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Last Updated: May 26, 2022

PREVYMIS Drug Patent Profile


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Which patents cover Prevymis, and when can generic versions of Prevymis launch?

Prevymis is a drug marketed by Merck Sharp Dohme and is included in two NDAs. There are three patents protecting this drug.

This drug has eighty-three patent family members in forty-five countries.

The generic ingredient in PREVYMIS is letermovir. One supplier is listed for this compound. Additional details are available on the letermovir profile page.

DrugPatentWatch® Generic Entry Outlook for Prevymis

Prevymis was eligible for patent challenges on November 8, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 8, 2024. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for PREVYMIS
International Patents:83
US Patents:3
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 35
Clinical Trials: 5
Patent Applications: 112
Drug Prices: Drug price information for PREVYMIS
What excipients (inactive ingredients) are in PREVYMIS?PREVYMIS excipients list
DailyMed Link:PREVYMIS at DailyMed
Drug patent expirations by year for PREVYMIS
Drug Prices for PREVYMIS

See drug prices for PREVYMIS

DrugPatentWatch® Estimated Generic Entry Opportunity Date for PREVYMIS
Generic Entry Dates for PREVYMIS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS
Generic Entry Dates for PREVYMIS*:
Constraining patent/regulatory exclusivity:
PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN ADULT CMV-SEROPOSITIVE RECIPIENTS [R+] OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT)
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for PREVYMIS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institute of Allergy and Infectious Diseases (NIAID)Phase 2
Fernanda P Silveira, MD, MSPhase 2
Ohio State University Comprehensive Cancer CenterPhase 2

See all PREVYMIS clinical trials

US Patents and Regulatory Information for PREVYMIS

PREVYMIS is protected by three US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PREVYMIS is See Plans and Pricing.

This potential generic entry date is based on PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN ADULT CMV-SEROPOSITIVE RECIPIENTS [R+] OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT).

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting PREVYMIS

Pharmaceutical composition containing an antivirally active dihydroquinazoline derivative
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted dihydroquinazolines
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted dihydroquinazolines
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting PREVYMIS

PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN ADULT CMV-SEROPOSITIVE RECIPIENTS [R+] OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT)
Exclusivity Expiration: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-001 Nov 8, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Merck Sharp Dohme PREVYMIS letermovir TABLET;ORAL 209939-002 Nov 8, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-002 Nov 8, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for PREVYMIS

When does loss-of-exclusivity occur for PREVYMIS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 4078
Estimated Expiration: See Plans and Pricing

Australia

Patent: 04233978
Estimated Expiration: See Plans and Pricing

Patent: 13224947
Estimated Expiration: See Plans and Pricing

Austria

Patent: 5280
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0410029
Estimated Expiration: See Plans and Pricing

Canada

Patent: 24069
Estimated Expiration: See Plans and Pricing

Patent: 65203
Estimated Expiration: See Plans and Pricing

Chile

Patent: 04000930
Estimated Expiration: See Plans and Pricing

Patent: 14002306
Estimated Expiration: See Plans and Pricing

China

Patent: 84390
Estimated Expiration: See Plans and Pricing

Patent: 0393706
Estimated Expiration: See Plans and Pricing

Patent: 4144678
Estimated Expiration: See Plans and Pricing

Patent: 0433166
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 00764
Estimated Expiration: See Plans and Pricing

Patent: 61076
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0191369
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 22880
Estimated Expiration: See Plans and Pricing

Patent: 19648
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 056138
Estimated Expiration: See Plans and Pricing

Egypt

Patent: 273
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 6584
Estimated Expiration: See Plans and Pricing

Patent: 1400963
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 22880
Estimated Expiration: See Plans and Pricing

Patent: 19648
Estimated Expiration: See Plans and Pricing

Patent: 56350
Estimated Expiration: See Plans and Pricing

Germany

Patent: 319612
Estimated Expiration: See Plans and Pricing

Patent: 2012101680
Estimated Expiration: See Plans and Pricing

Patent: 2004003052
Estimated Expiration: See Plans and Pricing

Honduras

Patent: 04000146
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 92463
Estimated Expiration: See Plans and Pricing

Patent: 05462
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 45949
Estimated Expiration: See Plans and Pricing

Patent: 800018
Estimated Expiration: See Plans and Pricing

Patent: 800028
Estimated Expiration: See Plans and Pricing

India

Patent: 92MUN2014
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1513
Estimated Expiration: See Plans and Pricing

Patent: 4363
Estimated Expiration: See Plans and Pricing

Japan

Patent: 33631
Estimated Expiration: See Plans and Pricing

Patent: 87486
Estimated Expiration: See Plans and Pricing

Patent: 06525249
Estimated Expiration: See Plans and Pricing

Patent: 15508801
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 19648
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 4616
Estimated Expiration: See Plans and Pricing

Patent: 2310
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 05011707
Estimated Expiration: See Plans and Pricing

Patent: 9666
Estimated Expiration: See Plans and Pricing

Patent: 14010364
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 448
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 794
Estimated Expiration: See Plans and Pricing

Patent: 941
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 0933
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 3317
Estimated Expiration: See Plans and Pricing

Patent: 8444
Estimated Expiration: See Plans and Pricing

Norway

Patent: 3265
Estimated Expiration: See Plans and Pricing

Patent: 055649
Estimated Expiration: See Plans and Pricing

Peru

Patent: 050145
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 014501937
Estimated Expiration: See Plans and Pricing

Poland

Patent: 22880
Estimated Expiration: See Plans and Pricing

Patent: 19648
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 22880
Estimated Expiration: See Plans and Pricing

Patent: 19648
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 60912
Estimated Expiration: See Plans and Pricing

Patent: 05137276
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 157
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201405294X
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 22880
Estimated Expiration: See Plans and Pricing

Patent: 19648
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0508710
Estimated Expiration: See Plans and Pricing

Patent: 1405949
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 0927063
Estimated Expiration: See Plans and Pricing

Patent: 2149561
Estimated Expiration: See Plans and Pricing

Patent: 060009883
Estimated Expiration: See Plans and Pricing

Patent: 140130683
Estimated Expiration: See Plans and Pricing

Spain

Patent: 84007
Estimated Expiration: See Plans and Pricing

Patent: 41698
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 35912
Estimated Expiration: See Plans and Pricing

Patent: 0510343
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 14000345
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 519
Estimated Expiration: See Plans and Pricing

Patent: 1415
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 294
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PREVYMIS around the world.

Country Patent Number Title Estimated Expiration
Morocco 35941 Préparation pharmaceutique contenant un dérivé de dihydrochinazoline à action antivirale See Plans and Pricing
Croatia P20191369 See Plans and Pricing
Lithuania 2819648 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PREVYMIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1622880 18C1029 France See Plans and Pricing PRODUCT NAME: LETERMOVIR AINSI QUE SES SELS,SOLVATES ET SELS SOLVATES,PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/17/1245/001-004 20180110
1622880 122018000080 Germany See Plans and Pricing PRODUCT NAME: LETERMOVIR ODER DESSEN SALZ, SOLVAT ODER SOLVAT DES SALZES; REGISTRATION NO/DATE: EU/1/17/1245 20180108
1622880 327 50010-2018 Slovakia See Plans and Pricing OWNER(S): AIC246 GMBH&CO. KG, WUPPERTAL, DE; PREVIOUS OWNER: AICURIS ANTI-INFECTIVE CURES GMBH, WUPPERTAL, DE;
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Moodys
Colorcon
Express Scripts
Johnson and Johnson
Dow

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 verification 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.