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Generated: August 18, 2017
What is the competitive landscape for VALEANT, and when can generic versions of VALEANT drugs launch?
VALEANT has one hundred and twenty-five approved drugs.| Patents: | 47 |
| Tradenames: | 102 |
| Ingredients: | 80 |
| NDAs: | 125 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Valeant Pharm Intl | FLUOXYMESTERONE | fluoxymesterone | TABLET;ORAL | 088221-001 | May 5, 1983 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Valeant Intl | CARDIZEM | diltiazem hydrochloride | TABLET;ORAL | 018602-002 | Nov 5, 1982 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Valeant Intl | CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392-003 | Feb 6, 2003 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Valeant Pharms North | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-002 | Apr 23, 2008 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Valeant Pharms Intl | GIAZO | balsalazide disodium | TABLET;ORAL | 022205-001 | Feb 3, 2012 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Valeant Intl | CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062-003 | Dec 27, 1991 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Valeant Intl | CARDIZEM | diltiazem hydrochloride | TABLET;ORAL | 018602-004 | Dec 8, 1986 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Valeant Luxembourg | VISUDYNE | verteporfin | INJECTABLE;INJECTION | 021119-001 | Apr 12, 2000 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Valeant Pharms | MAXAIR | pirbuterol acetate | AEROSOL, METERED;INHALATION | 019009-001 | Dec 30, 1986 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Valeant Intl | VASERETIC | enalapril maleate; hydrochlorothiazide | TABLET;ORAL | 019221-001 | Oct 31, 1986 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
ribavirin | For Inhalation Solution | 6 gm/vial | VIRAZOLE | 5/22/2014 |
balsalazide disodium | Tablets | 1.1 g | GIAZO | 11/5/2013 |
budesonide | Extended-release Tablets | 9 mg | UCERIS | 3/11/2013 |
mesalamine | Extended-release Capsules | 0.375 g | APRISO | 4/3/2012 |
fluorouracil | Cream | 0.5% | CARAC | 7/29/2011 |
bexarotene | Capsules | 75 mg | TARGRETIN | 6/6/2011 |
tretinoin | Gel | 0.04% | RETIN-A MICRO | 12/20/2010 |
tretinoin | Gel | 0.1% | RETIN-A MICRO | 7/8/2010 |
bupropion hydrobromide | Extended-release Tablets | 522 mg | APLENZIN | 12/24/2009 |
bupropion hydrobromide | Extended-release Tablets | 174 mg | APLENZIN | 9/28/2009 |
bupropion hydrobromide | Extended-release Tablets | 348 mg | APLENZIN | 9/24/2009 |
diazepam | Rectal Gel | 5 mg/mL, 2mL pre-filled syringe | DIASTAT ACUDIAL | 12/23/2008 |
diazepam | Rectal Gel | 5 mg/mL, 4mL pre-filled syringe | DIASTAT ACUDIAL | 12/8/2008 |
tramadol hydrochloride | Extended-release Tablets | 300 mg | ULTRAM ER | 9/25/2007 |
tramadol hydrochloride | Extended-release Tablets | 200 mg | ULTRAM ER | 3/28/2007 |
tramadol hydrochloride | Extended-release Tablets | 100 mg | ULTRAM ER | 1/8/2007 |
diltiazem hydrochloride | Extended-release Tablets | 120 mg, 180 mg, 240 mg, 300 mg and 360 mg | CARDIZEM LA | 8/30/2005 |
diltiazem hydrochloride | Extended-release Tablets | 420 mg | CARDIZEM LA | 4/25/2005 |
bupropion hydrochloride | Extended-release Tablets | 150 mg and 300 mg | WELLBUTRIN XL | 9/21/2004 |
diazepam | Rectal Gel | 2.5 mg/0.5 mL, 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL and 20 mg/4 mL | DIASTAT | 3/23/2004 |
| Patent Number | Expiration Date |
|---|---|
| ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5,723,594 | High affinity PDGF nucleic acid ligands | ► Subscribe | |||||||||||||||||||||||||||
| 5,629,155 | High-affinity oligonucleotide ligands to immunoglobulin E (IgE) | ► Subscribe | |||||||||||||||||||||||||||
| 5,879,716 | Methods and compositions for topical delivery of benzoyl peroxide | ► Subscribe | |||||||||||||||||||||||||||
| 6,110,900 | Nucleic acid ligands | ► Subscribe | |||||||||||||||||||||||||||
| 7,005,260 | Tenascin-C nucleic acid ligands | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Germany | 69942485 | ► Subscribe | |||||||||||||||||||||||||||
| Germany | 69735292 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1685842 | ► Subscribe | |||||||||||||||||||||||||||
| Germany | 19732903 | ► Subscribe | |||||||||||||||||||||||||||
| Italy | MI991317 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1458369/01 | Switzerland | ► Subscribe | PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009 | ||||||||||||||||||||||||||
| /2001 | Austria | ► Subscribe | PRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011 | ||||||||||||||||||||||||||
| C/GB02/033 | United Kingdom | ► Subscribe | PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515 | ||||||||||||||||||||||||||
| C/GB05/029 | United Kingdom | ► Subscribe | PRODUCT NAME: MESOTRIONE (2-(4-METHYLSULPHONYL-2-NITROBENZOYL)-1,3CYCLOHEXANEDIONE); REGISTERED: AU 2726 20001016; UK 0309 OF 2005 20050218 | ||||||||||||||||||||||||||
| 1304992/01 | Switzerland | ► Subscribe | PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014 | ||||||||||||||||||||||||||
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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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