PREVACID Drug Patent Profile
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Which patents cover Prevacid, and what generic alternatives are available?
Prevacid is a drug marketed by Takeda Pharms Usa, Takeda Pharms Na, and Perrigo Pharma Intl. and is included in six NDAs.
The generic ingredient in PREVACID is lansoprazole; naproxen. There are fifty-six drug master file entries for this compound. Additional details are available on the lansoprazole; naproxen profile page.
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Summary for PREVACID
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 162 |
| Clinical Trials: | 42 |
| Patent Applications: | 3,976 |
| Drug Prices: | Drug price information for PREVACID |
| Drug Sales Revenues: | Drug sales revenues for PREVACID |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PREVACID |
| What excipients (inactive ingredients) are in PREVACID? | PREVACID excipients list |
| DailyMed Link: | PREVACID at DailyMed |
Recent Clinical Trials for PREVACID
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Janssen Research & Development, LLC | Phase 1 |
| McGill University Health Centre/Research Institute of the McGill University Health Centre | Phase 4 |
| McGill University Health Center | Phase 4 |
Pharmacology for PREVACID
| Drug Class | Proton Pump Inhibitor |
| Mechanism of Action | Proton Pump Inhibitors |
| Physiological Effect | Inhibition Gastric Acid Secretion |
Paragraph IV (Patent) Challenges for PREVACID
| 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 PREVACID
| 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 | CAPSULE, DELAYED REL PELLETS;ORAL | 020406-001 | May 10, 1995 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Perrigo Pharma Intl | PREVACID 24 HR | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 022327-001 | May 18, 2009 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Takeda Pharms Na | PREVACID | lansoprazole | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021281-002 | May 3, 2001 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Takeda Pharms Na | PREVACID IV | lansoprazole | INJECTABLE;INTRAVENOUS | 021566-001 | May 27, 2004 | DISCN | Yes | 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 |
Expired US Patents for PREVACID
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428-002 | Aug 30, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428-001 | Aug 30, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428-002 | Aug 30, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | PREVACID | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 020406-002 | May 10, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PREVACID
See the table below for patents covering PREVACID around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 481090 | ⤷ Sign Up | |
| China | 1195500 | ⤷ Sign Up | |
| Finland | 104045 | ⤷ Sign Up | |
| South Africa | 200100285 | Rapidly disintegrable solid preparation. | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PREVACID
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 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 |
| 0174726 | SPC/GB94/011 | United Kingdom | ⤷ Sign Up | SPC/GB94/011, EXPIRES: 20051210 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 verification 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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