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Generated: August 16, 2017
What is the competitive landscape for LUPIN, and what generic alternatives to LUPIN drugs are available?
LUPIN has one hundred and forty-nine approved drugs.| Patents: | 5 |
| Tradenames: | 117 |
| Ingredients: | 100 |
| NDAs: | 149 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lupin Ltd | POTASSIUM CHLORIDE | potassium chloride | CAPSULE, EXTENDED RELEASE;ORAL | 203002-002 | Dec 18, 2015 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Lupin Ltd | QUININE SULFATE | quinine sulfate | CAPSULE;ORAL | 203112-001 | Apr 24, 2015 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Lupin Ltd | LEVONORGESTREL AND ETHINYL ESTRADIOL | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 091425-001 | Jan 18, 2013 | AB1 | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Lupin Pharms | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 078466-004 | Feb 5, 2010 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Lupin Ltd | ZOLPIDEM TARTRATE | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 078970-002 | Sep 11, 2013 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lupin Atlantis | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-001 | Nov 30, 2004 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Lupin Atlantis | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-002 | Nov 30, 2004 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Lupin Atlantis | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-003 | Nov 30, 2004 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
omeprazole | Delayed-release Tablets | 20 mg | OMEPRAZOLE | 6/3/2015 |
cefixime | for Oral Suspension | 500 mg/5 mL | SUPRAX | 7/22/2014 |
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 | ► Subscribe | |||||||||||||||||||||||||||
| 9,241,905 | Pharmaceutical compositions of Cefixime | ► Subscribe | |||||||||||||||||||||||||||
| 8,658,212 | Pharmaceutical composition containing fenofibrate and method for the preparation thereof | ► Subscribe | |||||||||||||||||||||||||||
| 8,563,042 | Pharmaceutical composition containing fenofibrate and method for the preparation thereof | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2005032526 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2003504331 | ► Subscribe | |||||||||||||||||||||||||||
| Hong Kong | 1084895 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 1574214 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 101150235 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 00499 | Netherlands | ► Subscribe | PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114 | ||||||||||||||||||||||||||
| /2012 | Austria | ► Subscribe | PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124 | ||||||||||||||||||||||||||
| /1998 | Austria | ► Subscribe | PRODUCT NAME: ''IRBESARTAN'' UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE; NAT. REGISTRATION NO/DATE: EU/1/97/046/001 - EU/1/97/046/009 19970827; FIRST REGISTRATION: LI 5425002 19970815 | ||||||||||||||||||||||||||
| C0050 | France | ► Subscribe | PRODUCT NAME: VALSARTAN; REGISTRATION NO/DATE IN FRANCE: NL 22077 DU 19970321; REGISTRATION NO/DATE AT EEC: 369830000 DU 19960513 | ||||||||||||||||||||||||||
| C0030 | France | ► Subscribe | PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607 | ||||||||||||||||||||||||||
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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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