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Generated: August 21, 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 | KALETRA | lopinavir; ritonavir | TABLET;ORAL | 021906-001 | Oct 28, 2005 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Abbvie | TEVETEN HCT | eprosartan mesylate; hydrochlorothiazide | TABLET;ORAL | 021268-001 | Nov 1, 2001 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Abbvie | TEVETEN HCT | eprosartan mesylate; hydrochlorothiazide | TABLET;ORAL | 021268-002 | Nov 1, 2001 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Abbvie | KALETRA | lopinavir; ritonavir | TABLET;ORAL | 021906-002 | Nov 9, 2007 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Abbvie Inc | VIEKIRA XR | dasabuvir sodium; ombitasvir; paritaprevir; ritonavir | TABLET, EXTENDED RELEASE;ORAL | 208624-001 | Jul 22, 2016 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbvie | DEPAKOTE ER | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 021168-001 | Aug 4, 2000 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Abbvie | NORVIR | ritonavir | SOLUTION;ORAL | 020659-001 | Mar 1, 1996 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Abbvie | ZEMPLAR | paricalcitol | CAPSULE;ORAL | 021606-003 | May 26, 2005 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Abbvie | KALETRA | lopinavir; ritonavir | TABLET;ORAL | 021906-001 | Oct 28, 2005 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020517-002 | May 30, 1997 | ► Subscribe | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,428,814 | Bioadhesive nanoparticulate compositions having cationic surface stabilizers | ► Subscribe | |||||||||||||||||||||||||||
| 6,818,229 | Intermediate release nicotinic acid compositions for treating hyperlipidemia | ► Subscribe | |||||||||||||||||||||||||||
| 9,452,194 | Methods for treating HCV | ► Subscribe | |||||||||||||||||||||||||||
| 8,333,990 | Solid pharmaceutical dosage form | ► Subscribe | |||||||||||||||||||||||||||
| 9,586,978 | Anti-viral compounds | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brazil | 0210561 | ► Subscribe | |||||||||||||||||||||||||||
| Poland | 334477 | ► Subscribe | |||||||||||||||||||||||||||
| Eurasian Patent Organization | 200401210 | ► Subscribe | |||||||||||||||||||||||||||
| Hong Kong | 1117417 | ► Subscribe | |||||||||||||||||||||||||||
| Portugal | 1315502 | ► 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.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0030 | France | ► Subscribe | PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607 | ||||||||||||||||||||||||||
| /2000 | Austria | ► Subscribe | PRODUCT NAME: EPROSARTAN, AUCH IN FORM PHARMAZEUTISCH VERTRAEGLICHER SALZE WIE EPROSARTAN MESYLAT; NAT. REGISTRATION NO/DATE: 1-22115, 1-22114, 1-22117 19970930; FIRST REGISTRATION: DE 39573.00.00 - 39573.02.00 19970417 | ||||||||||||||||||||||||||
| C/GB98/031 | United Kingdom | ► Subscribe | PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412 | ||||||||||||||||||||||||||
| 0150015 00143 | Estonia | ► Subscribe | PRODUCT NAME: DASABUVIIR;REG NO/DATE: EU/1/14/983 19.01.2015 | ||||||||||||||||||||||||||
| C/GB08/020 | United Kingdom | ► Subscribe | SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/020 GRANTED TO ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. IN RESPECT OF THE PRODUCT RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6346 DATED 05 JANUARY 2011 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 01 JANUARY 2023. | ||||||||||||||||||||||||||
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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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