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Last Updated: February 25, 2020

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DELSTRIGO Drug Profile


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When do Delstrigo patents expire, and what generic alternatives are available?

Delstrigo is a drug marketed by Msd Merck Co and is included in one NDA. There is one patent protecting this drug.

This drug has sixty-four patent family members in forty countries.

The generic ingredient in DELSTRIGO is doravirine; lamivudine; tenofovir disoproxil fumarate. One supplier is listed for this compound. Additional details are available on the doravirine; lamivudine; tenofovir disoproxil fumarate profile page.

US ANDA Litigation and Generic Entry Outlook for Delstrigo

Delstrigo will be eligible for patent challenges on August 30, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 7, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for DELSTRIGO
International Patents:64
US Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 1
Formulation / Manufacturing:see details
DailyMed Link:DELSTRIGO at DailyMed
Drug patent expirations by year for DELSTRIGO
Generic Entry Opportunity Date for DELSTRIGO
Generic Entry Date for DELSTRIGO*:
Constraining patent/regulatory exclusivity:
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 DELSTRIGO

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

SponsorPhase
Dr. Josep MallolasPhase 4
David Garcia CincaPhase 4

See all DELSTRIGO clinical trials

US Patents and Regulatory Information for DELSTRIGO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Msd Merck Co DELSTRIGO doravirine; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210807-001 Aug 30, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for DELSTRIGO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2924034 2019C/005 Belgium   Start Trial PRODUCT NAME: DORAVIRINE,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT IN COMBINATIE MET LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAARZOUT, IN COMBINATIE MET TENOFOVIR OF EEN ESTER DAARVAN, IN HET BIJZONDER EEN DISOPROXIL ESTER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER EEN FUMARAAT ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/18/1333/001-002 20181126
2924034 PA2019507 Lithuania   Start Trial PRODUCT NAME: DORAVIRINAS ARBA JO DRUSKA, LAMIVUDINAS ARBA JO DRUSKA, TENOFOVIRAS ARBA JO ESTERIS, YPAC DIZOPROKSILO ESTERIS ARBA JO DRUSKA, YPAC FUMARATO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1333 20181122
2552902 122019000038 Germany   Start Trial
2552902 19C1024 France   Start Trial PRODUCT NAME: DORAVIRINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/18/1333 20181126
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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