LANSOPRAZOLE Drug Patent Profile
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Which patents cover Lansoprazole, and when can generic versions of Lansoprazole launch?
Lansoprazole is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Breckenridge, Chartwell Molecular, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Hetero Labs Ltd Iii, Inventia, Krka Tovarna Zdravil, Lannett Co Inc, Mylan, Mylan Pharms Inc, Natco, Natco Pharma Ltd, Perrigo R And D, Sandoz, Sun Pharm, Teva Pharms, Wockhardt, Xiromed, Zydus Hlthcare, Ani Pharms, Aurobindo Pharma Ltd, Dexcel, Dr Reddys, Teva Pharms Usa, Zydus Pharms, and Rising. and is included in thirty-three NDAs. There is one patent protecting this drug.
This drug has three patent family members in three countries.
The generic ingredient in LANSOPRAZOLE is amoxicillin; clarithromycin; lansoprazole. There are forty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amoxicillin; clarithromycin; lansoprazole profile page.
DrugPatentWatch® Generic Entry Outlook for Lansoprazole
There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for LANSOPRAZOLE
International Patents: | 3 |
US Patents: | 1 |
Applicants: | 28 |
NDAs: | 33 |
Finished Product Suppliers / Packagers: | 69 |
Raw Ingredient (Bulk) Api Vendors: | 162 |
Clinical Trials: | 178 |
Patent Applications: | 3,995 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for LANSOPRAZOLE |
Drug Sales Revenues: | Drug sales revenues for LANSOPRAZOLE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LANSOPRAZOLE |
What excipients (inactive ingredients) are in LANSOPRAZOLE? | LANSOPRAZOLE excipients list |
DailyMed Link: | LANSOPRAZOLE at DailyMed |
Recent Clinical Trials for LANSOPRAZOLE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Daejeon St. Mary's hospital | Phase 4 |
Jeil Pharmaceutical Co., Ltd. | Phase 4 |
Nanfang Hospital of Southern Medical University | Phase 4 |
Pharmacology for LANSOPRAZOLE
Drug Class | Proton Pump Inhibitor |
Mechanism of Action | Proton Pump Inhibitors |
Physiological Effect | Inhibition Gastric Acid Secretion |
Medical Subject Heading (MeSH) Categories for LANSOPRAZOLE
Anatomical Therapeutic Chemical (ATC) Classes for LANSOPRAZOLE
Paragraph IV (Patent) Challenges for LANSOPRAZOLE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
PREVACID | Delayed-release Orally Disintegrating Tablets | lansoprazole | 15 mg and 30 mg | 021428 | 1 | 2006-12-27 |
PREVACID | Delayed-release Pellets/Capsules | lansoprazole | 15 mg and 30 mg | 020406 | 2005-12-05 |
US Patents and Regulatory Information for LANSOPRAZOLE
LANSOPRAZOLE is protected by one US patents.
Patents protecting LANSOPRAZOLE
Orally disintegrating compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aurobindo Pharma Ltd | LANSOPRAZOLE | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 207167-001 | Mar 28, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Teva Pharms | LANSOPRAZOLE | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 077255-002 | Nov 10, 2009 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Teva Pharms Usa | LANSOPRAZOLE | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 208784-002 | Sep 21, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Dr Reddys | LANSOPRAZOLE | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 210465-002 | Feb 1, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Zydus Pharms | LANSOPRAZOLE | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 200816-001 | Nov 27, 2018 | AB | RX | 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 |
International Patents for LANSOPRAZOLE
See the table below for patents covering LANSOPRAZOLE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 3288556 | COMPOSITIONS À DÉSINTÉGRATION PAR VOIE ORALE (ORALLY DISINTEGRATING COMPOSITIONS) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2016174664 | ⤷ Try a Trial | |
Israel | 255048 | הרכבים המתפוררים בפה (Orally disintegrating compositions) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LANSOPRAZOLE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0174726 | 93C0021 | Belgium | ⤷ Try a Trial | PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211 |
0328535 | 96C0021 | Belgium | ⤷ Try a Trial | PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209 |
1129088 | 2014/008 | Ireland | ⤷ Try a Trial | PRODUCT NAME: DEXLANSOPRAZOLE OR A SALT THEREOF; NAT REGISTRATION NO/DATE: PA1864/001/001-002;PA1864/002/001-002 20131125; FIRST REGISTRATION NO/DATE: 47911 47912 47913 47914 20130919 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |