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Lansoprazole - Generic Drug Details
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This ingredient has fifty-three patent family members in nineteen countries.
There are fifty-three drug master file entries for lansoprazole. Eighty-one suppliers are listed for this compound.
Summary for Generic Name: lansoprazole
| Tradenames: | 7 |
| Patents: | 5 |
| Applicants: | 17 |
| NDAs: | 24 |
| Drug Master File Entries: see list | 53 |
| Suppliers / Packaging: see list | 81 |
| Therapeutic Class: | Gastrointestinal Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: lansoprazole
| Drug Class | Proton Pump Inhibitor |
| Mechanism of Action | Proton Pump Inhibitors |
| Physiological Effect | Inhibition Gastric Acid Secretion |
Clinical Trials for: lansoprazole
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Takeda Pharms Na | PREVACID NAPRAPAC 375 (COPACKAGED) | lansoprazole; naproxen | CAPSULE, DELAYED REL PELLETS, TABLET;ORAL | 021507-003 | Nov 14, 2003 | DISCN | No | ||||||||||||||||||||||
Dr Reddys Labs Ltd | LANSOPRAZOLE | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 091269-001 | Oct 15, 2010 | RX | No | ||||||||||||||||||||||
Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL | 021428-001 | Aug 30, 2002 | RX | No | 6,328,994*PED | Nov 17, 2019 | Y | |||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: lansoprazole
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL | 021428-001 | Aug 30, 2002 | 5,464,632*PED | <disabled> | ||||||||||||||||||||||
Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL | 021428-002 | Aug 30, 2002 | 6,749,864 | <disabled> | ||||||||||||||||||||||
Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL | 021428-001 | Aug 30, 2002 | 5,013,743*PED | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Generic Ingredient: lansoprazole
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,070,805 | Rapidly disintegrable solid preparation | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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International Patent Family for Ingredient: lansoprazole
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| China | 1149077 | <disabled in preview> | |||||||||||||||||||||||||||
| Argentina | 019935 | <disabled in preview> | |||||||||||||||||||||||||||
| Japan | 2000103731 | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Supplementary Protection Certificates for Tradename: LANSOPRAZOLE
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0021 | Belgium | <disabled> | 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 | ||||||||||||||||||||||||||
| C0021 | Belgium | <disabled> | PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211 | ||||||||||||||||||||||||||
| 14/008 | Ireland | <disabled> | 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 | ||||||||||||||||||||||||||
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