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Generated: July 25, 2017
What are the generic drug sources for lansoprazole and what is the scope of lansoprazole freedom to operate?
Lansoprazole is the generic ingredient in seven branded drugs marketed by Labs Liconsa, Natco Pharma Ltd, Takeda Pharms Usa, Sun Pharm Inds Ltd, Krka Tovarna Zdravil, Perrigo R And D, Dexcel Pharma, Wockhardt Ltd, Glaxosmithkline Cons, Ani Pharms Inc, Sandoz, Teva Pharms, Ajanta Pharma Ltd, Mylan Pharms Inc, Zydus Hlthcare, Takeda Pharms Na, Dr Reddys Labs Ltd, and Wockhardt Usa, and is included in twenty-five NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 7 |
| Patents: | 6 |
| Applicants: | 18 |
| NDAs: | 25 |
| Drug Master File Entries: see list | 54 |
| Suppliers / Packagers: see list | 85 |
| Bulk Api Vendors: see list | 81 |
| Clinical Trials: see list | 118 |
| Patent Applications: see list | 6,423 |
| Therapeutic Class: | Gastrointestinal Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | lansoprazole at DailyMed |
| Drug Class | Proton Pump Inhibitor |
| Mechanism of Action | Proton Pump Inhibitors |
| Physiological Effect | Inhibition Gastric Acid Secretion |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL | 021428-001 | Aug 30, 2002 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Labs Liconsa | LANSOPRAZOLE | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 203203-002 | Jul 25, 2016 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Zydus Hlthcare | LANSOPRAZOLE | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 202366-001 | Aug 19, 2013 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Ajanta Pharma Ltd | LANSOPRAZOLE | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 203957-002 | Oct 14, 2016 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Takeda Pharms Na | PREVACID NAPRAPAC 500 (COPACKAGED) | lansoprazole; naproxen | CAPSULE, DELAYED REL PELLETS, TABLET;ORAL | 021507-004 | Nov 14, 2003 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Takeda Pharms Usa | PREVACID | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 020406-001 | May 10, 1995 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Takeda Pharms Usa | PREVACID | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 020406-002 | May 10, 1995 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL | 021428-001 | Aug 30, 2002 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL | 021428-001 | Aug 30, 2002 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Takeda Pharms Usa | PREVACID | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 020406-002 | May 10, 1995 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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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 | ► Subscribe | |||||||||||||||||||||||||||
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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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Austria | 291418 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 1561458 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2000302681 | ► Subscribe | |||||||||||||||||||||||||||
| Austria | 348601 | ► Subscribe | |||||||||||||||||||||||||||
| Austria | 481090 | ► Subscribe | |||||||||||||||||||||||||||
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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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0021 | Belgium | ► Subscribe | 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 | ► Subscribe | PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211 | ||||||||||||||||||||||||||
| 14/008 | Ireland | ► Subscribe | 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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Serving 500+ biopharmaceutical companies globally:
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 verifification 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.
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