LUBIPROSTONE Drug Patent Profile
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When do Lubiprostone patents expire, and when can generic versions of Lubiprostone launch?
Lubiprostone is a drug marketed by Amneal, Anchen Pharms, Dr Reddys, Teva Pharms Usa Inc, and Zydus Pharms. and is included in five NDAs.
The generic ingredient in LUBIPROSTONE is lubiprostone. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the lubiprostone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lubiprostone
A generic version of LUBIPROSTONE was approved as lubiprostone by AMNEAL on November 30th, 2021.
Summary for LUBIPROSTONE
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 87 |
| Clinical Trials: | 47 |
| Patent Applications: | 1,409 |
| Drug Prices: | Drug price information for LUBIPROSTONE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LUBIPROSTONE |
| What excipients (inactive ingredients) are in LUBIPROSTONE? | LUBIPROSTONE excipients list |
| DailyMed Link: | LUBIPROSTONE at DailyMed |
Recent Clinical Trials for LUBIPROSTONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Alexandria University | Phase 3 |
| Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Phase 4 |
| Helwan University | Phase 3 |
Pharmacology for LUBIPROSTONE
| Drug Class | Chloride Channel Activator |
| Mechanism of Action | Chloride Channel Activators |
Medical Subject Heading (MeSH) Categories for LUBIPROSTONE
Anatomical Therapeutic Chemical (ATC) Classes for LUBIPROSTONE
Paragraph IV (Patent) Challenges for LUBIPROSTONE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| AMITIZA | Capsules | lubiprostone | 8 mcg and 24 mcg | 021908 | 1 | 2012-08-20 |
US Patents and Regulatory Information for LUBIPROSTONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal | LUBIPROSTONE | lubiprostone | CAPSULE;ORAL | 209450-001 | Nov 30, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva Pharms Usa Inc | LUBIPROSTONE | lubiprostone | CAPSULE;ORAL | 209920-001 | Jan 18, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Anchen Pharms | LUBIPROSTONE | lubiprostone | CAPSULE;ORAL | 201442-002 | Jun 27, 2022 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
