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Serving 500+ biopharmaceutical companies globally:

McKinsey
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Generated: June 25, 2017

DrugPatentWatch Database Preview

Ritonavir - Generic Drug Details

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What are the generic sources for ritonavir and what is the scope of ritonavir patent protection?

Ritonavir
is the generic ingredient in two branded drugs marketed by Abbvie, West-ward Pharms Int, and Abbott, and is included in five NDAs. There are twelve patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ritonavir has seventy-one patent family members in thirty-one countries.

There are twenty-one drug master file entries for ritonavir. Four suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for Generic Name: ritonavir

Tradenames:2
Patents:12
Applicants:3
NDAs:5
Drug Master File Entries: see list21
Suppliers / Packagers: see list4
Bulk Api Vendors: see list60
Clinical Trials: see list789
Patent Applications: see list5,123
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ritonavir at DailyMed

Tentative approvals for RITONAVIR

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe100MGTABLET;ORAL
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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
West-ward Pharms Int
RITONAVIR
ritonavir
TABLET;ORAL202573-001Jan 15, 2015ABRXNoNo► Subscribe► Subscribe
Abbvie
NORVIR
ritonavir
CAPSULE;ORAL020945-001Jun 29, 1999RXYesYes6,703,403*PED► Subscribe ► Subscribe
Abbvie
NORVIR
ritonavir
CAPSULE;ORAL020945-001Jun 29, 1999RXYesYes6,037,157*PED► Subscribe ► Subscribe
Abbvie
NORVIR
ritonavir
TABLET;ORAL022417-001Feb 10, 2010ABRXYesYes8,470,347*PED► SubscribeY► Subscribe
Abbvie
NORVIR
ritonavir
CAPSULE;ORAL020945-001Jun 29, 1999RXYesYes7,141,593*PED► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ritonavir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie
NORVIR
ritonavir
TABLET;ORAL022417-001Feb 10, 20105,674,882*PED► Subscribe
Abbvie
NORVIR
ritonavir
CAPSULE;ORAL020945-001Jun 29, 19996,703,403*PED► Subscribe
Abbvie
NORVIR
ritonavir
SOLUTION;ORAL020659-001Mar 1, 19966,703,403*PED► Subscribe
Abbvie
NORVIR
ritonavir
SOLUTION;ORAL020659-001Mar 1, 19965,948,436*PED► Subscribe
Abbvie
NORVIR
ritonavir
SOLUTION;ORAL020659-001Mar 1, 19965,635,523*PED► Subscribe
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Non-Orange Book Patents for Generic Ingredient: ritonavir

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
8,193,367Polymorph of a pharmaceutical► Subscribe
6,458,818 Pharmaceutical composition► Subscribe
9,255,092Polymorph of a pharmaceutical► Subscribe
8,025,899Solid pharmaceutical dosage form► Subscribe
6,894,171 Polymorph of a pharmaceutical► 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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International Patent Family for Ingredient: ritonavir

Country Document Number Estimated Expiration
Portugal871465► Subscribe
European Patent Office0871465► Subscribe
Japan4023823► Subscribe
Brazil122012031169► Subscribe
European Patent Office1210941► 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 Certificates for Tradename: RITONAVIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB01/044United Kingdom► SubscribePRODUCT NAME: THE COMBINATION OF THE ACTIVE INGREDIENTS RITONAVIR AND LOPINAVIR; REGISTERED: CH 55649 20001213; UK EU/1/01/172/001 20010320; UK EU/1/01/172/002 20010320; UK EU/1/01/172/003 20010320
00060Netherlands► SubscribePRODUCT NAME: RITONAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF EEN FARMACEUTISCH AANVAARDBARE ESTER, EN LOPINAVIR; REGISTRATION NO/DATE: EU/1/01/172/001 - EU/1/01/172/003 20010320
0674513Switzerland► SubscribePRODUCT NAME: LOPINAVIR UND RITONAVIR; REGISTRATION NO/DATE: IKS 55648 20001213
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Argus Health
McKesson
Teva
Johnson and Johnson
Cipla
Daiichi Sankyo
Fish and Richardson
Covington
Moodys
UBS

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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