DORAVIRINE - Generic Drug Details
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What are the generic drug sources for doravirine and what is the scope of freedom to operate?
Doravirine
is the generic ingredient in two branded drugs marketed by Msd Merck Co and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Doravirine has seventy-three patent family members in forty-four countries.
Two suppliers are listed for this compound.
Summary for DORAVIRINE
International Patents: | 73 |
US Patents: | 3 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 57 |
Clinical Trials: | 51 |
Patent Applications: | 482 |
Drug Prices: | Drug price trends for DORAVIRINE |
What excipients (inactive ingredients) are in DORAVIRINE? | DORAVIRINE excipients list |
DailyMed Link: | DORAVIRINE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DORAVIRINE
Generic Entry Date for DORAVIRINE*:
Constraining patent/regulatory exclusivity:
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 DORAVIRINE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Insel Gruppe AG, University Hospital Bern | Phase 4 |
University of Bern | Phase 4 |
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland | Phase 4 |
Pharmacology for DORAVIRINE
Drug Class | Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor |
Mechanism of Action | Non-Nucleoside Reverse Transcriptase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for DORAVIRINE
US Patents and Regulatory Information for DORAVIRINE
EU/EMA Drug Approvals for DORAVIRINE
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Merck Sharp & Dohme B.V. | Pifeltro | doravirine | EMEA/H/C/004747 Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with HIV 1 without past or present evidence of resistance to the NNRTI class. |
Authorised | no | no | no | 2018-11-22 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for DORAVIRINE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | 112012024691 | composto, e, composição farmacêutica | ⤷ Try for Free |
Norway | 2019019 | ⤷ Try for Free | |
World Intellectual Property Organization (WIPO) | 2011120133 | ⤷ Try for Free | |
Montenegro | 02181 | NE-NUKLEOZIDNI INHIBITORI REVERZNE TRANSKRIPTAZE (NON-NUCLEOSIDE REVERSE TRANSCRIPT ASE INHIBITORS) | ⤷ Try for Free |
Netherlands | 300980 | ⤷ Try for Free | |
Honduras | 2012002039 | INHIBIDORES NO NUCLEOSIDICOS DE LA TRANSCRIPTASA INVERSA | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DORAVIRINE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2552902 | 2019/020 | Ireland | ⤷ Try for Free | PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/18/1332/001, EU/1/18/1332/002, EU/1/18/1333/001, EU/1/18/1333/002, 20181122 |
2552902 | C20190024 00304 | Estonia | ⤷ Try for Free | PRODUCT NAME: DORAVIRIIN;REG NO/DATE: EU/1/18/1332 27.11.2018 |
2924034 | CR 2019 00024 | Denmark | ⤷ Try for Free | PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND IN COMBINATION WITH TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126 |
2924034 | SPC/GB19/024 | United Kingdom | ⤷ Try for Free | PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL; REGISTERED: UK EU/1/18/1333/001-002 20181122; UK PLGB 5305/0015 20181122 |
2924034 | CA 2019 00024 | Denmark | ⤷ Try for Free | PRODUCT NAME: DORAVIRINE, LAMIVUDINE AND DISOPROXIL; REG. NO/DATE: EU/1/18/1333 20181126 |
2924034 | 25/2019 | Austria | ⤷ Try for Free | PRODUCT NAME: DORAVIRIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON IN KOMBINATION MIT LAMIVUDIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON IN KOMBINATION MIT TENOFOVIR ODER EINEM ESTER DAVON, INSBESONDERE EINEM DISOPROXILESTER ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON, INSBESONDERE EINEM FUMARATSALZ; REGISTRATION NO/DATE: EU/1/18/1333/001-002 (MITTEILUNG) 20181126 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Doravirine
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