GUANIDINE HYDROCHLORIDE - Generic Drug Details
What are the generic sources for guanidine hydrochloride and what is the scope of patent protection?
Guanidine hydrochloride
is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. Additional information is available in the individual branded drug profile pages.Summary for GUANIDINE HYDROCHLORIDE
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 132 |
| Clinical Trials: | 8 |
| Patent Applications: | 6,776 |
| What excipients (inactive ingredients) are in GUANIDINE HYDROCHLORIDE? | GUANIDINE HYDROCHLORIDE excipients list |
| DailyMed Link: | GUANIDINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for GUANIDINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Children's Hospital of Fudan University | Phase 4 |
| Washington University School of Medicine | Early Phase 1 |
| St. Louis University | Early Phase 1 |
US Patents and Regulatory Information for GUANIDINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | GUANIDINE HYDROCHLORIDE | guanidine hydrochloride | TABLET;ORAL | 001546-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Guanidine Hydrochloride Market Dynamics and Financial Trajectory
Guanidine hydrochloride is a mature chemical compound with limited direct pharmaceutical commercialization. It has historical use in neuromuscular disorders, particularly Lambert-Eaton myasthenic syndrome (LEMS), but it is not the active ingredient in the principal FDA-approved LEMS product. Current demand is concentrated in laboratory reagents, biotechnology manufacturing, chemical synthesis and specialty industrial applications rather than branded prescription medicine.
No publicly reported pharmaceutical revenue stream, active branded product franchise, Orange Book exclusivity position or meaningful standalone drug-market forecast has been identified for guanidine hydrochloride. Its commercial economics are driven by commodity and specialty-chemical supply factors, not by pharmaceutical patent pricing.
Is guanidine hydrochloride an FDA-approved drug?
Guanidine hydrochloride is not an FDA-approved standalone prescription drug with a current branded product in the U.S. market. It is a chemical compound used in laboratory, biochemical and industrial settings and has historical medical use as an oral agent for neuromuscular transmission disorders.
The FDA-approved LEMS therapy is Firdapse, whose active ingredient is amifampridine phosphate, not guanidine hydrochloride. Firdapse received FDA approval in 2018 for adults with LEMS and is marketed by Catalyst Pharmaceuticals.[1]
| Attribute | Guanidine hydrochloride | Firdapse |
|---|---|---|
| Active ingredient | Guanidine hydrochloride | Amifampridine phosphate |
| Principal medical use | Historical or off-label neuromuscular use | Lambert-Eaton myasthenic syndrome |
| FDA approval | No current standalone FDA-approved product identified | Approved in 2018 |
| Regulatory category | Chemical and specialty reagent | Prescription orphan drug |
| Orange Book commercial position | No meaningful branded listing identified | Listed drug with approved labeling |
| Patent-driven pricing | Limited | Material |
| Public product revenue | No standalone disclosure | Reported by Catalyst Pharmaceuticals |
Guanidine hydrochloride has been used historically to improve neuromuscular transmission by increasing acetylcholine release at the neuromuscular junction. Its use is constrained by toxicity, including renal effects, gastrointestinal effects, hematologic complications and dose-limiting tolerability concerns. Amifampridine displaced guanidine in the modern LEMS treatment pathway because of a more favorable regulatory and commercial profile.[2]
What is the current pharmaceutical market for guanidine hydrochloride?
The direct pharmaceutical market is small and fragmented. Guanidine hydrochloride is primarily sold as a chemical or laboratory product rather than as a finished prescription medicine.
Primary demand segments
| Segment | Commercial role | Market characteristics |
|---|---|---|
| Biochemical research | Protein denaturant and chaotropic reagent | Sold in research-grade and molecular-biology grades |
| Pharmaceutical manufacturing | Process reagent or synthesis input | Demand depends on contract manufacturing and API production |
| Chemical synthesis | Intermediate or reagent | Price-sensitive, with multiple suppliers |
| Industrial applications | Specialty chemical input | Volume and margin vary by purity and application |
| Human therapeutics | Historical neuromuscular use | Limited, non-branded and commercially immaterial |
Guanidine hydrochloride is widely used as a chaotropic agent in protein purification and nucleic-acid workflows. It is also associated with guanidinium-based chemistry used in molecular biology and analytical laboratories. These applications create a broader addressable market than human therapeutics, but they do not support drug-like pricing.
The product is commonly available from laboratory suppliers and chemical manufacturers in multiple grades, including reagent, molecular-biology, analytical and industrial grades. Specification, purity, packaging, documentation and regulatory support determine price differences more than patent exclusivity.
How large is the guanidine hydrochloride drug market?
No reliable public estimate supports a material standalone pharmaceutical market for guanidine hydrochloride. Public company filings generally do not report revenue from guanidine hydrochloride as a separate product category.
The practical market assessment is:
- Finished-dose prescription demand is negligible relative to approved LEMS therapies.
- Hospital and specialty-pharmacy demand is not organized around a branded guanidine hydrochloride product.
- Laboratory and industrial sales represent the commercially relevant market.
- Supplier revenue is usually reported within broader reagent, life-science or specialty-chemical categories.
- Market forecasts that assign a large pharmaceutical value to guanidine hydrochloride may be conflating the compound with guanidine derivatives, guanidinium reagents or LEMS medicines.
This distinction is important for valuation. A company selling guanidine hydrochloride as a reagent has a chemicals business model. A company seeking to commercialize guanidine hydrochloride as a prescription treatment would face a different regulatory, safety and reimbursement profile.
What is the financial trajectory for guanidine hydrochloride?
There is no identifiable standalone pharmaceutical financial trajectory. The compound does not have the characteristics of a growing branded drug franchise.
Commercial trajectory
| Period | Market condition | Financial implication |
|---|---|---|
| Historical period | Medical use existed for neuromuscular disorders | Limited demand, constrained by toxicity |
| Modern LEMS period | Amifampridine became the approved treatment pathway | Further reduced commercial relevance of guanidine |
| Current market | Reagent, research and industrial sales dominate | Commodity or specialty-chemical economics |
| Forward outlook | Stable niche demand tied to biotechnology and chemical production | Volume growth may occur without drug-like margins |
Guanidine hydrochloride pricing is likely to track:
- Raw-material and energy costs
- Manufacturing capacity in China and other Asian markets
- Purity requirements
- Freight and packaging
- Quality-control documentation
- Pharmaceutical or laboratory-grade certification
- Contract-manufacturing demand
- Supply-chain disruptions affecting specialty chemicals
Margin expansion from patent protection is unlikely. Suppliers compete through scale, quality, availability, regulatory documentation and customer qualification. Switching costs may be meaningful for validated pharmaceutical or analytical processes, but they are generally customer-specific rather than protected by an exclusive drug patent.
What patents protect guanidine hydrochloride?
The basic guanidine hydrochloride molecule is an old compound and is not a credible target for new composition-of-matter exclusivity. Any original composition patent would have expired long ago.
Potential intellectual-property protection may instead relate to:
- Manufacturing processes
- Purification methods
- Crystal form or particle characteristics
- Formulated laboratory compositions
- Combination products
- Specific medical methods
- New uses of guanidine derivatives
- Packaging or stabilization systems
These categories do not create a broad, molecule-level monopoly over guanidine hydrochloride.
Patent strength
| IP category | Likely strength | Commercial impact |
|---|---|---|
| Basic compound patent | None for modern commercialization | No exclusivity |
| Standard pharmaceutical composition | Low | Easy substitution if formulation is conventional |
| Manufacturing process | Moderate if cost-saving or difficult to design around | May protect supplier economics |
| Purity or specification process | Moderate | Can support qualified-supplier status |
| Method of use | Potentially narrow | Depends on clinical evidence and claim scope |
| Combination product | Potentially stronger | Relevant only to a defined therapeutic product |
| Laboratory formulation | Usually narrow | Protects a specific use or package, not the compound broadly |
What is the Orange Book status of guanidine hydrochloride?
No material Orange Book position is associated with guanidine hydrochloride as a standalone prescription product. The Orange Book is relevant to approved drug products, listed patents and exclusivity associated with those products. Guanidine hydrochloride does not have the commercial profile of an Orange Book-listed branded medicine.[3]
Firdapse has a separate regulatory and patent position because its active ingredient is amifampridine phosphate. That position should not be attributed to guanidine hydrochloride.
The absence of an Orange Book position means:
- There is no identified branded reference product for an ANDA-based generic challenge.
- There is no conventional Paragraph IV target for guanidine hydrochloride itself.
- Generic-entry analysis is largely irrelevant unless a sponsor develops and obtains approval for a new prescription formulation.
- Patent litigation risk is more likely to involve a derivative, formulation or method-of-use product than the base chemical.
When does guanidine hydrochloride lose exclusivity?
Guanidine hydrochloride has no meaningful current pharmaceutical exclusivity period to expire. The underlying compound is old, and any historical composition protection is presumed expired.
The relevant commercial barriers are regulatory and operational rather than exclusivity-based:
- Clinical development and FDA approval for a new therapeutic indication
- Demonstration of safety and efficacy
- Manufacturing quality systems
- Finished-dose formulation
- Stability and impurity control
- Clinical supply and pharmacovigilance
- Physician acceptance relative to amifampridine
- Payer coverage and reimbursement
A new formulation or therapeutic use could receive patents or regulatory exclusivity, but that protection would attach to the new product or use, not to guanidine hydrochloride as a chemical substance.
Are there Paragraph IV challenges involving guanidine hydrochloride?
No significant Paragraph IV litigation involving a standalone guanidine hydrochloride product has been identified. Paragraph IV litigation requires an ANDA applicant to challenge patents listed for an approved reference drug. Guanidine hydrochloride lacks the established branded reference-product structure normally associated with this process.
A future sponsor could create Paragraph IV exposure by developing a novel approved product containing guanidine hydrochloride. The risk would then depend on:
- Whether patents are listed for the reference product
- The claims directed to formulation or method of use
- The ANDA applicant's certification
- The timing of patent expiration
- Settlement terms
- The availability of non-infringing alternatives
What generic entry risks exist for guanidine hydrochloride?
For laboratory and industrial guanidine hydrochloride, generic-entry risk is already embedded in the market. Multiple suppliers can manufacture chemically equivalent material, subject to grade, purity and customer qualification.
For a future prescription product, the risk would be substantial because:
- The active molecule is old.
- Composition-of-matter protection is unavailable.
- Formulation claims may be designed around.
- A conventional oral dosage form would likely face rapid competition after approval.
- Physician familiarity with amifampridine could limit market uptake.
- Toxicity could restrict premium pricing and payer acceptance.
A sponsor would need differentiated clinical value, a defensible formulation or a narrowly defined orphan indication to support a commercial return.
How does guanidine hydrochloride compare with amifampridine?
Amifampridine has the stronger pharmaceutical position by a wide margin.
| Factor | Guanidine hydrochloride | Amifampridine |
|---|---|---|
| Regulatory status | No current standalone FDA drug approval identified | FDA-approved for LEMS |
| Clinical role | Historical or off-label | Current approved treatment |
| Safety profile | Toxicity limits use | Established approved dosing and labeling |
| Patent potential | Limited for base compound | Drug, formulation and use claims may apply |
| Commercial model | Reagent and specialty chemical | Branded orphan drug |
| Pricing power | Low | Higher, subject to reimbursement and competition |
| Revenue visibility | No standalone disclosure | Reported through Catalyst Pharmaceuticals |
| Generic risk | Commodity substitution already present | ANDA and patent-litigation risk |
The comparison shows why guanidine hydrochloride should not be valued using the revenue multiple or exclusivity assumptions applicable to Firdapse.
What licensing deals and litigation affect guanidine hydrochloride?
No major licensing transaction, settlement agreement or branded-drug litigation centered on guanidine hydrochloride has been identified as a material market event.
The relevant commercial transactions are more likely to be:
- Supply agreements
- Contract-manufacturing arrangements
- Distributor relationships
- Laboratory reagent catalog agreements
- Qualified-supplier contracts
- Private-label chemical sales
These agreements are rarely disclosed at the individual-product level. Their value is generally linked to volume, purity, delivery requirements and customer qualification rather than patent royalties.
Litigation risk may arise from product quality, contamination, supply failure, regulatory compliance or contract performance. Patent litigation is unlikely to be the primary risk for the base compound.
What is the competitive landscape?
Competition is fragmented. Suppliers may include laboratory-reagent companies, chemical manufacturers, contract manufacturers and distributors. The competitive variables are:
- Assay and impurity profile
- Batch consistency
- Pharmaceutical or analytical documentation
- Packaging and storage
- Manufacturing scale
- Lead times
- Geographic redundancy
- Customer qualification
- Price
Geographic concentration can affect availability. Asian manufacturing capacity is important across specialty chemicals, while North American and European distributors provide local inventory, documentation and technical support. Pharmaceutical-grade customers may maintain approved supplier lists, creating moderate switching costs even where patents are absent.
What manufacturing and IP barriers exist?
The manufacturing process is chemically mature, but pharmaceutical and laboratory customers may require controlled impurity profiles, validated analytical methods and detailed quality documentation. Those requirements can create practical barriers to entry.
The strongest defensible positions are likely to come from:
- Reliable high-purity production
- Validated GMP manufacturing
- Consistent lot performance
- Low levels of trace metals and organic impurities
- Secure regional supply
- Regulatory documentation
- Process economics
- Customer-specific qualification
These barriers support supplier retention but do not create molecule-wide exclusivity.
Key Takeaways
- Guanidine hydrochloride has limited direct pharmaceutical commercialization.
- It is not the active ingredient in FDA-approved Firdapse, which contains amifampridine phosphate.
- No material standalone Orange Book position, Paragraph IV dispute or branded prescription franchise has been identified.
- The base compound is old and has no credible modern composition-of-matter patent position.
- Current commercial demand is concentrated in biotechnology, laboratory reagents, chemical synthesis and specialty manufacturing.
- Public companies do not generally disclose guanidine hydrochloride revenue separately.
- Financial performance depends on volume, purity, manufacturing cost and supply reliability rather than patent-protected pricing.
- A new therapeutic product would face substantial clinical, safety, differentiation and generic-entry risks.
- Guanidine hydrochloride should be valued as a specialty chemical unless a defined approved formulation, clinical program or licensing asset is under review.
FAQs
Is guanidine hydrochloride the same drug as Firdapse?
No. Firdapse contains amifampridine phosphate. Guanidine hydrochloride is a separate compound with historical use in neuromuscular disorders.
Can guanidine hydrochloride be sold as a prescription drug without FDA approval?
No. A company marketing it as a prescription treatment in the United States would generally need an applicable FDA-approved drug pathway, unless operating within a legally recognized exemption.
Does guanidine hydrochloride have orphan-drug exclusivity?
No current orphan-drug exclusivity associated with guanidine hydrochloride as a standalone FDA-approved product has been identified.
Is guanidine hydrochloride a good pharmaceutical licensing asset?
By itself, it is a weak pharmaceutical licensing asset. Its value would depend on a differentiated formulation, new clinical evidence, proprietary manufacturing process or an approved indication.
What would increase the value of a guanidine hydrochloride business?
Value could increase through GMP-grade production, validated high-purity supply, long-term customer contracts, regional manufacturing redundancy, proprietary processing and a clinically differentiated finished-dose product.
References
- Catalyst Pharmaceuticals, Inc. (2018). Firdapse (amifampridine) prescribing information. U.S. Food and Drug Administration.
- U.S. National Library of Medicine. (n.d.). Guanidine: Drug information and pharmacology. DrugBank and related biomedical references.
- U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugsatfda
- National Center for Biotechnology Information. (n.d.). PubChem compound summary: Guanidine hydrochloride. PubChem. https://pubchem.ncbi.nlm.nih.gov/
- U.S. Food and Drug Administration. (2018). FDA approves first treatment for Lambert-Eaton myasthenic syndrome. https://www.fda.gov/
More… ↓
