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Generated: August 19, 2017
What is the competitive landscape for LUPIN LTD, and when can generic versions of LUPIN LTD drugs launch?
LUPIN LTD has one hundred and one approved drugs.| Patents: | 1 |
| Tradenames: | 83 |
| Ingredients: | 69 |
| NDAs: | 101 |
| Drug Master File Entries: (click here to view) | 182 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lupin Ltd | RABEPRAZOLE SODIUM | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 078964-001 | Nov 8, 2013 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Lupin Ltd | ZOLPIDEM TARTRATE | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 078970-001 | Sep 11, 2013 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Lupin Ltd | SUPRAX | cefixime | CAPSULE;ORAL | 203195-001 | Jun 1, 2012 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Lupin Ltd | AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 200797-004 | Jun 3, 2015 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Lupin Ltd | AZITHROMYCIN | azithromycin | TABLET;ORAL | 065398-001 | May 15, 2015 | AB | RX | No | No | ► Subscribe | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,241,905 | Pharmaceutical compositions of Cefixime | ► 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) | 2007119249 | ► Subscribe | |||||||||||||||||||||||||||
| Germany | 112007000920 | ► 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.
Export unavailable in trial.
Subscribe for complete access.
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0009 | Belgium | ► Subscribe | PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015 | ||||||||||||||||||||||||||
| C0001 | France | ► Subscribe | PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804 | ||||||||||||||||||||||||||
| 0677 | Netherlands | ► Subscribe | PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121 | ||||||||||||||||||||||||||
| C/GB99/008 | United Kingdom | ► Subscribe | PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015 | ||||||||||||||||||||||||||
| 00133 | Netherlands | ► Subscribe | PRODUCT NAME: OLMESARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN DE CARBOXYGROEP GEKOZEN UIT DE VOLGENDE : EEN ALKYLGROEP 1-4 KOOLSTOFATOMEN, EEN BENZYLGROEP, EEN ALKANOYLOXYALKYLGROEP WAARIN HET ALKANOYLDEEL 1-5; NATL. REGISTRATION NO/DATE: RVG 28785-RVG 28787 20030527; FIRST REGISTRATION: DE 502.02.00.00,502.02.01.00, 502.02.02.00 20020813 | ||||||||||||||||||||||||||
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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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