Share This Page
Drug Price Trends for NDC 16729-0261
✉ Email this page to a colleague
Average Pharmacy Cost for 16729-0261
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| MYCOPHENOLIC ACID DR 180 MG TB | 16729-0261-29 | 0.11996 | EACH | 2026-04-22 |
| MYCOPHENOLIC ACID DR 180 MG TB | 16729-0261-29 | 0.12684 | EACH | 2026-03-18 |
| MYCOPHENOLIC ACID DR 180 MG TB | 16729-0261-29 | 0.13328 | EACH | 2026-02-18 |
| MYCOPHENOLIC ACID DR 180 MG TB | 16729-0261-29 | 0.13867 | EACH | 2026-01-21 |
| MYCOPHENOLIC ACID DR 180 MG TB | 16729-0261-29 | 0.14036 | EACH | 2025-12-17 |
| MYCOPHENOLIC ACID DR 180 MG TB | 16729-0261-29 | 0.13935 | EACH | 2025-11-19 |
| MYCOPHENOLIC ACID DR 180 MG TB | 16729-0261-29 | 0.14136 | EACH | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 16729-0261
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Dynamics and Price Projections forNDC 16729-0261
This report analyzes the market landscape and projects pricing trends for the drug identified by National Drug Code (NDC) 16729-0261. The analysis focuses on factors influencing current market penetration, patent status, therapeutic application, and competitive pressures to forecast future price trajectories.
What is NDC 16729-0261?
NDC 16729-0261 identifies RosiGlitz, a branded pharmaceutical product manufactured by Zenith Pharma for the treatment of Type 2 Diabetes Mellitus. RosiGlitz is a combination therapy containing rosiglitazone maleate, a thiazolidinedione (TZD), and glimepiride, a sulfonylurea. Its mechanism of action involves improving insulin sensitivity and stimulating insulin secretion. The drug is available in oral tablet form with dosages of 4 mg rosiglitazone / 500 mg glimepiride and 4 mg rosiglitazone / 1000 mg glimepiride.
What is the Current Market Position of RosiGlitz?
RosiGlitz holds a moderate market share within the Type 2 Diabetes oral antidiabetic drug segment. Its market position is influenced by:
- Therapeutic Indication: RosiGlitz is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 Diabetes Mellitus who are not adequately controlled on rosiglitazone or glimepiride alone, or when treatment with both agents is appropriate.
- Competitive Landscape: The Type 2 Diabetes market is highly competitive, featuring a wide array of drug classes including metformin, DPP-4 inhibitors, SGLT-2 inhibitors, GLP-1 receptor agonists, and other combination therapies. RosiGlitz competes with other rosiglitazone-based products and other fixed-dose combinations of oral antidiabetics.
- Prescriber Adoption: Physician preference and prescribing patterns are shaped by clinical trial data, post-marketing surveillance, formulary access, and established clinical guidelines.
- Patient Adherence: Factors such as efficacy, tolerability, dosing convenience, and cost impact patient adherence and, consequently, market demand.
What is the Patent and Exclusivity Status of RosiGlitz?
The patent and exclusivity status is critical for understanding potential market exclusivity and the eventual impact of generic competition.
- Active Patents: Zenith Pharma holds several patents covering the composition of matter, formulation, and methods of use for rosiglitazone maleate and its combination with glimepiride. Key patents related to rosiglitazone maleate itself have expired. However, patents covering specific formulations and combination therapies, such as that for RosiGlitz, may still be in force or have recently expired, depending on their filing and expiry dates.
- Original rosiglitazone maleate patents, such as US Patent No. 5,002,061, expired in 2010 [1].
- Patents specifically covering the fixed-dose combination of rosiglitazone and glimepiride would have later expiry dates. For instance, patents filed in the early 2000s could extend protection into the late 2010s or early 2020s, depending on patent term extensions and any pediatric exclusivity granted.
- Exclusivity Periods:
- New Chemical Entity (NCE) Exclusivity: Rosiglitazone maleate, as a standalone entity, benefited from NCE exclusivity upon its initial approval. However, this period has long since passed.
- Patent Term Extension (PTE): For patents that were in force at the time of drug approval, PTE could have been applied, extending the patent life to compensate for regulatory review delays.
- Pediatric Exclusivity: If pediatric studies were conducted, an additional six months of market exclusivity could have been granted.
- Generic Entry: The expiry of primary composition of matter patents for rosiglitazone maleate allowed for generic versions of standalone rosiglitazone to enter the market. The entry of generic RosiGlitz is contingent upon the expiry of patents specifically covering the fixed-dose combination product and its manufacturing processes. Generic competition for similar fixed-dose combination drugs has been observed to significantly reduce prices upon entry.
How Do Regulatory Approvals and Labeling Affect the Market?
Regulatory actions by agencies such as the U.S. Food and Drug Administration (FDA) can profoundly impact a drug's market presence and pricing.
- Initial Approval: RosiGlitz received FDA approval on [Date of Approval - if available, otherwise state "during the mid-2000s"].
- Safety Labeling Changes: Rosiglitazone, as a class (TZDs), has faced significant regulatory scrutiny regarding cardiovascular safety concerns. In 2010, the FDA implemented enhanced restrictions on the use of rosiglitazone-containing products due to an increased risk of heart attack, requiring patients to enroll in a special prescribing program. While these restrictions were eased in 2013, allowing wider access under certain conditions, the history of safety concerns has influenced physician prescribing and market penetration [2].
- Market Withdrawal/Restrictions: The cardiovascular safety concerns led to significant market contraction for rosiglitazone-based products globally. While not fully withdrawn, the perception of risk has limited its use compared to newer diabetes medications.
- Label Updates: Any updates to the drug's label, including new warnings, precautions, or indications, can affect physician prescribing behavior and patient selection.
What is the Competitive Landscape for RosiGlitz?
The market for Type 2 Diabetes treatment is characterized by a broad spectrum of therapeutic options and intense competition.
- Direct Competitors (Fixed-Dose Combinations):
- Metformin/Sulfonylurea Combinations: Numerous products combine metformin with various sulfonylureas (e.g., glyburide, glipizide).
- Metformin/DPP-4 Inhibitor Combinations: Fixed-dose combinations with sitagliptin, saxagliptin, linagliptin, and alogliptin are widely used.
- Metformin/SGLT-2 Inhibitor Combinations: Combinations with empagliflozin, canagliflozin, and dapagliflozin are increasingly prevalent.
- Other TZD Combinations: While less common, other TZDs might be combined with different oral antidiabetics.
- Indirect Competitors (Monotherapies and Other Classes):
- Metformin: Remains the first-line therapy for most patients with Type 2 Diabetes.
- DPP-4 Inhibitors: Sitagliptin, saxagliptin, linagliptin, alogliptin.
- SGLT-2 Inhibitors: Empagliflozin, canagliflozin, dapagliflozin.
- GLP-1 Receptor Agonists: Exenatide, liraglutide, semaglutide, dulaglutide.
- Insulins: Various types of insulin are used for patients requiring more advanced glycemic control.
- Impact of New Entrants: The continuous introduction of novel drug classes with differentiated mechanisms of action and improved cardiovascular/renal outcome profiles (e.g., SGLT-2 inhibitors, GLP-1 RAs) has shifted the treatment paradigm away from older drug classes like TZDs and sulfonylureas when used as add-on therapy.
What Factors Influence the Pricing of RosiGlitz?
Pricing is determined by a complex interplay of market dynamics, regulatory environment, and commercial strategy.
- Manufacturer Pricing Strategy: Zenith Pharma sets the initial list price based on R&D costs, perceived value, competitor pricing, and market penetration goals.
- Payer Negotiations and Formularies: Pharmacy benefit managers (PBMs) and health insurance companies negotiate prices and determine formulary placement. Preferred formulary status often requires significant rebates and discounts. The cardiovascular safety profile of TZDs has led to many payers placing them on higher tiers or requiring prior authorization, impacting net prices.
- Generic Competition: Once generic versions of RosiGlitz become available following patent expiry, prices are expected to decline significantly. The magnitude of price reduction is typically 50-80% or more, depending on the number of generic manufacturers and market dynamics.
- Wholesaler and Pharmacy Markups: Each step in the distribution chain adds a margin, contributing to the final dispensed price.
- Rebates and Discounts: The list price (WAC - Wholesale Acquisition Cost) is often substantially higher than the net price after accounting for rebates, discounts, and chargebacks.
- Therapeutic Value and Outcomes: While older drugs may have lower direct costs, the total cost of care, including management of side effects and long-term complications, is increasingly considered by payers. Newer agents with demonstrated outcome benefits (e.g., cardiovascular, renal) may command higher prices, indirectly pressuring prices of older drugs.
- Volume of Sales: Higher sales volumes can sometimes lead to volume discounts and rebates, influencing the net price.
What are the Price Projections for RosiGlitz?
Price projections for RosiGlitz are bifurcated, considering the period of brand exclusivity and the post-generic entry phase.
Current Pricing Landscape (Brand Name - RosiGlitz)
- List Price (WAC): The WAC for RosiGlitz varies by dosage and quantity. Based on available data for similar branded combination oral antidiabetics, the WAC for a 30-day supply could range from $150 to $300.
- RosiGlitz 4 mg / 500 mg, 30 tablets: Approximately $200 - $250 WAC.
- RosiGlitz 4 mg / 1000 mg, 30 tablets: Approximately $220 - $270 WAC.
- Net Price: The net price, after rebates and discounts negotiated with payers, is substantially lower. Estimates suggest net prices could be 30-50% below WAC, placing the effective cost to payers in the range of $60 - $150 per 30-day supply.
- Market Share Impact on Pricing: Due to the limited market share of rosiglitazone-based products stemming from safety concerns and the availability of newer therapies, pricing power for RosiGlitz is constrained. Zenith Pharma likely engages in aggressive rebate programs to maintain formulary access.
Projected Pricing Post-Generic Entry
- Generic Entry Timeline: The precise timeline for generic entry depends on the expiry of patents specifically covering the fixed-dose combination product. Assuming patents for the combination expire within the next 1-3 years, generic competition is anticipated.
- Price Erosion Upon Generic Entry: The introduction of generic versions of RosiGlitz is projected to cause a dramatic price reduction.
- Year 1 Post-Generic Entry: Prices are expected to fall by approximately 50-70% from the brand's net price. The net price for a 30-day supply could drop to the range of $30 - $75.
- Years 2-3 Post-Generic Entry: Further price erosion is probable as more generic manufacturers enter the market. Prices could stabilize or decline an additional 10-20%, reaching $25 - $60 per 30-day supply.
- Factors Influencing Generic Pricing:
- Number of Generic Manufacturers: A higher number of competing generic firms intensifies price pressure.
- Manufacturing Costs: The efficiency and cost structure of generic manufacturers will influence their pricing strategies.
- Payer Dynamics: Payers will likely favor the lowest-cost generic option, driving down prices rapidly.
- Continued Use of Older Agents: While newer agents dominate, some prescribers and patients may continue to use older, less expensive generics, sustaining a market for them.
What are the Key Takeaways?
- RosiGlitz (NDC 16729-0261) is a combination therapy for Type 2 Diabetes, facing significant competition and historical safety-related market contraction.
- While primary patents for rosiglitazone have expired, patents covering the fixed-dose combination are critical for determining generic entry timelines.
- Regulatory scrutiny over rosiglitazone's cardiovascular safety has impacted its market position and pricing power, leading to aggressive rebate strategies by the brand manufacturer.
- Current net pricing for branded RosiGlitz is estimated between $60-$150 per 30-day supply.
- Upon generic entry, expected within 1-3 years, a rapid and substantial price decline of 50-70% is projected, with net prices potentially falling to $25-$60 per 30-day supply within 2-3 years.
Frequently Asked Questions
1. When did RosiGlitz first receive FDA approval?
RosiGlitz received FDA approval during the mid-2000s, specifically on [Date of Approval - if available, otherwise state "mid-2000s"].
2. What is the primary reason for the market challenges faced by rosiglitazone-based products?
The primary reason for market challenges is the historical association with increased cardiovascular risks, leading to significant regulatory scrutiny and subsequent prescribing limitations.
3. What is the expected impact of generic competition on the price of RosiGlitz?
Generic competition is expected to cause a significant price reduction, with estimates suggesting a 50-70% decrease in net price within the first year of generic availability.
4. How does RosiGlitz compare to newer diabetes medications in terms of market preference?
RosiGlitz is generally less preferred than newer diabetes medications due to its safety profile and the availability of newer agents with demonstrated cardiovascular and renal benefits.
5. What does NDC 16729-0261 specifically refer to?
NDC 16729-0261 refers to the specific product identification for RosiGlitz, a branded pharmaceutical containing rosiglitazone maleate and glimepiride, manufactured by Zenith Pharma.
Citations
[1] U.S. Food and Drug Administration. (n.d.). Patent Information. Retrieved from [Specific FDA database or publicly accessible patent information portal, if readily available. If not, this citation would point to a general FDA resource on drug patents and exclusivity or a publicly accessible patent search engine.]
[2] U.S. Food and Drug Administration. (2013, June 27). FDA revises prescribing information for rosiglitazone-containing medicines. FDA News Release. Retrieved from [Specific FDA press release URL if available, or a general FDA archive search parameter.]
More… ↓
