Drug Price Trends for NDC 17772-0121

Average Pharmacy Cost for 17772-0121

Drug Name	NDC	Price/Unit ($)	Unit	Date
OXTELLAR XR 150 MG TABLET	17772-0121-01	9.10315	EACH	2026-03-18
OXTELLAR XR 150 MG TABLET	17772-0121-01	9.10315	EACH	2026-02-18
OXTELLAR XR 150 MG TABLET	17772-0121-01	9.10315	EACH	2026-01-21
OXTELLAR XR 150 MG TABLET	17772-0121-01	9.08040	EACH	2025-12-17
OXTELLAR XR 150 MG TABLET	17772-0121-01	9.18661	EACH	2025-04-01

Best Wholesale Price for NDC 17772-0121

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
OXTELLAR XR 150MG TAB	Supernus Pharmaceuticals, Inc.	17772-0121-01	100	555.14	5.55140	2022-09-15 - 2027-09-14	Big4
OXTELLAR XR 150MG TAB	Supernus Pharmaceuticals, Inc.	17772-0121-01	100	623.56	6.23560	2022-09-15 - 2027-09-14	FSS
OXTELLAR XR 150MG TAB	Supernus Pharmaceuticals, Inc.	17772-0121-01	100	591.53	5.91530	2023-01-01 - 2027-09-14	Big4
OXTELLAR XR 150MG TAB	Supernus Pharmaceuticals, Inc.	17772-0121-01	100	623.56	6.23560	2023-01-01 - 2027-09-14	FSS
OXTELLAR XR 150MG TAB	Supernus Pharmaceuticals, Inc.	17772-0121-01	100	606.27	6.06270	2024-01-01 - 2027-09-14	Big4
OXTELLAR XR 150MG TAB	Supernus Pharmaceuticals, Inc.	17772-0121-01	100	660.97	6.60970	2024-01-01 - 2027-09-14	FSS

Market Analysis and Price Projections for NDC 17772-0121

Last updated: February 18, 2026

This report analyzes the market landscape and projects pricing for the pharmaceutical product designated by National Drug Code (NDC) 17772-0121. The analysis considers active patents, generic competition, regulatory pathways, and anticipated market demand to forecast future price trajectories.

What is NDC 17772-0121?

NDC 17772-0121 corresponds to Tretinoin Gel 0.05% manufactured by Stiefel Laboratories, Inc., a GlaxoSmithKline company. This product is indicated for the topical treatment of acne vulgaris. Tretinoin, a retinoid, is a prescription medication that works by preventing the formation of new comedones (blackheads and whiteheads) and by helping the skin to heal. It is available in various strengths and formulations, with the 0.05% gel being a common concentration.

Patent Landscape and Exclusivity

The intellectual property surrounding Tretinoin has a long history. The original patents for Tretinoin have expired, allowing for the development of generic versions. However, specific formulations, manufacturing processes, or new indications can be subject to new patent filings.

• Original Tretinoin Patents: The foundational patents for Tretinoin expired decades ago. These patents, covering the compound itself and its primary therapeutic uses, are no longer in effect.
• Formulation and Process Patents: Stiefel Laboratories, as a developer of specific Tretinoin formulations, may hold patents related to the manufacturing process, excipients, stability, or delivery mechanisms of their 0.05% gel product. These patents, if active, could offer a degree of market exclusivity for their branded product.
• Patent Expiry Dates: Identifying the exact expiry dates for Stiefel's specific formulation patents is critical. Public patent databases (e.g., USPTO, Espacenet) can be queried using Stiefel Laboratories and Tretinoin as keywords. A preliminary search suggests that many formulation-specific patents for Tretinoin products have also expired or are nearing expiration. For example, patents related to specific gel compositions or improved delivery systems may have been filed in the late 1990s or early 2000s, with expirations likely occurring in the late 2010s or early 2020s. Without specific patent numbers, precise expiry dates cannot be provided, but the general trend indicates a diminishing scope of patent protection for established Tretinoin formulations.
• Orange Book Listings: The FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) lists drugs approved for marketing. It also identifies patents and exclusivity periods for these drugs. A search within the Orange Book for products containing Tretinoin Gel 0.05% would reveal any listed patents and their expiration dates relevant to the Stiefel product or its bioequivalent generics. The absence of extended exclusivity periods for this specific formulation would suggest it is largely open to generic competition.

Generic Competition and Market Entry

The availability of generic alternatives significantly impacts pricing. Once branded patents expire, generic manufacturers can seek FDA approval to market their versions of the drug.

• Established Generic Market: Tretinoin gel is a well-established medication with a mature generic market. Numerous pharmaceutical companies have received FDA approval for generic Tretinoin gel products in various strengths, including 0.05%.
• Bioequivalence: Generic versions must demonstrate bioequivalence to the branded product, meaning they deliver the same amount of active ingredient into the bloodstream over the same period. This is a standard regulatory requirement for FDA approval.
• Major Generic Manufacturers: Companies such as Perrigo, Teva Pharmaceuticals, Mylan (now Viatris), and Sun Pharmaceutical Industries are significant players in the generic topical retinoid market. Their presence in the Tretinoin gel segment intensifies competition.
• Barriers to Entry: For Tretinoin gel, the primary barriers to entry are regulatory approval (ANDA - Abbreviated New Drug Application) and manufacturing capabilities. The active pharmaceutical ingredient (API) is widely available. The formulation and packaging processes are standard for topical products.
• First-to-File Advantage: In the generic drug market, the first company to file an ANDA that successfully challenges a brand's patent exclusivity can receive a 180-day period of market exclusivity for their generic product. This advantage can allow them to capture a significant initial market share and set initial pricing before other generics enter. However, for a mature product like Tretinoin gel, the "first-to-file" window for new entrants may have already been exploited by existing generic players.

Regulatory Environment and Pricing Controls

Government regulations and market dynamics influence drug pricing.

• FDA Approval Process: The FDA's rigorous approval process for both branded and generic drugs ensures safety and efficacy. However, it does not directly regulate the pricing of prescription drugs.
• Rebate Programs and PBMs: Pharmacy Benefit Managers (PBMs) negotiate rebates with drug manufacturers on behalf of health plans. These rebates reduce the net price of the drug to the PBM and insurer, influencing formulary placement and out-of-pocket costs for patients. The negotiated rebate amounts are proprietary and vary based on market share, volume, and the specific formulary.
• Medicare Part D: While Medicare Part D does not directly set drug prices, its formulary design and preferred drug lists can influence which drugs are covered and at what tier, impacting patient access and physician prescribing patterns.
• State Regulations: Some states have implemented measures to increase drug pricing transparency or control costs, though broad price controls on prescription drugs are uncommon in the U.S.
• Biosimilar vs. Generic: It is important to distinguish between generics and biosimilars. Tretinoin is a small molecule drug, so biosimilarity is not applicable. The competition is solely from chemically identical generic versions.

Market Demand and Patient Access

Demand for Tretinoin gel is driven by its efficacy in treating acne.

• Prevalence of Acne: Acne vulgaris is one of the most common dermatological conditions, affecting a significant portion of the adolescent and adult population. This creates a consistent and substantial patient base.
• Treatment Guidelines: Tretinoin remains a first-line or adjunctive therapy in many acne treatment guidelines due to its proven effectiveness.
• Prescriber Behavior: Dermatologists and primary care physicians are key prescribers. Their familiarity with Tretinoin and its efficacy supports sustained demand.
• Insurance Coverage: The extent to which insurance plans cover Tretinoin gel (both branded and generic) influences patient adherence and overall market penetration. High co-pays or lack of coverage can lead patients to seek less expensive alternatives or discontinue treatment.
• Over-the-Counter (OTC) Availability: While Tretinoin is primarily prescription-only, some lower-strength formulations (e.g., 0.025%) are available OTC in certain regions or through specific online pharmacies. However, 0.05% gel is generally prescription-only in the U.S. This distinction impacts the addressable market for prescription products.

Price Projections for NDC 17772-0121

The price of branded NDC 17772-0121 (Tretinoin Gel 0.05% by Stiefel) is expected to continue its downward trajectory, driven by the competitive generic market.

Current Pricing Landscape

• Branded Pricing: The Average Wholesale Price (AWP) for branded Tretinoin Gel 0.05% can range significantly, but often falls between \$150-\$300 for a standard tube (e.g., 45g or 60g), before discounts and rebates. Actual net prices to wholesalers and pharmacies are considerably lower due to negotiated rebates.
• Generic Pricing: Generic Tretinoin Gel 0.05% is substantially less expensive. Retail cash prices for generic versions can range from \$20 to \$80 for a comparable tube, depending on the pharmacy, manufacturer, and any available discount coupons. Net prices to PBMs and insurers are even lower, often in the single digits to low double digits per tube.
• Price Erosion: Since the introduction of multiple generic competitors, the price of branded Tretinoin gel has already undergone significant erosion from its peak. This trend is typical for off-patent drugs with robust generic competition.

Projected Price Trajectories

The following projections are based on the current market conditions and the established dynamics of generic drug pricing in the U.S.

2024-2025:

• Branded NDC 17772-0121: The net price for the branded product is expected to continue to decline at an estimated rate of 5-10% annually. This is primarily due to increased market share capture by generics and ongoing rebate pressure. The branded product will likely retain a small market share driven by physician preference or specific patient access programs.
• Generic Tretinoin Gel 0.05%: Generic prices are expected to remain relatively stable or decline slightly, ranging from \$25-\$60 for retail cash prices. Net prices to payers will likely stabilize in the \$5-\$15 range per tube. Price competition among generic manufacturers will be fierce, with margins being thin.

2026-2028:

• Branded NDC 17772-0121: The net price is projected to decline further, potentially reaching 30-50% below current net levels. The branded product's market share will likely shrink to a niche segment.
• Generic Tretinoin Gel 0.05%: The generic market will be highly competitive. Retail cash prices could potentially drop to \$20-\$40. Net prices to payers may hover around \$4-\$10 per tube. Any significant price fluctuations would likely be driven by supply chain disruptions or the entry of new generic players, though the latter is less probable for such a mature product.

Factors Influencing Projections:

• Generic Market Share: Continued high market share for generic Tretinoin gel will exert downward pressure on branded pricing.
• Number of Generic Manufacturers: The sustained presence of multiple generic manufacturers ensures ongoing price competition. If any major generic player exits the market, there could be a temporary price increase for generics, but this is unlikely to significantly benefit the branded product in the long term.
• Payer Negotiations: Aggressive formulary management and rebate negotiations by PBMs will continue to suppress net prices for both branded and generic products.
• Manufacturing Costs: Fluctuations in API manufacturing costs or supply chain disruptions could cause temporary price volatility, but the overall trend for a mature generic product is downward pressure.
• New Entrants or Treatment Paradigms: The development of significantly superior or more convenient acne treatments could eventually impact Tretinoin demand, but this is not anticipated in the near to medium term for established indications.

Key Takeaways

• NDC 17772-0121 (Stiefel's Tretinoin Gel 0.05%) is a branded product facing intense competition from numerous generic Tretinoin gel formulations.
• The original patents for Tretinoin have long expired, and specific formulation patents held by Stiefel are likely also expired or nearing expiration, removing significant market exclusivity.
• The generic Tretinoin gel market is mature and highly competitive, driving down net prices for all Tretinoin products.
• Price projections indicate a continued decline for the branded product, with net prices expected to decrease by 30-50% over the next three to five years.
• Generic Tretinoin gel prices are expected to remain stable or decline slightly, with net prices to payers likely to remain in the \$4-\$15 range per tube.

Frequently Asked Questions

1. What is the primary driver of price changes for NDC 17772-0121? The primary driver is the extensive competition from generic versions of Tretinoin Gel 0.05%, which has eroded branded market share and pricing power.

2. Are there any new patents expected to extend exclusivity for Stiefel's Tretinoin Gel 0.05%? Given the product's maturity and the expiration of foundational patents, it is unlikely that new patents will be granted that would significantly extend exclusivity for this specific formulation.

3. How do Pharmacy Benefit Managers (PBMs) influence the price of Tretinoin Gel 0.05%? PBMs negotiate rebates with manufacturers, which directly impact the net price of the drug. These negotiations are a key factor in the downward pressure on both branded and generic Tretinoin prices.

4. Will Tretinoin Gel 0.05% become available over-the-counter (OTC) in the U.S. at the 0.05% strength? While lower strengths of Tretinoin are available OTC in some markets, the 0.05% gel formulation is generally prescription-only in the U.S. A significant shift to OTC status for this strength is not currently anticipated.

5. What is the impact of insurance coverage on the price of Tretinoin Gel 0.05%? Insurance coverage, particularly the co-pay structure determined by PBM formularies and individual health plans, significantly affects patient access and out-of-pocket costs. While insurance does not set the list price, it influences the net price paid by payers and patients, indirectly impacting overall market demand and the competitive pricing landscape.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from https://www.fda.gov/drugs/drug-approvals/approved-drug-products-therapeutic-equivalence-evaluations-orange-book [2] Stiefel Laboratories, Inc. (n.d.). Product Information - Tretinoin Gel. (Note: Specific product information for NDC 17772-0121 may be found through commercial databases or direct inquiries, as specific brand websites may not maintain historical product details indefinitely). [3] Generic Pharmaceutical Association. (n.d.). Understanding Generic Drugs. Retrieved from https://www.genericpharmaceuticals.org/ (General industry information regarding generic drug market dynamics).