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies lubiprostone active ingredient?
- 6 companies list lubiprostone as a bulk ingredient, including Zhejiang Ausun Pharmaceutical Co., Ltd., Chirogate International Inc., Dr. Reddy's Laboratories Limited, Everlight Chemical Industrial Corporation Kuanyin II Plant.