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: | 49 |
| 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 |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | Phase 4 |
| Merck Sharp & Dohme LLC | Phase 4 |
| Radboud University Medical Center | 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 |
US Patents and Regulatory Information for DORAVIRINE
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Msd Merck Co | DELSTRIGO | doravirine; lamivudine; tenofovir disoproxil fumarate | TABLET;ORAL | 210807-001 | Aug 30, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Msd Merck Co | PIFELTRO | doravirine | TABLET;ORAL | 210806-001 | Aug 30, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Msd Merck Co | DELSTRIGO | doravirine; lamivudine; tenofovir disoproxil fumarate | TABLET;ORAL | 210807-001 | Aug 30, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 |
|---|---|---|---|
| Georgia, Republic of | P20156368 | NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS | ⤷ Try a Trial |
| Montenegro | 02181 | NE-NUKLEOZIDNI INHIBITORI REVERZNE TRANSKRIPTAZE (NON-NUCLEOSIDE REVERSE TRANSCRIPT ASE INHIBITORS) | ⤷ Try a Trial |
| Croatia | P20161680 | ⤷ Try a Trial | |
| Dominican Republic | P2012000256 | INHIBIDORES NO NUCLEOSÍDICOS DE LA TRANSCRIPTASA INVERSA | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DORAVIRINE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2552902 | SPC/GB19/023 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/18/1332/001-002 20181122; UK PLGB 53095/0045 20181122 |
| 2552902 | LUC00113 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: DORAVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1332 20181127 |
| 2924034 | C201930027 | Spain | ⤷ Try a Trial | PRODUCT NAME: DORAVIRINA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA EN COMBINACION CON LAMIVUDINA Y TENOFOVIR DISOPROXILO FUMARATO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1333; DATE OF AUTHORISATION: 20181122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1333; DATE OF FIRST AUTHORISATION IN EEA: 20181122 |
| 2924034 | PA2019507,C2924034 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DORAVIRINAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, DERINYJE SU LAMIVUDINU IR TENOFOVIRO DIZOPROKSILIO FUMARATU; REGISTRATION NO/DATE: EU/1/18/1333 20181122 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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