Lenacapavir
Licensing pipeline · Long-acting injection (subcutaneous) · 463.5 mg / 1.5 mL
Licensing pipelineUS DMF Type II (in preparation)Confidentiality：Highly confidential
- INN / Generic Name
- Lenacapavir
- Dosage Form
- Long-acting injection (subcutaneous)
- Strength
- 463.5 mg / 1.5 mL
- Therapy Area
- Antivirals
- Indication
- HIV-1 infection (multidrug-resistant, long-acting regimen)
- Current Status
- Originator marketed; generic / licensing pipeline in progress (within patent term)
- GMP Certification
- cGMP (in-house facility)
- CEP
- No
- DMF Type
- US DMF Type II (in preparation)
- Stability Data
- 24 months
- BE Required
- Not required / waivable
- Registration Pathway
- NP (post-patent) / voluntary licensing
- MOQ
- 1 project
- Lead Time
- 180 days
- Price Range
- Licensing upfront US$ 800k-1.6M
HS Code
— Not a physical good (target / code name / technical service); no customs code applies.
Registrable Markets
BrazilMoroccoVietnamPeru
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