Lansoprazole - Generic Drug Details
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What are the generic sources for lansoprazole and what is the scope of patent protection?
Lansoprazole
is the generic ingredient in seven branded drugs 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, Takeda Pharms Usa, Perrigo Pharma Intl, Takeda Pharms Na, Ani Pharms, Dexcel, Dr Reddys, Teva Pharms Usa, and Zydus Pharms, and is included in thirty-five NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Lansoprazole has nine patent family members in six countries.
There are fifty-six drug master file entries for lansoprazole. Seventy-five suppliers are listed for this compound.
Summary for lansoprazole
International Patents: | 9 |
US Patents: | 2 |
Tradenames: | 7 |
Applicants: | 29 |
NDAs: | 35 |
Drug Master File Entries: | 56 |
Finished Product Suppliers / Packagers: | 75 |
Raw Ingredient (Bulk) Api Vendors: | 160 |
Clinical Trials: | 176 |
Patent Applications: | 6,933 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends 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 |
---|---|
Nanfang Hospital of Southern Medical University | Phase 4 |
Future pharmaceutical industries | Phase 4 |
National Liver Institute, Egypt | 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
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sandoz | LANSOPRAZOLE | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 090331-001 | Apr 23, 2010 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Takeda Pharms Na | PREVACID NAPRAPAC 250 (COPACKAGED) | lansoprazole; naproxen | CAPSULE, DELAYED REL PELLETS, TABLET;ORAL | 021507-002 | Nov 14, 2003 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Dr Reddys | LANSOPRAZOLE | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 210465-002 | Feb 1, 2021 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Wockhardt | LANSOPRAZOLE | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 202176-001 | Sep 14, 2012 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428-001 | Aug 30, 2002 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Glenmark Pharms Inc | LANSOPRAZOLE | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 202727-001 | May 18, 2012 | OTC | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Takeda Pharms Na | PREVACID | lansoprazole | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021281-001 | May 3, 2001 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | 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 lansoprazole
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428-001 | Aug 30, 2002 | See Plans and Pricing | See Plans and Pricing |
Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428-001 | Aug 30, 2002 | See Plans and Pricing | See Plans and Pricing |
Takeda Pharms Na | PREVACID | lansoprazole | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021281-001 | May 3, 2001 | See Plans and Pricing | See Plans and Pricing |
Takeda Pharms Usa | PREVACID | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 020406-002 | May 10, 1995 | See Plans and Pricing | See Plans and Pricing |
Takeda Pharms Usa | PREVACID | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 020406-002 | May 10, 1995 | See Plans and Pricing | See Plans and Pricing |
Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428-002 | Aug 30, 2002 | See Plans and Pricing | See Plans and Pricing |
Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428-002 | Aug 30, 2002 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for lansoprazole
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 0215908 | See Plans and Pricing | |
Canada | 2419067 | COMPOSITION INJECTABLE COMRENANT UN COMPOSE DE BENZIMIDAZOLEET UN ALKALI FORT (INJECTABLE COMPOSITION COMPRISING BENZIMIDAZOLE COMPOUND ANDSTRONG ALKALI) | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 2016174664 | See Plans and Pricing | |
Japan | 4136340 | See Plans and Pricing | |
European Patent Office | 3288556 | COMPOSITIONS À DÉSINTÉGRATION PAR VOIE ORALE (ORALLY DISINTEGRATING COMPOSITIONS) | See Plans and Pricing |
Israel | 255048 | הרכבים המתפוררים בפה (Orally disintegrating compositions) | See Plans and Pricing |
Australia | 7875501 | See Plans and Pricing | |
>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 | See Plans and Pricing | 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 |
0174726 | 93C0021 | Belgium | See Plans and Pricing | PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211 |
1129088 | 2014/008 | Ireland | See Plans and Pricing | 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 |
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