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Last Updated: November 27, 2022

Lubiprostone - Generic Drug Details


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What are the generic drug sources for lubiprostone and what is the scope of freedom to operate?

Lubiprostone is the generic ingredient in two branded drugs marketed by Sucampo Pharma Llc, Amneal, Anchen Pharms, Dr Reddys, and Teva Pharms Usa Inc, and is included in five NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lubiprostone has one hundred and thirty patent family members in twenty-four countries.

There are ten drug master file entries for lubiprostone. Five suppliers are listed for this compound.

Drug Prices for lubiprostone

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Recent Clinical Trials for lubiprostone

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Alexandria UniversityPhase 3
Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshPhase 4
Rajavithi HospitalPhase 4

See all lubiprostone clinical trials

Pharmacology for lubiprostone
Medical Subject Heading (MeSH) Categories 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
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-002 Apr 29, 2008 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-002 Apr 29, 2008 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for lubiprostone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 See Plans and Pricing See Plans and Pricing
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 See Plans and Pricing See Plans and Pricing
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-002 Apr 29, 2008 See Plans and Pricing See Plans and Pricing
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 See Plans and Pricing See Plans and Pricing
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-002 Apr 29, 2008 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for lubiprostone

Country Patent Number Title Estimated Expiration
Mexico 2007002602 DERIVADOS DE PROSTAGLANDINA PARA EL TRATAMIENTO DE TRASTORNOS GASTROINTESTINALES. (PROSTAGLANDIN DERIVATIVES FOR TREATING GASTROINTESTINAL DISORDER.) See Plans and Pricing
Japan 4889219 See Plans and Pricing
Portugal 2298314 See Plans and Pricing
Argentina 098997 UNIDAD DE DOSIFICACIÓN QUE COMPRENDE UN ANÁLOGO DE PROSTAGLANDINA PARA EL TRATAMIENTO DE LA CONSTIPACIÓN See Plans and Pricing
Spain 2603381 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for lubiprostone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1315485 132016000025193 Italy See Plans and Pricing PRODUCT NAME: LUBIPROSTONE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(AMITIZA); AUTHORISATION NUMBER(S) AND DATE(S): PL 21341/0003, 20120910;043833019-021, 20150526
1315485 2015/028 Ireland See Plans and Pricing PRODUCT NAME: LUBIPROSTONE AND PHARMACEUTICALLY ACCEPTABLE SALTS FOR LUBIPROSTONE.; NAT REGISTRATION NO/DATE: PA148/002/001 20150213; FIRST REGISTRATION NO/DATE: PL21341/0003-0001 20120910
1315485 2015C/048 Belgium See Plans and Pricing PRODUCT NAME: LUBIPROSTONE; AUTHORISATION NUMBER AND DATE: PL21341/0003 20150317
2298314 92826 Luxembourg See Plans and Pricing PRODUCT NAME: LUBIPROSTONE, INCLUANT LES SELS PHARMACEUTIQUEMENT ACCEPTABLES, LES ESTERS OU LES AMIDES DE LA LUBIPROSTONE. FIRST REGISTRATION: 20120910
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.