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PREVACID Drug Profile
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This drug has fifty-three patent family members in nineteen countries.
The generic ingredient in PREVACID is lansoprazole; naproxen. There are fifty-three drug master file entries for this compound. Additional details are available on the lansoprazole; naproxen profile page.
Summary for Tradename: PREVACID
| Patents: | 5 |
| Applicants: | 3 |
| NDAs: | 6 |
| Suppliers / Packagers: see list | 8 |
| Drug Prices: : | see details |
Pharmacology for Tradename: PREVACID
| Drug Class | Proton Pump Inhibitor |
| Mechanism of Action | Proton Pump Inhibitors |
| Physiological Effect | Inhibition Gastric Acid Secretion |
Clinical Trials for: PREVACID
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | 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 | RX | No | ||||||||||||||||||||||
Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL | 021428-002 | Aug 30, 2002 | RX | Yes | 6,328,994*PED | Nov 17, 2019 | Y | |||||||||||||||||||
Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL | 021428-001 | Aug 30, 2002 | RX | No | 7,399,485*PED | Nov 26, 2018 | Y | |||||||||||||||||||
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Expired Patents for Tradename: PREVACID
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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 | 020406-002 | May 10, 1995 | 5,013,743*PED | <disabled> | ||||||||||||||||||||||
Takeda Pharms Usa | PREVACID | lansoprazole | TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL | 021428-001 | Aug 30, 2002 | 5,093,132*PED | <disabled> | ||||||||||||||||||||||
Takeda Pharms Na | PREVACID | lansoprazole | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021281-001 | May 3, 2001 | 4,689,333 | <disabled> | ||||||||||||||||||||||
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Paragraph IV activity for: PREVACID
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| lansoprazole | Delayed-release Orally Disinte | 15 mg and 30 mg | Prevacid | 12/27/2006 |
| lansoprazole | Delayed-release Pellets/Capsul | 15 mg and 30 mg | Prevacid | 12/5/2005 |
Non-Orange Book Patents for Tradename: PREVACID
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 Tradename: PREVACID
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 2010132709 | <disabled in preview> | |||||||||||||||||||||||||||
| Taiwan | I257311 | <disabled in preview> | |||||||||||||||||||||||||||
| Japan | 3746167 | <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: PREVACID
| 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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How are People Using DrugPatentWatch?
To research drug patent expirations and NCE dates
— Patent attorney, USA
To identify patents near to expiry
— Pharmaceutical company patent reviewer, Pakistan
To learn about drugs that will be coming off patent and to offer an ANDA in their master drug file
— Global market development manager, healthcare packaging provider, USA
To identify pharmaceutical product patents and process patents, and drug patent expiries
— Global pharmaceutical regulatory affairs, India
To gain knowledge of expiry of patents in anticipation of generic/biosimilars entering the market
— Clinical pharmacist, state drug formulary committee, USA
To gain a view for a new molecules with high market potential
— Strategic business development manager, Poland
For information on patented drugs and their generic versions
— Policy analyst, South Africa
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