Last updated: March 1, 2026
What Is NDC 00527-2803?
NDC 00527-2803 corresponds to Aplenzin (bupropion hydrobromide) Extended-Release Tablets, 174 mg. Aplenzin is an antidepressant used primarily for the treatment of major depressive disorder and sometimes off-label for smoking cessation. It belongs to the class of aminoketones and acts as a norepinephrine-dopamine reuptake inhibitor.
Market Overview
Current Market Size
- The US antidepressant market was estimated at approximately $14.5 billion in 2022, with bupropion formulations accounting for roughly 25%.
- Aplenzin holds an estimated 1-2% share of the bupropion market, primarily due to its distinct formulation, patent status, and competitive positioning.
Key Competitors
Patent Status and Market Exclusivity
- Aplenzin's patent protections expired in 2024, opening the market for generics.
- Current patents or exclusivities may still restrict generic entry for a limited period, depending on legal challenges and patent litigation.
Regulatory Environment
- FDA approvals for new indications could expand market size.
- Pricing federally regulated under Medicaid and private insurers influences net revenue.
Price Analysis
Historical Pricing
- Brand-name Aplenzin: Historically sold at approximately $5.50 per tablet (174 mg).
- Generic bupropion XR: Prices range between $0.10 - $0.30 per tablet for equivalent doses, indicating a substantial price gap favoring generics.
Current Price Trends
| Product |
Approximate Price/Tablet |
Market Share (2022) |
Notes |
| Aplenzin |
$5.50 |
1-2% |
Premium price, limited by patent exclusivity |
| Generic bupropion XR |
$0.10 - $0.30 |
80-90% |
Price leader, aggressive marketing, formulary inclusion |
Future Price Projections
- Post-exclusivity: Generic bupropion XR is likely to reduce Aplenzin’s price to near generic levels, with possible stability around $0.20 per tablet.
- Brand continuation: If GSK retains patent rights or patents are extended via litigation, prices may stabilize around $3-$5 per tablet for branded Aplenzin for 1-2 years, with potential discounts for bulk and negotiated contracts.
Market Penetration Potential
- Generic competition: Will significantly pressure Aplenzin prices, especially in Medicaid and large managed care plans.
- Premium niche: Aplenzin may maintain a higher price in specific niches where clinicians prefer the hydrobromide salt for tolerability or patient-specific reasons.
Investment and R&D Outlook
- No current FDA pipeline applications suggest immediate new indications or formulations.
- Patent expiry in 2024 signals potential market share erosion but also presents opportunities for value-based pricing strategies for remaining branded versions.
Strategic Considerations
- Patent litigation and legal challenges are key determinants in price trajectory.
- Market penetration depends on formulary inclusion and physician prescribing habits.
- Pricing strategies must consider price elasticity, competitor behavior, and payer negotiations.
Key Takeaways
- The total US antidepressant market is over $14 billion.
- Aplenzin's premium pricing faced significant headwinds post-patent expiry in 2024.
- Expect generics to dominate, with prices falling below $0.30 per tablet.
- Branded Aplenzin might sustain prices around $3-$5 per tablet for 1-2 years post-patent expiry under strategic patent protections.
- Market share will hinge on formulary decisions, physician preference, and legal dynamics.
FAQs
1. When will generic versions of Aplenzin enter the market?
Generic bupropion XR products are expected to enter once patent protections expire or are invalidated, estimated in 2024.
2. How will pricing change after patent expiration?
Prices for Aplenzin are projected to decline toward generic levels, around $0.20 per tablet, unless brand protections are extended through legal means.
3. What are the main competitors to Aplenzin?
Generic bupropion XR products, Wellbutrin XL, and Zyban are the primary competitors.
4. Can Aplenzin maintain premium pricing?
Only if patent rights are extended or unique differentiations convince payers and physicians to prefer the branded version over generics.
5. What are potential growth areas for Aplenzin?
New indications, expanded formulary access, or unique patient tolerability profiles could support premium pricing or enhance market share.
References
[1] IQVIA. (2022). US Prescription Market Data.
[2] FDA. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
[3] Reports on Bupropion Market Trends 2022-2025. MarketWatch.
