List of Excipients in Branded Drug DESVENLAFAXINE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Alembic Pharmaceuticals Limited	DESVENLAFAXINE	desvenlafaxine	46708-152	ALGINIC ACID
Alembic Pharmaceuticals Limited	DESVENLAFAXINE	desvenlafaxine	46708-152	CELLULOSE, MICROCRYSTALLINE
Alembic Pharmaceuticals Limited	DESVENLAFAXINE	desvenlafaxine	46708-152	CITRIC ACID MONOHYDRATE
Alembic Pharmaceuticals Limited	DESVENLAFAXINE	desvenlafaxine	46708-152	FERRIC OXIDE RED
Alembic Pharmaceuticals Limited	DESVENLAFAXINE	desvenlafaxine	46708-152	HYPROMELLOSE
Alembic Pharmaceuticals Limited	DESVENLAFAXINE	desvenlafaxine	46708-152	MAGNESIUM STEARATE
Alembic Pharmaceuticals Limited	DESVENLAFAXINE	desvenlafaxine	46708-152	POLYETHYLENE GLYCOL 6000

Generic Drugs Containing DESVENLAFAXINE

Company	Ingredient	NDC	Excipient
Hikma Pharmaceuticals USA Inc	desvenlafaxine	0054-0603	CELLULOSE, MICROCRYSTALLINE
Hikma Pharmaceuticals USA Inc	desvenlafaxine	0054-0603	FD&C BLUE NO. 1
Hikma Pharmaceuticals USA Inc	desvenlafaxine	0054-0603	FD&C RED NO. 40
Hikma Pharmaceuticals USA Inc	desvenlafaxine	0054-0603	FD&C YELLOW NO. 6
Hikma Pharmaceuticals USA Inc	desvenlafaxine	0054-0603	HYPROMELLOSE 2208
Hikma Pharmaceuticals USA Inc	desvenlafaxine	0054-0603	MAGNESIUM STEARATE
Hikma Pharmaceuticals USA Inc	desvenlafaxine	0054-0603	POLYETHYLENE GLYCOL 1000

What are the Most Frequently-Used Excipients in DESVENLAFAXINE?

# Of NDCs	Excipient
2	AMMONIA
44	CELLULOSE, MICROCRYSTALLINE
1	CI 77891
2	D&C RED NO. 27 ALUMINUM LAKE
2	ETHYLCELLULOSE
2	FD&C BLUE NO. 1
2	FD&C BLUE NO. 2

Excipient Strategy and Commercial Opportunities for Desvenlafaxine

Last updated: February 25, 2026

What is the current excipient profile for Desvenlafaxine?

Desvenlafaxine, a selective serotonin-norepinephrine reuptake inhibitor (SNRI) used to treat major depressive disorder, is formulated as an oral tablet. The excipient composition influences bioavailability, stability, and patient tolerability.

Common excipients in Desvenlafaxine formulations include:

• Fillers: Microcrystalline cellulose, lactose monohydrate
• Binders: Crospovidone, povidone
• Disintegrants: Croscarmellose sodium
• Lubricants: Magnesium stearate
• Coatings: Hypromellose, titanium dioxide

How does excipient selection impact the drug’s bioavailability and stability?

Excipient choices affect how Desvenlafaxine dissolves and is absorbed:

• Disintegrants like croscarmellose enhance tablet breakup, increasing dissolution rate.
• Fillers influence tablet size and flow properties.
• Coatings protect the active ingredient from environmental degradation (moisture, light), extending shelf life.

Variations in excipient sources or grades can impact consistent drug release and stability, affecting regulatory approval and patentability.

What are the regulatory considerations for excipient use?

Regulatory agencies, including the FDA and EMA, require detailed excipient documentation:

• GRAS status: Excipients must generally be recognized as safe.
• Declaration in labeling: All excipients are listed per regulatory standards.
• Impurity profile: Certain excipients may introduce impurities; testing is mandatory.

Post-approval, any formulation change, including excipient modifications, requires regulatory notification or supplemental approval.

What commercial strategies leverage excipient choices?

1. Developing proprietary excipients or unique grades can create formulation differentiation, offering patent extensions or new product labels.

2. Enhanced bioavailability formulations: Using excipients that improve absorption may allow for lower dosing, reducing manufacturing costs and potential side effects.

3. Extended-release formulations: Employing specific polymers, such as hydroxypropyl methylcellulose, enables sustained drug release, opening avenues for once-daily dosing and broader market access.

4. Stability improvements: Optimizing excipients for longer shelf life enables distribution to regions with challenging logistics, expanding market reach.

5. Patient compliance: Flavored coatings or taste-masking agents improve palatability, increasing adherence, especially in pediatric or geriatric populations.

How can excipient innovation translate into market advantages?

• Intellectual property: Patents on novel excipient combinations can block competitors.
• Regulatory exclusivity: Demonstrating improved stability or bioavailability through excipient changes can justify new filings for better market positioning.
• Cost efficiencies: Bulk sourcing or alternative excipients reduce manufacturing costs, improving margins.

What are potential challenges in excipient strategy for Desvenlafaxine?

• Regulatory hurdles: Novel excipients or significant formulation changes require extensive testing.
• Supply chain stability: Dependency on certain excipients may lead to bottlenecks or price volatility.
• Formulation complexity: Achieving balance between drug release, stability, and patient acceptability demands thorough R&D.

Summary table: Excipient Types and Their Roles in Desvenlafaxine Formulations

Excipient Type	Function	Influence	Commercial Opportunity
Fillers	Volume increase	Affects tablet size	Cost-effective sourcing
Binders	Tablet cohesion	Impacts dissolution	Patent protection via novel binders
Disintegrants	Tablet breakup	Enhances absorption	Improved bioavailability
Lubricants	Manufacturing ease	Affects dissolution	Cost reduction strategies
Coatings	Protection & taste	Stability & compliance	Differentiation through coatings

Key Takeaways

• Excipient selection in Desvenlafaxine formulations is crucial for bioavailability, stability, and patient compliance.
• Innovation in excipient use offers avenues for patent extension, formulation differentiation, and cost savings.
• Regulatory compliance shapes excipient strategy, requiring rigorous safety and stability data.
• Commercial opportunities include developing controlled-release forms and optimizing excipients for regional distribution.
• Supply chain management and formulation complexity pose ongoing challenges.

FAQs

1. Can excipient modifications extend Desvenlafaxine’s patent life?
Yes, strategic changes to excipients that result in novel formulations can be patented, providing exclusivity beyond the original patent.

2. Are there excipients specific to enhancing bioavailability in Desvenlafaxine?
Disintegrants and solubilizers are key, with choices like croscarmellose sodium or polar polymers improving dissolution.

3. How do excipient choices affect regulatory approval?
Excipients must meet safety standards and be well-documented; significant modifications may require additional filings.

4. What trends are emerging in excipient technology for antidepressants?
Use of biodegradable coatings, taste-masking agents, and multi-functional polymers.

5. How important is supply chain stability for excipients in Desvenlafaxine production?
Critical. Disruptions can delay manufacturing and increase costs, affecting market supply and revenue.

---

References:

[1] U.S. Food and Drug Administration. (2022). Guidance for Industry: Excipients in Drug Products.
[2] European Medicines Agency. (2021). Reflection Paper on the Use of Excipients in Drug Formulations.
[3] Smith, J., & Lee, T. (2020). Excipient strategies in pharmaceutical development. International Journal of Pharmaceutics, 587, 119637.