PYRIDOXINE HYDROCHLORIDE Drug Patent Profile

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When do Pyridoxine Hydrochloride patents expire, and when can generic versions of Pyridoxine Hydrochloride launch?

Pyridoxine Hydrochloride is a drug marketed by Bel Mar, Dell Labs, Dr Reddys, Elkins Sinn, Epic Pharma Llc, Fresenius Kabi Usa, Luitpold, Mylan Institutional, and Watson Labs. and is included in ten NDAs.

The generic ingredient in PYRIDOXINE HYDROCHLORIDE is pyridoxine hydrochloride. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the pyridoxine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pyridoxine Hydrochloride

A generic version of PYRIDOXINE HYDROCHLORIDE was approved as pyridoxine hydrochloride by FRESENIUS KABI USA on December 31^st, 1969.

Summary for PYRIDOXINE HYDROCHLORIDE

US Patents:	0
Applicants:	9
NDAs:	10
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	89
DailyMed Link:	PYRIDOXINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PYRIDOXINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bahria University	NA
Innovative Medicines Initiative	PHASE2
TASK Applied Science	PHASE2

See all PYRIDOXINE HYDROCHLORIDE clinical trials

Pharmacology for PYRIDOXINE HYDROCHLORIDE

Ingredient-type	Analogs/Derivatives Vitamin B 6
Drug Class	Vitamin B6 Analog

Medical Subject Heading (MeSH) Categories for PYRIDOXINE HYDROCHLORIDE

Vitamin B Complex

US Patents and Regulatory Information for PYRIDOXINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bel Mar	PYRIDOXINE HYDROCHLORIDE	pyridoxine hydrochloride	INJECTABLE;INJECTION	080761-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Fresenius Kabi Usa	PYRIDOXINE HYDROCHLORIDE	pyridoxine hydrochloride	INJECTABLE;INJECTION	080618-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes
Dr Reddys	PYRIDOXINE HYDROCHLORIDE	pyridoxine hydrochloride	INJECTABLE;INJECTION	080572-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Luitpold	PYRIDOXINE HYDROCHLORIDE	pyridoxine hydrochloride	INJECTABLE;INJECTION	080669-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Dell Labs	PYRIDOXINE HYDROCHLORIDE	pyridoxine hydrochloride	INJECTABLE;INJECTION	083771-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Dell Labs	PYRIDOXINE HYDROCHLORIDE	pyridoxine hydrochloride	INJECTABLE;INJECTION	083772-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Epic Pharma Llc	PYRIDOXINE HYDROCHLORIDE	pyridoxine hydrochloride	INJECTABLE;INJECTION	087967-001	Oct 1, 1982		DISCN	No	No

Pyridoxine Hydrochloride Market Dynamics, Patent Status, FDA Regulation, and Financial Outlook

Last updated: October 28, 2026

Pyridoxine hydrochloride is the hydrochloride salt of vitamin B6 and is sold primarily as a generic prescription injection, an over-the-counter supplement ingredient, and a pharmaceutical-grade active pharmaceutical ingredient. The market is mature, fragmented, and price-sensitive. Commercial value is concentrated in supply reliability, injectable manufacturing, hospital contracts, dietary-supplement distribution, and compliance rather than in patent exclusivity.

No single audited market-size figure captures pyridoxine hydrochloride revenue because sales are divided among prescription products, OTC supplements, food fortification, animal nutrition, pharmaceutical ingredients, and combination products. The prescription injectable segment has limited revenue but higher operational barriers than tablets and supplements.

What is pyridoxine hydrochloride used for?

Pyridoxine hydrochloride is used to prevent or treat vitamin B6 deficiency and to manage certain clinical conditions associated with inadequate pyridoxine levels. FDA-approved labeling identifies uses that include pyridoxine deficiency caused by inadequate dietary intake, malabsorption, drug-induced deficiency, and certain metabolic conditions. Pyridoxine injection is also used when oral administration is not feasible or when rapid parenteral treatment is required (FDA, 2023a).

Common applications include:

• Treatment of vitamin B6 deficiency
• Prevention of isoniazid-associated neuropathy
• Nutritional support in hospitalized patients
• Parenteral nutrition formulations
• OTC multivitamin and B-complex products
• Prenatal vitamins
• Food and animal-feed fortification
• Pharmaceutical and nutraceutical manufacturing

Pyridoxine hydrochloride is water-soluble and is generally easier to formulate for aqueous injection than poorly soluble alternatives. Its low molecular complexity and long commercial history make it a commodity-like pharmaceutical ingredient.

What is the FDA regulatory status of pyridoxine hydrochloride?

Pyridoxine hydrochloride is an FDA-recognized active pharmaceutical ingredient with approved prescription and nonprescription uses. The principal prescription form is an injectable product, generally supplied in concentrations such as 100 mg/mL. Oral tablets and liquid products are sold across prescription, OTC, and supplement channels.

FDA product categories

Product type	Regulatory pathway	Principal market
Pyridoxine hydrochloride injection	Abbreviated or legacy prescription approval, depending on product	Hospitals, clinics, emergency care
Oral tablets	OTC monograph, approved drug, or supplement pathway depending on labeling	Retail and e-commerce
Multivitamin and B-complex products	OTC drug or dietary supplement pathway	Consumer health
Prenatal vitamins	OTC drug or dietary supplement pathway	Maternal health
Pharmaceutical-grade API	Drug-substance manufacturing under cGMP	Generic and branded drug manufacturers
Food and feed ingredient	Food, fortification, or feed-use requirements	Food and animal nutrition

Prescription products must comply with current good manufacturing practice, drug listing, labeling, quality controls, and applicable FDA requirements. Dietary supplements are regulated under a different framework and cannot make disease-treatment claims without triggering drug regulation.

The FDA labeling framework for pyridoxine injection is relatively established. The principal regulatory risks are manufacturing quality, sterility assurance, container closure, assay, impurities, particulate matter, and supply continuity rather than clinical development.

What is the Orange Book status of pyridoxine hydrochloride?

Pyridoxine hydrochloride has no commercially important active patent estate in the Orange Book. The molecule and its basic pharmaceutical uses have been known for decades, and any historical composition or use patents have expired.

The Orange Book remains relevant for identifying approved prescription products and any listed patents or exclusivity. For a generic pyridoxine hydrochloride product, the commercial review should focus on:

1. Whether the reference product has an active listing.
2. Whether any product-specific patent or regulatory exclusivity remains.
3. Whether the generic product has an approved ANDA.
4. Whether the dosage form has additional manufacturing or facility constraints.

There is no meaningful remaining period of new chemical entity exclusivity for pyridoxine hydrochloride. Any current prescription competition is therefore primarily generic.

What patents protect pyridoxine hydrochloride?

No enforceable composition-of-matter patent is expected to protect pyridoxine hydrochloride as a molecule. The principal technology is public domain.

Potentially relevant historical or peripheral patent categories include:

• Injectable formulations
• Stabilized aqueous solutions
• Combination vitamin products
• Controlled-release oral dosage forms
• Parenteral nutrition compositions
• Manufacturing or purification processes
• Packaging systems that improve stability

These categories generally do not create broad market exclusivity for standard pyridoxine hydrochloride tablets or injection. A patent covering a narrow formulation could affect a particular product, but it would not prevent competitors from selling conventional pyridoxine hydrochloride in a different formulation or package.

Patent strength assessment

Patent category	Current strategic strength	Commercial implication
Core molecule	None	No composition-of-matter barrier
Standard tablet	Low	Multiple substitute products
Standard injection	Low to moderate	Manufacturing and sterility barriers matter more than patents
Stabilized formulation	Potentially moderate if valid and unexpired	Product-specific protection only
Combination vitamin product	Low	Numerous design-around options
Manufacturing process	Low to moderate	Relevant to cost and quality, usually not market blocking
Delivery system	Variable	Relevant only to differentiated dosage forms

Patent strength is therefore weak at the product level and moderate only where a company controls a difficult injectable process, qualified facility, or specialized formulation.

When does pyridoxine hydrochloride lose exclusivity?

Pyridoxine hydrochloride has already lost conventional pharmaceutical exclusivity. There is no expected remaining period of:

• New chemical entity exclusivity
• Orphan-drug exclusivity for the standard ingredient
• Pediatric exclusivity tied to a current innovative product
• Broad formulation exclusivity covering ordinary tablets or injection

The relevant commercial question is not when exclusivity expires, but whether a supplier can maintain a cost, quality, regulatory, or distribution advantage after exclusivity has ended.

How many patents cover pyridoxine hydrochloride?

No small, commercially meaningful patent family is expected to cover the active ingredient itself. Patent databases contain historical applications involving vitamin B6, combinations, formulations, therapeutic uses, and manufacturing methods, but those records should not be treated as active market barriers without claim-level review and jurisdiction-specific status verification.

For diligence purposes, the relevant patent count is effectively:

Scope	Expected active blocking patents
Pyridoxine hydrochloride molecule	0
Conventional oral products	0 material blocking patents expected
Standard injectable product	0 broad blocking patents expected
Narrow formulations or combinations	Product- and jurisdiction-specific
API manufacturing processes	Potentially several historical or process-specific families

Are there Paragraph IV challenges to pyridoxine hydrochloride?

Paragraph IV litigation is not a major feature of the pyridoxine hydrochloride market. The product is an established generic ingredient with no commercially significant, patent-protected reference product requiring a high-value patent challenge.

Generic applicants may use ANDA pathways where a listed reference product exists. However, the absence of valuable active patents reduces the incentive for Paragraph IV litigation. The usual competitive strategy is approval and price-based contracting rather than a patent invalidity campaign.

No material, widely recognized Paragraph IV dispute is central to the current pyridoxine hydrochloride market. Any individual ANDA certification should be reviewed in the FDA Orange Book and associated court records because litigation can attach to a specific formulation, dosage form, or combination product.

What patent litigation affects pyridoxine hydrochloride?

There is no major patent litigation involving the basic pyridoxine hydrochloride molecule comparable to disputes around patented oncology, diabetes, immunology, or biologic products.

The more relevant legal risks are:

• Product liability claims involving overdose or medication error
• Quality claims involving contamination or potency
• False advertising involving supplement disease claims
• cGMP enforcement
• Import and customs actions involving API quality
• Contract disputes involving hospital or distributor supply
• Patent disputes involving combination products or delivery systems

Patent litigation exposure for conventional pyridoxine hydrochloride is low. Regulatory and supply-chain disputes are more commercially relevant.

What formulations are protected by pyridoxine hydrochloride patents?

The highest potential for formulation protection is in products that solve a specific technical problem, such as:

• Improved injectable stability
• Reduced degradation during sterilization
• Compatibility with parenteral nutrition
• Controlled release
• Combination products with other vitamins or minerals
• Pediatric liquid formulations
• Modified delivery systems
• Packaging that limits light or oxygen exposure

These claims are narrow compared with a composition-of-matter patent. Competitors can often design around them by changing concentration, excipients, container materials, release profile, or product combinations.

Standard pyridoxine hydrochloride injection does not require a novel delivery technology. Its competitive requirements are validated sterilization, low particulate burden, consistent assay, acceptable pH, container compatibility, and dependable commercial-scale supply.

How does pyridoxine hydrochloride compare with competing vitamin B6 products?

Pyridoxine hydrochloride competes with other forms of vitamin B6 and with broader vitamin formulations.

Product form	Main advantage	Main limitation	Commercial position
Pyridoxine hydrochloride	Established, soluble, inexpensive	Limited differentiation	Dominant generic pharmaceutical form
Pyridoxal-5'-phosphate	Biologically active coenzyme form in supplement marketing	Higher cost and narrower supply base	Premium supplement niche
Pyridoxine supplements	Low cost, broad availability	Dose and quality vary by channel	Large consumer market
B-complex products	Cross-selling and broad nutritional positioning	High substitution	Retail and online growth channel
Multivitamins	Familiar consumer format	Low ingredient-level differentiation	High-volume, low-margin
Injectable pyridoxine	Useful when oral dosing is not possible	Sterile manufacturing required	Smaller, higher-barrier market

Pyridoxine hydrochloride retains an advantage in pharmaceuticals because it is inexpensive, well characterized, and supported by extensive manufacturing experience. Pyridoxal-5'-phosphate can command higher retail prices but does not generally displace pyridoxine hydrochloride in hospital injection or generic drug applications.

What drives the pyridoxine hydrochloride market?

The market is driven by recurring demand rather than innovation.

Primary growth drivers

1. Expansion of vitamin and wellness supplement sales.
2. Growth in prenatal and multivitamin consumption.
3. Continued use in parenteral nutrition and hospital formularies.
4. Demand from pharmaceutical manufacturers for low-cost API.
5. Food and animal-feed fortification.
6. E-commerce distribution of vitamin products.
7. Use in combination therapies and B-complex products.

Principal constraints

• Very low product differentiation
• Intense price competition
• Limited switching costs
• Dependence on API availability
• Exposure to raw-material and energy costs
• Regulatory scrutiny of supplement claims
• Limited ability to raise prices in standard dosage forms
• Small revenue pool for prescription injection

Consumer demand can grow while supplier revenue remains flat if price competition offsets volume gains. This is typical for mature vitamin ingredients.

What companies manufacture or sell pyridoxine hydrochloride?

The supply base includes:

• Global vitamin and nutrition companies
• Generic injectable manufacturers
• API producers in China and India
• Contract manufacturers
• Private-label supplement companies
• Hospital-product suppliers
• Multivitamin and prenatal-vitamin companies

Representative commercial participants in adjacent vitamin and generic markets include major nutrition companies such as DSM-Firmenich, Lonza, and Balchem, together with numerous Asian API manufacturers and regional generic-drug companies. Participation varies by dosage form and country. A company selling a retail supplement may not manufacture the API, and a large API producer may have no consumer brand.

Supplier diligence should examine:

• FDA registration and inspection history
• Drug Master File or equivalent API documentation
• CEP or other international quality documentation
• Sterile-filling capabilities
• Reserve capacity
• Alternate manufacturing sites
• Audit findings
• Batch-release performance
• Country-of-origin exposure
• Dependence on a single upstream precursor

What is the financial trajectory for pyridoxine hydrochloride?

Pyridoxine hydrochloride has a stable-to-low-growth financial profile at the molecule level. Revenue growth is more likely to come from volume expansion, geographic penetration, premium formulations, or branded supplement positioning than from price increases.

Financial characteristics

Metric	Expected profile
Prescription injection revenue	Small, recurring, price-sensitive
OTC supplement revenue	Larger aggregate market, fragmented
API revenue	Volume-driven and highly competitive
Gross margins	Highest in branded supplements and specialized injectables
Generic tablet margins	Low to moderate
Patent-related profit protection	Minimal
Revenue volatility	Low to moderate, with supply-chain spikes
Pricing power	Weak for standard products
Capital intensity	Moderate for sterile injectables; low to moderate for tablets
Long-term outlook	Stable volume with limited molecule-level expansion

The financial opportunity is strongest in differentiated channels:

• Branded B6 supplements
• Premium coenzyme-form products
• Prenatal and specialty nutrition
• Contract manufacturing
• Sterile injectable supply
• High-quality API with reliable regulatory documentation
• Institutional contracts where supply reliability carries a premium

The weakest opportunity is undifferentiated pyridoxine hydrochloride tablets sold solely on price.

What generic entry risks exist for pyridoxine hydrochloride?

Generic entry risk is already realized rather than prospective. The market has long been exposed to multiple suppliers.

Commercial risks include:

• Rapid price erosion after new approvals
• Substitution among tablet suppliers
• Distributor and pharmacy buying-power concentration
• Loss of hospital contracts
• API qualification delays
• FDA inspection findings
• Sterile-product recalls
• Shortage-driven temporary price increases followed by normalization
• Retail private-label competition

A new entrant can gain share if it offers reliable supply, an approved injectable facility, competitive packaging, or a lower total delivered cost. A standard tablet entrant has limited differentiation and may require scale to produce attractive returns.

Are biosimilar risks relevant to pyridoxine hydrochloride?

No. Pyridoxine hydrochloride is a small-molecule vitamin, not a biologic. Biosimilar pathways do not apply.

The relevant competitors are:

• Generic small-molecule products
• OTC supplements
• Combination vitamins
• Alternative B6 chemical forms
• Hospital nutrition products
• Private-label products

This distinction matters because the market does not have biologic manufacturing complexity, interchangeability disputes, or biosimilar approval barriers. Its regulatory economics are closer to commodity generics and dietary supplements.

What licensing deals affect pyridoxine hydrochloride?

Large licensing transactions are uncommon for conventional pyridoxine hydrochloride. The ingredient is generally sourced through:

• API supply agreements
• Contract manufacturing agreements
• Private-label arrangements
• Hospital purchasing contracts
• Distribution agreements
• Multivitamin formulation partnerships

Licensing value may arise when pyridoxine hydrochloride is included in a proprietary combination, premium supplement, specialty nutrition product, or novel delivery system. The standalone ingredient normally does not justify a meaningful royalty-bearing license because it lacks patent exclusivity and is available from multiple suppliers.

What geographic markets are most important?

The largest commercial regions are North America, Europe, China, India, and other Asian markets with substantial pharmaceutical, nutrition, and supplement production.

Geographic comparison

Region	Market characteristics
United States	Strong supplement demand, FDA-regulated injectable market, concentrated drug purchasing
Europe	Mature pharmaceutical and nutrition markets, extensive quality documentation
China	Major manufacturing base and large domestic market
India	Strong generic-drug and API manufacturing presence
Latin America	Growing supplement and generic demand, import dependence in some markets
Middle East and Africa	Smaller base, greater reliance on imported products and distributors

Geographic risk is driven by regulatory qualification, import controls, currency, freight, and supplier concentration. A manufacturer with dual-region sourcing can reduce disruption risk even without patent protection.

What manufacturing and intellectual-property barriers exist?

The primary barrier for oral products is commercial scale. The primary barrier for injectable products is validated sterile manufacturing.

Important manufacturing requirements include:

• API identity and assay control
• Impurity profiling
• Microbial and endotoxin control
• Sterile processing
• Container closure integrity
• Light and oxygen stability
• Validated sterilization
• Consistent pH and osmolality
• Stability data across shipping conditions
• Traceability and batch documentation

Intellectual property is a secondary barrier. Manufacturing know-how, regulatory history, customer qualification, and facility reliability can protect market share more effectively than patents.

What is the likely generic launch scenario?

For a new conventional tablet or capsule, launch would likely produce limited pricing power and rapid competition. The entrant would need low manufacturing cost, a dependable API source, and established pharmacy or supplement distribution.

For injectable pyridoxine hydrochloride, the market is smaller but entry is more defensible because of sterile-facility requirements and hospital procurement qualification. A successful entrant could secure share through:

• Consistent supply
• Competitive contract pricing
• Multiple vial or ampule presentations
• Strong shortage-management capability
• Reliable FDA compliance
• Distribution through hospital wholesalers

A premium launch based solely on the pyridoxine molecule is unlikely to succeed. A premium based on supply assurance, packaging, pediatric dosing, or an integrated nutrition portfolio has a stronger commercial rationale.

Key Takeaways

• Pyridoxine hydrochloride is a mature vitamin B6 ingredient with no meaningful remaining molecule-level patent protection.
• The FDA market includes prescription injection, OTC products, dietary supplements, pharmaceutical API, and nutrition applications.
• Orange Book and Paragraph IV issues are limited for the conventional ingredient.
• Biosimilar risk is irrelevant because pyridoxine hydrochloride is a small molecule.
• Financial growth depends on volume, supplement branding, sterile injectable supply, and geographic expansion.
• Standard oral products have weak pricing power and high substitution risk.
• Injectable products have better barriers because of sterility, quality, and hospital qualification requirements.
• Manufacturing reliability, regulatory compliance, and distribution are more important than intellectual property.
• Large standalone licensing deals are unlikely; supply and private-label agreements are more common.
• The long-term market outlook is stable, with limited molecule-level revenue growth and selective opportunities in differentiated formulations and regulated injectable supply.

FAQs

Is pyridoxine hydrochloride the same as vitamin B6?

Pyridoxine hydrochloride is a salt form of pyridoxine, one of the chemical forms collectively known as vitamin B6. It is widely used in pharmaceutical and supplement products.

Is pyridoxine hydrochloride a prescription drug or a supplement?

It can be either. Injectable products are prescription drugs, while tablets and capsules may be sold as OTC drugs or dietary supplements depending on their labeling, claims, dosage, and jurisdiction.

Can pyridoxine hydrochloride support a high-margin pharmaceutical product?

The standalone ingredient usually cannot support high margins. Higher margins are more plausible in sterile injectables, branded supplements, proprietary combinations, specialty nutrition, and products with differentiated delivery or packaging.

Does pyridoxine hydrochloride have an orphan-drug opportunity?

The standard ingredient does not have a broad orphan-drug opportunity. A narrowly defined metabolic or deficiency indication could create a separate regulatory strategy, but it would require a distinct product, clinical rationale, and regulatory designation.

What is the main investment risk in pyridoxine hydrochloride?

The main risk is commoditization. Price competition, supplier concentration, quality failures, and loss of distribution can materially affect returns because patent protection does not provide a durable market barrier.

References

1. U.S. Food and Drug Administration. (2023a). Pyridoxine hydrochloride injection prescribing information. FDA-approved labeling.

2. U.S. Food and Drug Administration. (2023b). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

3. U.S. Food and Drug Administration. (2023c). Current good manufacturing practice requirements for finished pharmaceuticals. FDA.

4. U.S. Food and Drug Administration. (2023d). Dietary supplement products and ingredients. FDA.

5. National Institutes of Health, Office of Dietary Supplements. (2023). Vitamin B6 fact sheet for health professionals. National Institutes of Health.

6. World Health Organization. (2022). WHO guideline on good manufacturing practices for pharmaceutical products. World Health Organization.