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Generated: July 22, 2017
What is the competitive landscape for ABBVIE, and when can generic versions of ABBVIE drugs launch?
ABBVIE has eighty-eight approved drugs.| Patents: | 86 |
| Tradenames: | 77 |
| Ingredients: | 64 |
| NDAs: | 88 |
| 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 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbvie | HARMONYL | deserpidine | TABLET;ORAL | 010796-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Abbvie | KALETRA | lopinavir; ritonavir | SOLUTION;ORAL | 021251-001 | Sep 15, 2000 | AA | RX | Yes | Yes | 6,911,214*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Abbvie Inc | DUOPA | carbidopa; levodopa | SUSPENSION;ENTERAL | 203952-001 | Jan 9, 2015 | RX | Yes | Yes | ► Subscribe | ► Subscribe | |||||||||||||||||||
Abbvie Endocrine Inc | LUPRON DEPOT-PED | leuprolide acetate | INJECTABLE;INJECTION | 020263-006 | Jan 21, 1994 | RX | Yes | Yes | 6,036,976 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Abbvie | ANDROGEL | testosterone | GEL;TRANSDERMAL | 021015-001 | Feb 28, 2000 | AB1 | RX | Yes | No | 9,125,816*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 019732-001 | Jan 26, 1989 | 5,631,020 | ► Subscribe | ||||||||||||||||||||||
Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-001 | Aug 4, 2000 | 4,913,906*PED | ► Subscribe | ||||||||||||||||||||||
Abbvie | KALETRA | lopinavir; ritonavir | CAPSULE;ORAL | 021226-001 | Sep 15, 2000 | 5,948,436*PED | ► Subscribe | ||||||||||||||||||||||
Abbvie | VICOPROFEN | hydrocodone bitartrate; ibuprofen | TABLET;ORAL | 020716-001 | Sep 23, 1997 | 6,348,216 | ► Subscribe | ||||||||||||||||||||||
Abbvie | NUROMAX | doxacurium chloride | INJECTABLE;INJECTION | 019946-001 | Mar 7, 1991 | 4,701,460 | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
lopinavir and ritonavir | Oral Solution | 80 mg/20 mg per mL | KALETRA | 6/19/2014 |
testosterone | Gel | 1.62% (1.25 g and 2.5 g packets) | ANDROGEL | 6/19/2013 |
ritonavir | Capsules | 100 mg | NORVIR | 10/31/2012 |
testosterone | Gel | 1.62% | ANDROGEL | 4/6/2012 |
ritonavir | Tablets | 100 mg | NORVIR | 12/21/2010 |
clarithromycin | Extended-release Tablet | 500 mg | BIAXIN XL | 12/6/2010 |
eprosartan mesylate | Tablets | 400 mg and 600 mg | TEVETEN | 5/10/2010 |
fenofibrate choline | Delayed-release Capsules | 45 mg | TRILIPIX | 9/2/2009 |
fenofibrate choline | Delayed-release Capsules | 135 mg | TRILIPIX | 9/1/2009 |
cisatracurium besylate (multi-dose) | Injection | 2 mg/mL, 10 mL vial | NIMBEX | 8/12/2009 |
cisatracurium besylate (preserve free) | Injection | 2 mg/mL, 5 mL vial and 10 mg/mL, 20 mL vial | NIMBEX | 8/4/2009 |
lopinavir and ritonavir | Tablets | 100 mg/25 mg | KALETRA | 12/23/2008 |
testosterone | Gel Metered-dose Pump | 1% | ANDROGEL | 12/19/2008 |
paricalcitol | Injection | 0.002 mg per mL in 1 mL vial and 0.005 mg per mL in 1 mL and 2 mL vials | ZEMPLAR | 11/28/2008 |
paricalcitol | Capsules | 1 mcg and 2 mcg | ZEMPLAR | 10/14/2008 |
paricalcitol | Capsules | 4 mcg | ZEMPLAR | 8/25/2008 |
fenofibrate | Tablets | 48 mg | TRICOR | 7/1/2008 |
trandolapril and verapamil hydrochloride | Extended-release Tablets | 1 mg/240 mg | TARKA | 2/20/2008 |
trandolapril and verapamil hydrochloride | Extended-release Tablets | 2 mg/180 mg and 2 mg/240 mg | TARKA | 11/9/2007 |
fenofibrate | Tablets | 145 mg | TRICOR | 10/19/2007 |
trandolapril and verapamil hydrochloride | Extended-release Tablets | 4 mg/ 240 mg | TARKA | 7/24/2007 |
hydrocodone bitartrate and ibuprofen | Tablets | 2.5 mg/200 mg | VICOPROFEN | 2/24/2006 |
hydrocodone bitartrate and ibuprofen | Tablets | 5 mg/200 mg | VICOPROFEN | 5/27/2005 |
divalproex sodium | Extended-release Tablets | 500 mg | DEPAKOTE ER | 2/8/2005 |
trandolapril | Tablets | 1 mg, 2 mg and 4 mg | MAVIK | 10/4/2004 |
divalproex sodium | Extended-release Tablets | 250 mg | DEPAKOTE ER | 5/3/2004 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,011,848 | Hydrophobic component free sustained release nicotinic acid compositions for treating hyperlipidemia and related methods therefor | ► Subscribe | |||||||||||||||||||||||||||
| 7,850,995 | Bioadhesive nanoparticulate compositions having cationic surface stabilizers | ► Subscribe | |||||||||||||||||||||||||||
| 6,313,296 | Retroviral protease inhibiting compounds | ► Subscribe | |||||||||||||||||||||||||||
| 8,323,641 | Nanoparticulate compositions having lysozyme as a surface stabilizer | ► Subscribe | |||||||||||||||||||||||||||
| 7,198,795 | In vitro methods for evaluating the in vivo effectiveness of dosage forms of microparticulate of nanoparticulate active agent compositions | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Poland | 366117 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 156236 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 20050026705 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1217993 | ► Subscribe | |||||||||||||||||||||||||||
| Georgia, Republic of | P20105083 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0108 | Belgium | ► Subscribe | PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522 | ||||||||||||||||||||||||||
| C/GB00/010 | United Kingdom | ► Subscribe | PRODUCT NAME: EPROSARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT INCLUDING EPROSARTAN MESYLATE; REGISTERED: DE 39 573.00.00 19970417; DE 39 573.01.00 19970417; DE 39 573.02.00 19970417; UK PL00512/0162 19990823; UK PL00512/0163 19990823; UK PL00512/0164 19990823 | ||||||||||||||||||||||||||
| 2015 00014 | Denmark | ► Subscribe | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119 | ||||||||||||||||||||||||||
| 13/044 | Ireland | ► Subscribe | PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322 | ||||||||||||||||||||||||||
| 2368890/01 | Switzerland | ► Subscribe | PRODUCT NAME: OMBITASVIR; REGISTRATION NO/DATE: SWISSMEDIC 65301 25.11.2014 | ||||||||||||||||||||||||||
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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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