United States Patent 10,603,282: A Comprehensive Analysis
Introduction
United States Patent 10,603,282, issued on March 31, 2020, is a significant patent in the pharmaceutical sector, particularly in the treatment of HIV infection. This patent, assigned to Merck Sharp & Dohme Corp., details pharmaceutical compositions containing doravirine, tenofovir disoproxil fumarate, and lamivudine.
Inventors and Assignees
The patent was invented by a team of researchers including Panmai Santipharp, Tatavarti Aditya, Farrington Andrew M., Biyyala Varsha, Allain Leonardo R., Nefliu Marcela, Klinzing Gerard R., Ren Jie, and Lamm Matthew. The assignee of this patent is Merck Sharp & Dohme Corp., a major pharmaceutical company[2].
Scope of the Patent
The patent pertains to pharmaceutical compositions that combine doravirine, tenofovir disoproxil fumarate, and lamivudine. These compositions are specifically designed for the treatment of HIV infection. Here’s a breakdown of the key components:
- Doravirine: A non-nucleoside reverse transcriptase inhibitor (NNRTI) that blocks the replication of HIV.
- Tenofovir Disoproxil Fumarate: A nucleotide reverse transcriptase inhibitor (NtRTI) that also inhibits HIV replication.
- Lamivudine: A nucleoside reverse transcriptase inhibitor (NRTI) that is effective against HIV and hepatitis B[2].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
- Composition Claims: The patent claims pharmaceutical compositions that contain specific amounts of doravirine, tenofovir disoproxil fumarate, and lamivudine. These compositions can be in various forms such as tablets, capsules, or other solid dosage forms[1][2].
- Process Claims: The patent also claims processes for making these pharmaceutical compositions, including methods for formulating, manufacturing, and testing the final products[1][2].
Formulation Ingredients
The compositions may include additional formulation ingredients to enhance their stability, bioavailability, and patient compliance. These ingredients can include:
- Diluents: Substances that increase the bulk of the formulation.
- Binders: Substances that hold the formulation together.
- Compression Aids: Substances that help in the compression of the formulation into tablets.
- Disintegrants: Substances that help the tablet disintegrate in the body.
- Lubricants: Substances that reduce friction during the manufacturing process.
- Glidants: Substances that improve the flow of the powder during manufacturing. Colloidal silica is specifically mentioned as a glidant in this class of the invention[1].
Patent Expiration Dates
The patent is set to expire on November 29, 2036. This expiration date is crucial for understanding the timeline during which Merck Sharp & Dohme Corp. holds exclusive rights to these pharmaceutical compositions[2].
Exclusivity Periods
In addition to the patent expiration, the FDA has granted exclusivity periods that can run concurrently with the patent. For this particular drug, the exclusivity period is set to expire on January 27, 2025, for new patient populations[2].
Related Patents and Exclusivities
There are related patents and exclusivities that complement this patent. For example, Patent 10,842,751, also issued to Merck Sharp & Dohme Corp., covers similar pharmaceutical compositions and processes. These related patents and exclusivities help in maintaining a comprehensive intellectual property portfolio for the treatment of HIV infection[2].
Market Impact
The absence of a generic version of Delstrigo, the brand name for the combination of doravirine, tenofovir disoproxil fumarate, and lamivudine, means that Merck Sharp & Dohme Corp. retains a significant market advantage until the patent and exclusivity periods expire. This is particularly important in the HIV treatment market, where brand loyalty and patent protection can significantly influence market share[2].
Conclusion and Key Takeaways
- Patent Scope: The patent covers specific pharmaceutical compositions and processes for treating HIV infection.
- Key Components: Doravirine, tenofovir disoproxil fumarate, and lamivudine.
- Formulation Ingredients: Include diluents, binders, compression aids, disintegrants, lubricants, and glidants.
- Patent Expiration: November 29, 2036.
- Exclusivity Periods: January 27, 2025, for new patient populations.
- Market Impact: Significant market advantage for Merck Sharp & Dohme Corp. until patent and exclusivity periods expire.
FAQs
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What are the main components of the pharmaceutical compositions covered by US Patent 10,603,282?
- The main components are doravirine, tenofovir disoproxil fumarate, and lamivudine.
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Who is the assignee of this patent?
- The assignee is Merck Sharp & Dohme Corp.
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What is the purpose of the pharmaceutical compositions described in this patent?
- The compositions are designed for the treatment of HIV infection.
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When is the patent set to expire?
- The patent is set to expire on November 29, 2036.
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Is there a generic version of Delstrigo available in the United States?
- No, there is currently no therapeutically equivalent generic version of Delstrigo available in the United States[2].
Cited Sources:
- US10603282B2 - Pharmaceutical compositions containing doravirine, tenofovir disoproxil fumarate and lamivudine - Google Patents
- Generic Delstrigo Availability - Drugs.com
- Patent Landscape Reports by Other Organizations - WIPO
- Pharmaceutical compositions containing doravirine, tenofovir ... - PubChem
- US-10842751-B2 - Unified Patents Portal