Aspen Pharmacare

Focus: Aspen Pharmacare is a small-to-mid-cap public biotech focused on small-molecule generics and branded antiretrovirals, headquartered in Brazil with 201–500 employees. The company operates with extreme revenue concentration on a single pre-launch product.

Respiratory

Profile data last refreshed 11h ago · AI intelligence enriched 2w ago

Funding Stage

PUBLIC

Employees

201-500

Open Jobs

About Aspen Pharmacare

AI assessmentNot Hiring

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Generated by Claude from Aspen Pharmacare's SEC filings, pipeline programs, hiring velocity, FDA actions, and WARN data. Inference, not editorial — verify before quoting.

Data completeness

2/9 — Limited

Company HealthSolid

Pipeline

Early-stage

0 total

LOE Risk

Protected

No near-term cliffs

Hiring

0 open

Automated analysis based on publicly available data (FDA, SEC, ClinicalTrials.gov). May be incomplete or delayed. This score does not reflect insider knowledge and should not be used as the sole basis for investment or employment decisions.

Key Products

EFAVIRENZ

HIV-1 infection in combination with other antiretroviral agents

$2M Part D

Pre-Launch

Sole revenue driver (100% of company revenue); fixed-dose combination with emtricitabine and tenofovir disoproxil fumarate; ANDA status.

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

12.1 Mechanism of Action Stavudine is an antiviral drug [see ]. 12.3 Pharmacokinetics The pharmacokinetics of stavudine have been evaluated in HIV-1-infected adult and pediatric patients (, , and ). Peak plasma concentrations (C max ) and area under the plasma concentration-time curve (AUC) increased in proportion to dose after both single and multiple doses ranging from 0.03 to 4 mg/kg. There was no significant accumulation of stavudine with repeated administration every 6, 8, or 12 hours. Absorption Following oral administration, stavudine is rapidly absorbed, with peak plasma concentrations occurring within one hour after dosing. The systemic exposure to stavudine is the same following administration as capsules or solution. Steady-state pharmacokinetic parameters of stavudine in HIV-1-infected adults are shown in Table 7. Table 7: Steady-State Pharmacokinetic Parameters of Stavudine in HIV-1-Infected AUC 0-24 = Area under the curve over 24 hours C max = Maximum plasma concentration C min = Trough or minimum plasma concentration Parameter Stavudine 40 mg BID Mean ± SD (n = 8) AUC 0-24 (ng•h/mL) C max (ng/mL) C min (ng/mL) 2568 ± 454 536 ± 146 8 ± 9 Distribution Binding of stavudine to serum proteins was negligible over the concentration range of 0.01 to 11.4 mcg/mL. Stavudine distributes equally between red blood cells and plasma. Volume of distribution is shown in Table 8. Metabolism Metabolism plays a limited role in the clearance of stavudine. Unchanged stavudine was the major drug-related component circulating in plasma after an 80 mg dose of C-stavudine, while metabolites constituted minor components of the circulating radioactivity. Minor metabolites include oxidized stavudine, glucuronide conjugates of stavudine and its oxidized metabolite, and an N-acetylcysteine conjugate of the ribose after glycosidic cleavage, suggesting that thymine is also a metabolite of stavudine. Elimination Following an 80 mg dose of C-stavudine to healthy subjects, approximately 95% and 3% of the total radioactivity was recovered in urine and feces, respectively. Radioactivity due to parent drug in urine and feces was 73.7% and 62%, respectively. The mean terminal elimination half-life is approximately 2.3 hours following single oral doses. Mean renal clearance of the parent compound is approximately 272 mL/min, accounting for approximately 67% of the apparent oral clearance. In HIV-1-infected patients, renal elimination of unchanged drug accounts for about 40% of the overall clearance regardless of the route of administration (Table 8). The mean renal clearance was about twice the average endogenous creatinine clearance, indicating active tubular secretion in addition to glomerular filtration. Table 8: Pharmacokinetic Parameters of Stavudine in HIV-1-Infected Adults: Bioavailability, Distribution and Clearance Parameter Mean ± SD n Oral bioavailability (%) 86.4 ± 18.2 25 Volume of distribution (L) Following 1-hour IV infusion 46 ± 21 44 Total body clearance (mL/min) 594 ± 164 44 Apparent oral clearance (mL/min) Following single oral dose 560 ± 182 Assuming a body weight of 70 kg 113 Renal clearance (mL/min) 237 ± 98 39 Elimination half-life, IV dose (h) 1.15 ± 0.35 44 Elimination half-life, oral dose (h) 1.6 ± 0.23 8 Urinary recovery of stavudine (% of dose) Over 12 to 24 hours 42 ± 14 39 Special Populations Pediatric Pharmacokinetic properties of stavudine in pediatric patients are presented in Table 9. Table 9: Pharmacokinetic Parameters (Mean ± SD) of Stavudine in HIV-1-Exposed or -Infected Pediatric Patients ND = Not determined. Parameter Ages 5 weeks to 15 years n Ages 14 to 28 days n Day of Birth n Oral bioavailability (%) 76.9 ± 31.7 20 ND ND Volume of distribution (L/kg) Following 1-hour IV infusion. 0.73 ± 0.32 21 ND ND Ratio of CSF:plasma concentrations (as %) At median time of 2.5 hours (range 2 to 3 hours) following multiple oral doses. 59 ± 35 8 ND ND Total body clearance (mL/min/kg) 9.75 ± 3.76 21 ND ND Apparent oral clearance (mL/min/kg) Following single oral dose. 13.75 ± 4.29 20 11.52 ± 5.93 30 5.08 ± 2.80 17 Elimination half-life, IV dose (h) 1.11 ± 0.28 21 ND ND Elimination half-life, oral dose (h) 0.96 ± 0.26 20 1.59 ± 0.29 30 5.27 ± 2.01 17 Urinary recovery of stavudine (% of dose) Over 8 hours. 34 ± 16 19 ND ND Renal Impairment Data from two studies in adults indicated that the apparent oral clearance of stavudine decreased and the terminal elimination half-life increased as creatinine clearance decreased (see Table 10). C max and T max were not significantly altered by renal impairment. The mean ± SD hemodialysis clearance value of stavudine was 120 ± 18 mL/min (n = 12); the mean ± SD percentage of the stavudine dose recovered in the dialysate, timed to occur between 2 to 6 hours post-dose, was 31 ± 5%. Based on these observations, it is recommended that stavudine dosage be modified in patients with reduced creatinine clearance and in patients receiving maintenance hemodialysis [see ]. Table 10:

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