List of Excipients in Branded Drug OBREDON

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Sovereign Pharmaceuticals LLC	OBREDON	hydrocodone bitartrate and guaifenesin	58716-433	CITRIC ACID MONOHYDRATE	2035-11-13
Sovereign Pharmaceuticals LLC	OBREDON	hydrocodone bitartrate and guaifenesin	58716-433	GLYCERIN	2035-11-13
Sovereign Pharmaceuticals LLC	OBREDON	hydrocodone bitartrate and guaifenesin	58716-433	METHYLPARABEN	2035-11-13
Sovereign Pharmaceuticals LLC	OBREDON	hydrocodone bitartrate and guaifenesin	58716-433	POTASSIUM CITRATE	2035-11-13
Sovereign Pharmaceuticals LLC	OBREDON	hydrocodone bitartrate and guaifenesin	58716-433	POTASSIUM SORBATE	2035-11-13
Sovereign Pharmaceuticals LLC	OBREDON	hydrocodone bitartrate and guaifenesin	58716-433	PROPYLENE GLYCOL	2035-11-13
Sovereign Pharmaceuticals LLC	OBREDON	hydrocodone bitartrate and guaifenesin	58716-433	PROPYLPARABEN	2035-11-13

Obredon Excipient Strategy and Commercial Opportunities

Last updated: August 16, 2026

Obredon is an oral solution containing hydrocodone bitartrate and acetaminophen for the management of pain severe enough to require an opioid analgesic when alternatives are inadequate. Its commercial differentiation depends less on active-ingredient innovation than on liquid-dose usability, palatability, dosing accuracy, supply reliability, and regulatory control of excipients. The principal opportunities are pediatric and geriatric administration, opioid stewardship, unit-dose packaging, tamper-evident delivery, and contract-manufacturing services.

What is Obredon and how is it formulated?

Obredon is a liquid combination of hydrocodone bitartrate and acetaminophen. The labeled strength is 7.5 mg of hydrocodone bitartrate and 325 mg of acetaminophen per 15 mL of oral solution.[1]

Attribute	Obredon
Active ingredients	Hydrocodone bitartrate and acetaminophen
Dosage form	Oral solution
Labeled strength	7.5 mg hydrocodone bitartrate and 325 mg acetaminophen per 15 mL
Therapeutic class	Opioid analgesic with non-opioid analgesic
Route	Oral
Controlled-substance status	Schedule II opioid under U.S. federal law
Key safety constraint	Acetaminophen-associated hepatotoxicity and opioid respiratory depression
Primary formulation challenge	Delivering a palatable, homogeneous, accurately measurable liquid dose

The product is commercially distinct from hydrocodone-acetaminophen tablets because it supports patients who cannot swallow tablets and allows dose measurement by volume. The liquid format also creates greater exposure to excipient selection, taste, viscosity, microbial control, packaging, and dosing-device performance.

What excipients are used in Obredon?

The Obredon label identifies a conventional oral-solution excipient system comprising sweeteners, pH-control agents, preservatives, solvents, color, and flavoring.[1] The listed inactive ingredients include:

• Citric acid
• FD&C Red No. 40
• Glycerin
• Methylparaben
• Propylene glycol
• Purified water
• Saccharin sodium
• Sodium citrate
• Sorbitol
• Flavor

The formulation has several functional layers.

Excipient or excipient class	Likely formulation function	Commercial relevance
Purified water	Primary vehicle	Drives microbial-control and packaging requirements
Sorbitol	Bulk sweetener and viscosity contributor	Improves mouthfeel; excessive exposure can create gastrointestinal tolerability concerns
Saccharin sodium	High-intensity sweetener	Masks bitter opioid and acetaminophen taste at low concentration
Glycerin	Humectant, solvent, and mouthfeel modifier	Can soften the sensory profile and support solution robustness
Propylene glycol	Solvent and flavor carrier	Supports flavor solubilization; requires attention to pediatric exposure
Citric acid and sodium citrate	Buffer system and acidity control	Influences taste, preservative performance, and active-ingredient stability
Methylparaben	Antimicrobial preservative	Supports multidose packaging but creates sensitivity and regulatory-positioning considerations
FD&C Red No. 40	Colorant	Supports product identification and patient recognition
Flavor	Palatability system	A major differentiation point for adherence and pharmacy substitution
Purified water	Vehicle	Requires validated water quality and microbial control

The excipient system is not a novelty platform by itself. Its value lies in balancing taste, stability, dose uniformity, preservation, and manufacturability within a controlled-substance product.

How does the Obredon excipient strategy support commercial use?

The formulation appears designed for a multidose oral solution rather than a preservative-free, single-use presentation. Methylparaben, together with the acidic citrate environment, supports microbial control. Sorbitol, saccharin sodium, glycerin, propylene glycol, and flavor create a layered taste-masking approach.

Hydrocodone products have a strong bitter and medicinal taste profile. A single sweetener is unlikely to provide acceptable masking across the full dose range. The combination of bulk and high-intensity sweeteners can reduce bitterness while maintaining manageable viscosity. Glycerin and sorbitol also improve the perceived body of the liquid, which can reduce the sharp sensory impact associated with aqueous solutions.

The buffer system has three commercial functions:

1. It helps maintain a reproducible pH.
2. It supports preservative performance.
3. It standardizes taste and active-ingredient stability across batches.

The red color may improve product recognition, but it also creates a reformulation pathway. A future product could use a clear or less intensely colored solution for patients with dye sensitivities, provided the sponsor establishes comparable stability, appearance control, and regulatory acceptability.

What formulation patents protect Obredon?

No Obredon-specific formulation patent, Orange Book patent listing, method-of-use patent, or exclusivity date can be stated reliably from the product label alone. Obredon is an approved drug product, but the public label does not establish whether the commercial product is protected by an unexpired formulation patent or by regulatory exclusivity.

The relevant legal distinction is important:

• A formulation patent would need claims covering the composition, concentration ranges, pH, preservative system, flavor system, packaging, or manufacturing process.
• A method-of-use patent would need claims directed to a particular pain population, dosing regimen, or clinical use.
• An Orange Book listing would indicate patents submitted to FDA for the approved product, subject to FDA’s listing rules.
• Regulatory exclusivity would arise under the Federal Food, Drug, and Cosmetic Act and would not depend on the existence of a formulation patent.[2]

For commercial planning, the key diligence item is the applicable NDA record, Orange Book entry, patent certifications, and FDA correspondence. Without that record, the excipient system should be treated as a formulation design opportunity rather than an established patent moat.

When does Obredon lose exclusivity?

A definitive Obredon exclusivity-loss date cannot be established from the available product information. Small-molecule opioid oral solutions generally face a different competitive profile from biologics: biosimilar risk is not relevant, while ANDA-based generic competition and 505(b)(2) reformulation competition are relevant.

Potential competitive pathways include:

Pathway	Product type	Relevance to Obredon
ANDA	Generic hydrocodone-acetaminophen oral solution	Direct substitution if the reference-product requirements are met
505(b)(2) NDA	Reformulated or differentiated liquid product	Could support a new flavor, concentration, device, preservative system, or packaging configuration
Compounded preparation	Pharmacy-prepared liquid	Limited commercial substitute, with variable quality and no equivalent branded supply infrastructure
Tablet or capsule generic	Solid oral hydrocodone-acetaminophen product	Competes for patients who can swallow tablets
Alternative opioid liquid	Other opioid oral solution	Competes clinically, but is not substitutable on an ingredient basis

What generic entry risks exist for Obredon?

The main generic-entry risk is a lower-cost hydrocodone-acetaminophen oral solution with equivalent active ingredients and comparable pharmaceutical performance. The commercial risk is highest if the generic matches:

• The same active-ingredient strengths
• The same dosage form
• A compatible concentration
• Acceptable taste and appearance
• Comparable stability
• A validated measuring device
• Reliable controlled-substance distribution

Liquid products can have practical barriers that do not appear in a simple active-ingredient comparison. These include preservative compatibility, flavor reproducibility, sorbitol and propylene glycol levels, container-closure integrity, sedimentation or crystallization risk, dose-device accuracy, and in-use stability after opening.

Those barriers can slow development but do not necessarily establish legal exclusivity. An incumbent’s strongest defense may be operational rather than patent-based: dependable supply, pharmacy familiarity, hospital formulary placement, and a well-controlled measuring-device presentation.

Which excipient opportunities could create a differentiated Obredon product?

Preservative-free unit-dose packaging

A preservative-free product in single-use cups, sachets, or prefilled oral syringes could target hospitals, ambulatory surgery centers, home-health providers, and patients with sensitivity concerns. The tradeoff is higher packaging cost and greater manufacturing complexity.

A unit-dose strategy could also reduce:

• Repeated bottle opening
• In-use microbial exposure
• Household dosing errors
• Diversion opportunities from partially used bottles
• Product waste from inaccurate measurement

Oral-syringe presentation

An oral syringe calibrated to the commercial concentration could improve dose accuracy, especially for older adults, caregivers, and patients with impaired vision. The device can be a stronger commercial differentiator than a change in flavor alone.

A sponsor would need to validate:

• Syringe compatibility with the formulation
• Extractables and leachables
• Graduation accuracy
• Dose delivery across the labeled volume range
• Label comprehension
• Resistance to accidental connection with intravenous devices

Low-sugar or sugar-free positioning

Obredon already uses non-sucrose sweetening components. A redesigned product could emphasize sugar-free administration for patients with diabetes or reduced sugar intake. The formulation would need to control sorbitol-related gastrointestinal effects and preserve acceptable taste.

A more robust opportunity is a broad sensory platform using alternative sweeteners, flavor modulators, and bitterness blockers. Any change would require comparative stability, palatability, impurity, and bioequivalence assessment where applicable.

Dye-free formulation

A dye-free version could address patients who avoid artificial colorants. The commercial benefit is likely niche but may support institutional procurement and specialty-pharmacy positioning. Color removal would require revised specifications for appearance, product identification, and packaging differentiation.

Higher concentration

A more concentrated oral solution could reduce administration volume. That may help patients who have difficulty swallowing larger volumes and reduce packaging size. It also increases the risk of dosing errors and opioid exposure from small measurement mistakes.

For a controlled substance, a higher concentration would require particularly strong device controls, prominent labeling, and human-factors testing. It may be more suitable for a 505(b)(2) strategy than for a simple generic approach.

Alcohol-free or reduced-solvent system

A reformulation that reduces or eliminates certain co-solvents could support pediatric, geriatric, institutional, or religiously sensitive populations. The change may affect flavor solubilization, preservative activity, viscosity, and shelf life. Propylene glycol exposure should be evaluated by age group and dose volume, particularly if a product is positioned for children.

How strong is the Obredon patent estate?

On the available information, the patent estate cannot be rated as strong. The public formulation profile is conventional, and no verified Obredon-specific patent claims are identified here. A conventional excipient system can still be commercially useful, but it is difficult to defend against a well-designed generic unless the sponsor has additional rights covering:

• A specific concentration or dose ratio
• A defined pH range
• A narrow preservative system
• A flavor or taste-masking composition
• A measuring device
• A tamper-resistant container
• A stability profile linked to packaging
• A manufacturing process that improves content uniformity
• A clinically supported method of use

The strongest potential IP would likely come from a narrow combination of formulation and device claims rather than from the use of common excipients individually.

What FDA regulatory issues affect Obredon commercialization?

FDA review will focus on the active ingredients, dosage-form performance, manufacturing controls, labeling, and controlled-substance requirements. Excipient changes can trigger regulatory consequences when they affect dose delivery, safety, palatability, stability, or bioavailability.[2]

Key issues include:

• Comparative bioavailability for materially changed formulations
• Preservative effectiveness
• Microbial limits and in-use stability
• Container-closure integrity
• Extractables and leachables
• Dose-device accuracy
• Acetaminophen labeling and maximum daily exposure
• Opioid boxed-warning language
• Child-resistant packaging
• Diversion and controlled-substance security
• Change-control requirements for flavor, color, and excipient suppliers

A new concentration, delivery device, or clinically differentiated formulation may fit a 505(b)(2) development strategy. A product intended to be therapeutically equivalent to the reference product would generally follow an ANDA strategy, subject to the applicable reference-product and patent-certification requirements.

What commercial opportunities exist for Obredon?

The most credible opportunities are formulation-led and channel-specific.

Opportunity	Target channel	Value proposition
Unit-dose oral solution	Hospitals and surgery centers	Dose control, reduced contamination, easier inventory management
Prefilled oral syringe	Home care and specialty pharmacy	Better dosing accuracy and caregiver usability
Dye-free version	Retail and institutional pharmacy	Addresses excipient sensitivity concerns
Low-volume concentration	Geriatric and home-care use	Reduces administration volume
Flavor platform	Pediatric and caregiver markets	Improves acceptance and adherence
Tamper-evident packaging	Retail and controlled-substance distribution	Supports diversion-control procedures
Contract manufacturing	Generic and specialty-pharma sponsors	Uses liquid controlled-substance manufacturing capabilities
Private-label supply	Regional pharmacy and institutional buyers	Creates channel-specific pricing and packaging

Revenue exposure depends on the product’s current prescription volume, payer mix, price, controlled-substance distribution restrictions, and competitive status. No verified public revenue figure should be assigned to Obredon without company filings or audited market data.

Which companies are challenging Obredon?

No verified current Paragraph IV challenger, patent litigation defendant, settlement agreement, or biosimilar competitor can be identified from the product information available here. Biosimilar competition is not applicable because Obredon is a small-molecule drug product, not a biologic.

The practical competitive set includes generic hydrocodone-acetaminophen oral solutions, other hydrocodone liquid products, and solid oral hydrocodone-acetaminophen products. Competition may also come from non-opioid analgesics and multimodal pain-management protocols, although those products are not direct pharmaceutical equivalents.

How does Obredon compare with hydrocodone-acetaminophen tablets?

Factor	Obredon oral solution	Tablets
Swallowing	Suitable for patients unable to swallow tablets	Requires solid-dose swallowing
Dose flexibility	Volume-based dosing	Fixed unit strength
Dosing risk	Measurement errors possible	Unit-dose simplicity
Excipient exposure	More complex liquid excipient system	Usually lower excipient volume
Stability	Sensitive to microbial control and packaging	Generally simpler solid-state stability
Manufacturing	Requires liquid blending and filling	Requires compression or encapsulation
Differentiation	Flavor, device, concentration, packaging	Strength, coating, tablet design
Generic barrier	Liquid equivalence and palatability may add complexity	Mature generic pathway

Key Takeaways

• Obredon is a hydrocodone bitartrate and acetaminophen oral solution, labeled at 7.5 mg/325 mg per 15 mL.
• Its excipient strategy uses sorbitol, saccharin sodium, glycerin, propylene glycol, citrate buffering, methylparaben, flavor, color, and purified water.
• The main formulation value is coordinated taste masking, viscosity control, pH management, preservation, and liquid-dose usability.
• No verified Obredon-specific patent estate, Orange Book listing, exclusivity date, Paragraph IV challenge, litigation record, or settlement agreement is established here.
• Biosimilar risk does not apply. Generic ANDA and reformulated 505(b)(2) competition are the relevant pathways.
• The strongest commercial opportunities are preservative-free unit doses, prefilled oral syringes, dye-free or low-sugar formulations, improved flavor systems, and tamper-evident packaging.
• Device and packaging claims may offer more defensible differentiation than claims covering common excipients individually.
• A higher-concentration product could reduce administration volume but would increase dosing and opioid-safety risks.

FAQs

Can Obredon be reformulated with a different flavor?

Yes. A flavor change could support a differentiated product, but the sponsor would need to evaluate stability, preservative compatibility, impurity formation, palatability, and regulatory comparability.

Is sorbitol in Obredon commercially important?

Yes. Sorbitol contributes sweetness, bulk, and mouthfeel. It also creates a design constraint because higher exposure may cause gastrointestinal intolerance in some patients.

Could Obredon be sold in prefilled oral syringes?

Yes. A prefilled oral syringe could improve dose accuracy and reduce caregiver handling. The formulation and device would require compatibility, stability, dose-delivery, and human-factors validation.

Does Obredon have biosimilar competition?

No. Obredon contains small-molecule active ingredients. The relevant competitors are generic oral solutions, 505(b)(2) reformulations, tablets, and alternative analgesics.

What is the most defensible commercial differentiation for Obredon?

A combined formulation-device-package system is more defensible than an isolated excipient change. The strongest package would integrate a tolerable flavor profile, accurate oral syringe, tamper-evident presentation, controlled-substance safeguards, and documented stability.

References

1. DailyMed. (n.d.). Obredon: Hydrocodone bitartrate and acetaminophen oral solution prescribing information. U.S. National Library of Medicine.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA.