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Generated: August 17, 2017
What is the competitive landscape for NOVARTIS PHARMS, and what generic alternatives to NOVARTIS PHARMS drugs are available?
NOVARTIS PHARMS has seventy approved drugs.| Patents: | 118 |
| Tradenames: | 60 |
| Ingredients: | 50 |
| NDAs: | 70 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis Pharms Corp | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-002 | Nov 20, 2008 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Novartis Pharms Corp | ENTRESTO | sacubitril; valsartan | TABLET;ORAL | 207620-003 | Jul 7, 2015 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Novartis Pharms Corp | SIGNIFOR LAR | pasireotide pamoate | POWDER;INTRAMUSCULAR | 203255-001 | Dec 15, 2014 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Novartis Pharms Corp | PATANASE | olopatadine hydrochloride | SPRAY, METERED;NASAL | 021861-001 | Apr 15, 2008 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Novartis Pharms Corp | PATANOL | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 020688-001 | Dec 18, 1996 | AT | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis Pharms Corp | ZOFRAN | ondansetron hydrochloride | INJECTABLE;INJECTION | 020007-001 | Jan 4, 1991 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novartis Pharms Corp | ZOFRAN | ondansetron hydrochloride | TABLET;ORAL | 020103-001 | Dec 31, 1992 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novartis Pharms Corp | ZOFRAN ODT | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 020781-001 | Jan 27, 1999 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novartis Pharms Corp | XTORO | finafloxacin | SUSPENSION/DROPS;OTIC | 206307-001 | Dec 17, 2014 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novartis Pharms Corp | IOPIDINE | apraclonidine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 019779-001 | Dec 31, 1987 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
travoprost | Ophthalmic Solution | 0.003% | IZBA | 12/30/2015 |
nepafenac | Ophthalmic Suspension | 0.3% | ILEVRO | 12/21/2015 |
deferasirox | Tablets | 180 mg | JADENU | 10/23/2015 |
deferasirox | Tablets | 90 mg and 360 mg | JADENU | 10/19/2015 |
olopatadine hydrochloride | Ophthalmic Solution | 0.7% | PAZEO | 9/10/2015 |
difluprednate | Ophthalmic Emulsion | 0.05% | DUREZOL | 5/1/2014 |
eltrombopag olamine | Tablets | 12.5 mg and 25 mg | PROMACTA | 2/4/2014 |
eltrombopag olamine | Tablets | 50 mg and 75 mg | PROMACTA | 1/7/2014 |
ciprofloxacin and dexamethasone | Otic Suspension | 0.3%/0.1% | CIPRODEX | 7/31/2012 |
moxifloxacin hydrochloride | Ophthalmic Solution | 10.5% | MOXEZA | 2/29/2012 |
argatroban in sodium chloride | Injection | 1 mg/mL, 50 mL vials | ARGATROBAN | 12/16/2011 |
lapatinib ditosylate | Tablets | 250 mg | TYKERB | 3/14/2011 |
olopatadine hydrochloride | Nasal Spray | 0.665 mg/ Spray | PATANASE | 6/29/2009 |
tobramycin | Inhalation Solution | 300 mg/5 mL | TOBI | 6/29/2009 |
travoprost (preserved) | Ophthalmic Solution | 0.00% | TRAVATAN Z | 2/19/2009 |
olopatadine hydrochloride | Ophthalmic Solution | 0.20% | PATADAY | 9/8/2008 |
argatroban | Injection | 100 mg/mL, 2.5 mL vials | ARGATROBAN | 9/24/2007 |
olopatadine hydrochloride | Ophthalmic Solution | 0.10% | PATANOL | 7/17/2006 |
letrozole | Tablets | 2.5 mg | FEMARA | 3/2/2006 |
moxifloxacin hydrochloride | Ophthalmic | 0.50% | VIGAMOX | 12/22/2005 |
ondansetron hydrochloride | Oral Solution | 4 mg/5 mL | ZOFRAN | 12/20/2004 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,445,479 | Staurosporine derivatives as inhibitors of FLT3 receptor tyrosine kinase activity | ► Subscribe | |||||||||||||||||||||||||||
| 6,583,124 | Ophthalmic compositions containing galactomannan polymers and borate | ► Subscribe | |||||||||||||||||||||||||||
| 7,709,012 | Ophthalmic compositions containing a synergistic combination of two polymers | ► Subscribe | |||||||||||||||||||||||||||
| 7,589,200 | 5-Fluoro-4N-phenyl-4-pyrimidineamine compounds | ► Subscribe | |||||||||||||||||||||||||||
| 8,952,018 | Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Taiwan | I333492 | ► Subscribe | |||||||||||||||||||||||||||
| China | 101616895 | ► Subscribe | |||||||||||||||||||||||||||
| Brazil | 0213739 | ► Subscribe | |||||||||||||||||||||||||||
| Austria | 393782 | ► Subscribe | |||||||||||||||||||||||||||
| Cyprus | 1117079 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7 5020-2015 | Slovakia | ► Subscribe | PRODUCT NAME: CERITINIB; REGISTRATION NO/DATE: EU/1/15/999 20150508 | ||||||||||||||||||||||||||
| 37/2008 | Austria | ► Subscribe | PRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON | ||||||||||||||||||||||||||
| 0811 | Netherlands | ► Subscribe | PRODUCT NAME: SACUBITRIL/VALSARTAN, MET INBEGRIP VAN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/15/1058 (C(2015) 8288) 20151123 | ||||||||||||||||||||||||||
| 9 | Finland | ► Subscribe | |||||||||||||||||||||||||||
| 074 | Luxembourg | ► Subscribe | PRODUCT NAME: SACUBITRIL/VALSARTAN, Y COMPRIS LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; FIRST REGISTRATION DATE: 20151123 | ||||||||||||||||||||||||||
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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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