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 are two patents 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
Annual sales in 2021 were $138mm indicating the motivation for generic entry (peak sales were $689mm in 2010).
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
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Questions you can ask:
- What is the 5 year forecast for LANSOPRAZOLE?
- What are the global sales for LANSOPRAZOLE?
- What is Average Wholesale Price for LANSOPRAZOLE?
Summary for LANSOPRAZOLE
International Patents: | 3 |
US Patents: | 2 |
Applicants: | 28 |
NDAs: | 33 |
Finished Product Suppliers / Packagers: | 70 |
Raw Ingredient (Bulk) Api Vendors: | 162 |
Clinical Trials: | 181 |
Patent Applications: | 3,988 |
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 |
---|---|
Fu Jen Catholic University Hospital | Phase 4 |
Complejo Hospitalario de Navarra | Phase 4 |
San Raffaele University Hospital, Italy | 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 two US patents.
Patents protecting LANSOPRAZOLE
Orally disintegrating compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Teva Pharms | LANSOPRAZOLE | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 077255-002 | Nov 10, 2009 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Teva Pharms Usa | LANSOPRAZOLE | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 208784-001 | Sep 21, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Dr Reddys | LANSOPRAZOLE | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 210465-001 | Feb 1, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Teva Pharms Usa | LANSOPRAZOLE | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 208784-002 | Sep 21, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 |
---|---|---|---|
Israel | 255048 | הרכבים המתפוררים בפה (Orally disintegrating compositions) | ⤷ Sign Up |
European Patent Office | 3288556 | COMPOSITIONS À DÉSINTÉGRATION PAR VOIE ORALE (ORALLY DISINTEGRATING COMPOSITIONS) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2016174664 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LANSOPRAZOLE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0328535 | 96C0021 | Belgium | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 |
0174726 | 93C0021 | Belgium | ⤷ Sign Up | PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |