Serving 500+ biopharmaceutical companies globally:
Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing
Serving 500+ biopharmaceutical companies globally:
Generated: August 20, 2017
What is the competitive landscape for NOVARTIS, and when can generic versions of NOVARTIS drugs launch?
NOVARTIS has two hundred and thirty-six approved drugs.| Patents: | 192 |
| Tradenames: | 195 |
| Ingredients: | 164 |
| NDAs: | 236 |
| Drug Master File Entries: (click here to view) | 1 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | TYZEKA | telbivudine | TABLET;ORAL | 022011-001 | Oct 25, 2006 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Novartis Pharms Corp | MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114-003 | May 29, 2013 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Novartis Pharms Corp | SIGNIFOR LAR | pasireotide pamoate | POWDER;INTRAMUSCULAR | 203255-003 | Dec 15, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-002 | Jun 20, 2007 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Novartis | SERPASIL | reserpine | TABLET;ORAL | 009115-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis Pharms Corp | ZOFRAN ODT | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 020781-001 | Jan 27, 1999 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novartis | TRANSDERM-NITRO | nitroglycerin | FILM, EXTENDED RELEASE;TRANSDERMAL | 020144-004 | Feb 27, 1996 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novartis | DESFERAL | deferoxamine mesylate | INJECTABLE;INJECTION | 016267-001 | Approved Prior to Jan 1, 1982 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novartis | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-001 | May 26, 2005 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novartis | VIVELLE | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020323-004 | Oct 28, 1994 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
everolimus | Tablets for Oral Suspension | 2 mg, 3 mg and 5 mg | AFINITOR DISPERZ | 12/30/2016 |
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 |
everolimus | Tablets | 2.5 mg, 5 mg, and 7.5 mg | AFINITOR | 12/10/2014 |
fingolimod | Capsules | 0.5 mg | GILENYA | 9/22/2014 |
everolimus | Tablets | 10 mg | AFINITOR | 6/18/2014 |
difluprednate | Ophthalmic Emulsion | 0.05% | DUREZOL | 5/1/2014 |
eltrombopag olamine | Tablets | 12.5 mg and 25 mg | PROMACTA | 2/4/2014 |
imatinib mesylate | Capsules | 400 mg | GLEEVEC | 1/24/2014 |
eltrombopag olamine | Tablets | 50 mg and 75 mg | PROMACTA | 1/7/2014 |
everolimus | Tablets | 0.25 mg, 0.5 mg, and 0.75 mg | ZORTRESS | 9/30/2013 |
nilotinib | Capsules | 150 mg and 200 mg | TASIGNA | 1/29/2013 |
rivastigmine | Transdermal System Extended-release | 13.3 mg/24 hr | EXELON | 1/22/2013 |
ciprofloxacin and dexamethasone | Otic Suspension | 0.3%/0.1% | CIPRODEX | 7/31/2012 |
moxifloxacin hydrochloride | Ophthalmic Solution | 10.5% | MOXEZA | 2/29/2012 |
zoledronic acid | Injection | 4 mg/100 mg, 100 mL vial | ZOMETA | 1/31/2012 |
argatroban in sodium chloride | Injection | 1 mg/mL, 50 mL vials | ARGATROBAN | 12/16/2011 |
deferasirox | Tablets | 125 mg, 250 mg, and 500 mg | EXJADE | 10/28/2011 |
dexmethylphenidate | Extended-release capsules | 25 mg | FOCALIN XR | 9/30/2011 |
dexmethylphenidate | Extended-release capsules | 35 mg | FOCALIN XR | 9/29/2011 |
lapatinib ditosylate | Tablets | 250 mg | TYKERB | 3/14/2011 |
dexmethyphenidate hydrochloride | Extended-release Capsule | 40 mg | FOCALIN XR | 12/20/2010 |
dexmethylphenidate hydrochloride | Extended-release Capsule | 30 mg | FOCALIN XR | 12/15/2010 |
amlodipine, hydrochlorothiazide and valsartan | Tablets | 10 mg/12.5 mg/160 mg | EXFORGE HCT | 10/22/2009 |
amlodipine, hydrochlorothiazide and valsartan | Tablets | 5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 m | EXFORGE HCT | 9/14/2009 |
olopatadine hydrochloride | Nasal Spray | 0.665 mg/ Spray | PATANASE | 6/29/2009 |
tobramycin | Inhalation Solution | 300 mg/5 mL | TOBI | 6/29/2009 |
mycophenolic acid | Delayed-release Tablets | 180 mg | MYFORTIC | 6/4/2009 |
travoprost (preserved) | Ophthalmic Solution | 0.00% | TRAVATAN Z | 2/19/2009 |
mycophenolic acid | Delayed-release Tablets | 360 mg | MYFORTIC | 2/2/2009 |
olopatadine hydrochloride | Ophthalmic Solution | 0.20% | PATADAY | 9/8/2008 |
zoledronic acid | Injection | 0.05 mg/mL, 100 mL vial | RECLAST | 8/29/2008 |
zoledronic acid | Injection | 0.8 mg (base) /mL | ZOMETA | 6/11/2008 |
fluvastatin | Capsules | 20 mg and 40 mg | LESCOL | 6/4/2008 |
amlodipine besylate and valsartan | Tablets | 5 mg/320 mg | EXFORGE | 11/26/2007 |
amlodipine besylate and valsartan | Tablets | 10 mg/320 mg | EXFORGE | 11/9/2007 |
amlodipine besylate and valsartan | Tablets | 5 mg/160 mg | EXFORGE | 10/22/2007 |
amlodipine besylate and valsartan | Tablets | 10 mg/160 mg | EXFORGE | 10/1/2007 |
argatroban | Injection | 100 mg/mL, 2.5 mL vials | ARGATROBAN | 9/24/2007 |
metformin hydrochloride | Extended-release Capsules | 10 mg | RITALIN LA | 5/21/2007 |
dexmethylphenidate hydrochloride | Extended-release Capsules | 15 mg | FOCALIN XR | 5/14/2007 |
dexmethylphenidate hydrochloride | Extended-release Capsules | 5mg, 10mg and 20 mg | FOCALIN XR | 3/30/2007 |
fluvastatin sodium | Extended-release Tablets | 80 mg | LESCOL XL | 3/15/2007 |
imatinib mesylate | Tablets | 100 mg and 400 mg | GLEEVEC | 3/12/2007 |
valsartan and hydrochlorothiazide | Tablets | 320 mg/12.5 mg and 320 mg/25 mg | DIOVAN HCT | 2/7/2007 |
oxcarbazepine | Oral Suspension | 300 mg/5 mL | TRILEPTAL | 12/26/2006 |
amlodipine besylate and benazepril hydrochloride | Capsules | 5 mg/40 mg and 10 mg/40 mg | LOTREL | 11/17/2006 |
metformin hydrochloride | Extended-release Capsules | 20 mg, 30 mg and 40 mg | RITALIN LA | 8/21/2006 |
olopatadine hydrochloride | Ophthalmic Solution | 0.10% | PATANOL | 7/17/2006 |
oxcarbazepine | Tablets | 150 mg, 300 mg and 600 mg | TRILEPTAL | 5/5/2006 |
letrozole | Tablets | 2.5 mg | FEMARA | 3/2/2006 |
carbamazepine | Extended-release Tablets | 100 mg | TEGRETOL-XR | 12/30/2005 |
moxifloxacin hydrochloride | Ophthalmic | 0.50% | VIGAMOX | 12/22/2005 |
valsartan and hydrochlorothiazide | Tablets | 80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg | DIOVAN HCT | 12/2/2005 |
famciclovir | Tablets | 125 mg, 250 mg and 500 mg | FAMVIR | 12/28/2004 |
valsartan | Tablets | 40 mg, 80 mg,160 mg | DIOVAN | 12/28/2004 |
nateglinide | Tablets | 60 mg and 120 mg | STARLIX | 12/22/2004 |
ondansetron hydrochloride | Oral Solution | 4 mg/5 mL | ZOFRAN | 12/20/2004 |
rivastigmine tartrate | Oral Solution | 2 mg/mL | EXELON | 11/5/2004 |
dexmethylphenidate hydrochloride | Tablets | 2.5 mg | FOCALIN | 7/27/2004 |
amlodipine besylate and benazepril hydrochloride | Capsules | 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg | LOTREL | 6/9/2004 |
dexmethylphenidate hydrochloride | Tablets | 5 mg and 10 mg | FOCALIN | 5/27/2004 |
rivastigmine tartrate | Capsules | 1.5 mg, 3 mg, 4.5 mg and 6 mg | EXELON | 4/21/2004 |
| Patent Number | Expiration Date |
|---|---|
| ► Subscribe | ► Subscribe |
| ► Subscribe | ► Subscribe |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5,952,305 | Methods for reducing risk of repeat myocardial infarction and increasing survival in heart attack victims | ► Subscribe | |||||||||||||||||||||||||||
| 6,309,623 | Stabilized preparations for use in metered dose inhalers | ► Subscribe | |||||||||||||||||||||||||||
| 6,296,872 | Tablet composition of N-(trans-4-isopropylcyclohexanecarbonyl)-D-phenylalanine | ► Subscribe | |||||||||||||||||||||||||||
| 9,023,893 | Synergistic combinations comprising a renin inhibitor for cardiovascular diseases | ► Subscribe | |||||||||||||||||||||||||||
| 6,838,449 | Ophthalmic compositions containing galactomannan polymers and borate | ► Subscribe | |||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
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.
Export unavailable in trial.
Subscribe for complete access.
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Canada | 2147044 | ► Subscribe | |||||||||||||||||||||||||||
| Brazil | 112013015602 | ► Subscribe | |||||||||||||||||||||||||||
| Philippines | 12013501590 | ► Subscribe | |||||||||||||||||||||||||||
| Mexico | PA02012681 | ► Subscribe | |||||||||||||||||||||||||||
| Netherlands | 300248 | ► Subscribe | |||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 07C/043 | Belgium | ► Subscribe | PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222 | ||||||||||||||||||||||||||
| C 035/2006 | Ireland | ► Subscribe | SPC 035/2006: 20070528, EXPIRES: 20210827 | ||||||||||||||||||||||||||
| 0716600/01 | Switzerland | ► Subscribe | PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008 | ||||||||||||||||||||||||||
| 2011010 | Lithuania | ► Subscribe | PRODUCT NAME: FINGOLIMODUM; REGISTRATION NO/DATE: EU/1/11/677/001, 2011 03 17 EU/1/11/677/002, 2011 03 17 EU/1/11/677/003, 2011 03 17 EU/1/11/677/004 20110317 | ||||||||||||||||||||||||||
| 2008 00040 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
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.
Follow DrugPatentWatch:
Join the 22,363 others who get our Drug Patent Expiration Alerts:
