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PREVACID Drug 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. There is one patent protecting this drug and two Paragraph IV challenges.
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.
US ANDA Litigation and Generic Entry Outlook for Prevacid
Prevacid was eligible for patent challenges on May 10, 1999.
Annual sales in 2018 were $408mm indicating the motivation for generic entry (peak sales were $3.4bn in 2005).
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
Summary for PREVACID
Recent Clinical Trials for PREVACID
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Takeda | Phase 3 |
| Janssen Research & Development, LLC | Phase 1 |
| 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 | NDA | Submissiondate |
|---|---|---|---|---|
| PREVACID | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | lansoprazole | 021428 | 2006-12-27 |
| PREVACID | CAPSULE, DELAYED REL PELLETS;ORAL | lansoprazole | 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 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Perrigo Pharma Intl | PREVACID 24 HR | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 022327-001 | May 18, 2009 | OTC | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Takeda Pharms Na | PREVACID | lansoprazole | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021281-002 | May 3, 2001 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Takeda Pharms Na | PREVACID IV | lansoprazole | INJECTABLE;INTRAVENOUS | 021566-001 | May 27, 2004 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Takeda Pharms Usa | PREVACID | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 020406-002 | May 10, 1995 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Takeda Pharms Na | PREVACID | lansoprazole | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021281-001 | May 3, 2001 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| >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 | Start Trial | Start Trial |
| Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428-002 | Aug 30, 2002 | Start Trial | Start Trial |
| Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428-001 | Aug 30, 2002 | Start Trial | Start Trial |
| Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428-001 | Aug 30, 2002 | Start Trial | Start Trial |
| Takeda Pharms Na | PREVACID | lansoprazole | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021281-002 | May 3, 2001 | Start Trial | Start Trial |
| Takeda Pharms Na | PREVACID | lansoprazole | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021281-001 | May 3, 2001 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PREVACID
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 0006126 | Start Trial |
| Taiwan | I257311 | Start Trial |
| Singapore | 103291 | Start Trial |
| Taiwan | 585786 | Start Trial |
| Japan | H0720865 | Start Trial |
| Denmark | 356485 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for PREVACID
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0174726 | 93C0021 | Belgium | Start Trial | PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211 |
| 1129088 | 2014/008 | Ireland | Start Trial | 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 |
| 0328535 | 96C0021 | Belgium | Start Trial | 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 | Start Trial | SPC/GB94/011, EXPIRES: 20051210 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
