DrugPatentWatch Database Preview
Lupin Company Profile
What is the competitive landscape for LUPIN, and what generic alternatives to LUPIN drugs are available?
There are five US patents protecting LUPIN drugs. There are sixteen tentative approvals on LUPIN drugs.
There are eighty-five patent family members on LUPIN drugs in thirty-seven countries and two hundred and thirty-four supplementary protection certificates in thirteen countries.
Summary for Lupin
| International Patents: | 85 |
| US Patents: | 5 |
| Tradenames: | 133 |
| Ingredients: | 114 |
| NDAs: | 168 |
| Patent Litigation for Lupin: | See patent lawsuits for Lupin |
| PTAB Cases with Lupin as petitioner: | See PTAB cases with Lupin as petitioner |
Drugs and US Patents for Lupin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lupin | LOVASTATIN | lovastatin | TABLET;ORAL | 078296-002 | Nov 1, 2007 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| Lupin | TOPIRAMATE | topiramate | TABLET;ORAL | 078410-001 | Sep 11, 2013 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| Lupin Ltd | RANOLAZINE | ranolazine | TABLET, EXTENDED RELEASE;ORAL | 201046-002 | Jul 29, 2013 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | |||||
| Lupin Ltd | QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 201109-006 | Mar 27, 2012 | AB | RX | No | No | ➤ 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 Lupin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Lupin Atlantis | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-003 | Nov 30, 2004 | 4,800,079 | ➤ Sign Up |
| Lupin Atlantis | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-001 | Nov 30, 2004 | 4,800,079 | ➤ Sign Up |
| Lupin Atlantis | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-002 | Nov 30, 2004 | 4,800,079 | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for LUPIN drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Delayed-release Tablets | 20 mg | ➤ Subscribe | 2015-06-03 |
| ➤ Subscribe | for Oral Suspension | 500 mg/5 mL | ➤ Subscribe | 2014-07-22 |
Non-Orange Book US Patents for Lupin
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 |
|---|---|---|
| 8,529,952 | Pharmaceutical composition containing fenofibrate and method for the preparation thereof | ➤ Sign Up |
| 9,241,905 | Pharmaceutical compositions of Cefixime | ➤ Sign Up |
| 8,658,212 | Pharmaceutical composition containing fenofibrate and method for the preparation thereof | ➤ Sign Up |
| 8,563,042 | Pharmaceutical composition containing fenofibrate and method for the preparation thereof | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Lupin Drugs
Supplementary Protection Certificates for Lupin Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2008 00035 | Denmark | ➤ Sign Up | PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID |
| 2013 00001 | Denmark | ➤ Sign Up | PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720 |
| 0371 | Netherlands | ➤ Sign Up | PRODUCT NAME: RANOLAZINE OF EEN ZOUT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080714 |
| 636 | Luxembourg | ➤ Sign Up | PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
