TEPADINA AND SODIUM CHLORIDE Drug Patent Profile

Which patents cover Tepadina And Sodium Chloride, and what generic alternatives are available?

Tepadina And Sodium Chloride is a drug marketed by Adienne Sa and is included in one NDA. There is one patent protecting this drug.

The generic ingredient in TEPADINA AND SODIUM CHLORIDE is thiotepa. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the thiotepa profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tepadina And Sodium Chloride

A generic version of TEPADINA AND SODIUM CHLORIDE was approved as thiotepa by WEST-WARD PHARMS INT on April 2^nd, 2001.

Summary for TEPADINA AND SODIUM CHLORIDE

US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	33
DailyMed Link:	TEPADINA AND SODIUM CHLORIDE at DailyMed

Recent Clinical Trials for TEPADINA AND SODIUM CHLORIDE

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

Sponsor	Phase
City of Hope Medical Center	Phase 1
Fred Hutchinson Cancer Center	Phase 2
National Cord Blood Network	Phase 2

See all TEPADINA AND SODIUM CHLORIDE clinical trials

Pharmacology for TEPADINA AND SODIUM CHLORIDE

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

US Patents and Regulatory Information for TEPADINA AND SODIUM CHLORIDE

TEPADINA AND SODIUM CHLORIDE is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Adienne Sa	TEPADINA AND SODIUM CHLORIDE	thiotepa	POWDER;INTRAVENOUS	208264-003	Apr 10, 2025		RX	Yes	Yes			Y
Adienne Sa	TEPADINA AND SODIUM CHLORIDE	thiotepa	POWDER;INTRAVENOUS	208264-004	Jan 15, 2026		RX	Yes	Yes			Y

EU/EMA Drug Approvals for TEPADINA AND SODIUM CHLORIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
ADIENNE S.r.l. S.U.	Tepadina	thiotepa	EMEA/H/C/001046In combination with other chemotherapy medicinal products:with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.". It is proposed that Tepadina must be prescribed by physicians experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation.	Authorised	no	no	no	2010-03-15
Esteve Pharmaceuticals GmbH	Thiotepa Riemser	thiotepa	EMEA/H/C/005434Thiotepa Riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.Thiotepa Riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients	Authorised	yes	no	no	2021-03-26

International Patents for TEPADINA AND SODIUM CHLORIDE

See the table below for patents covering TEPADINA AND SODIUM CHLORIDE around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	111984	BOLSA FLEXIBLE CON MÚLTIPLES CÁMARAS Y MÉTODOS PARA USARLA
Argentina	129712	BOLSA FARMACÉUTICA FLEXIBLE CON MÚLTIPLES CÁMARAS Y MÉTODO PARA PREPARAR UN PRODUCTO FARMACÉUTICO EN ELLA
Australia	2017261511	Multi chamber flexible bag and methods of using same
Brazil	102018002480	bolsa flexível de múltiplas câmaras e métodos de uso da mesma
Canada	2985042	SAC FLEXIBLE MULTI COMPARTIMENT ET METHODES D'UTILISATION ASSOCIEES (MULTI CHAMBER FLEXIBLE BAG AND METHODS OF USING SAME)
Chile	2019003159	Bolsa flexible multicámara y métodos de uso de la misma.

Last updated: June 28, 2026

Tepadina and Sodium Chloride Market Dynamics and Financial Trajectory: Sales Drivers, Price Pressure, and Revenue Outlook

Tepadina is marketed with sodium chloride as a diluent in injectable preparations. Market dynamics are dominated by (1) competition from established IV-administered generics and branded hospital injectables, (2) hospital formulary controls and tendering, (3) working-capital and supply-chain stability for sterile manufacturing, and (4) patent and regulatory barrier timing that determines generic substitution speed. Financial trajectory depends on share stability through tender cycles, margin compression from competitive bidding, and conversion of inpatient use into repeat institutional contracts.

What is tepadina and sodium chloride and where does it fit in the drug market?

Tepadina in hospital settings is positioned as an injectable product where sodium chloride functions as the isotonic carrier/diluent used for administration. The market behaves like other sterile injectable franchises: buyers are institutional, procurement is tender-driven, and unit economics hinge on acquisition cost, sterile fill-finish margins, and pass-through of regulatory and quality costs.

Which therapeutic category and customer segment does it serve?

• Therapeutic use: inpatient and acute-care administration typical of IV injectable brands.
• Primary customers: hospitals, regional health systems, and group purchasing organizations (GPOs).
• Purchase mechanism: tenders, contract renewals, and emergency stocking contracts.

What delivery system and regulatory profile matter for commercial performance?

• Dosage form: injectable (sterile).
• Packaging and logistics: cold-chain requirements, if any, and stability specs drive distribution economics.
• Competitive set: branded sterile injectables plus authorized and non-authorized generics where available.

How do hospital tendering and formulary controls shape tepadina sodium chloride sales?

Hospital systems purchase primarily through:

• Formulary placement and step edits (preferred vs restricted listing)
• Tender pricing for 6 to 18 month contracting windows
• Volume commitments that trade off price vs supply guarantees

Key market dynamics that compress revenue

• Tender price resets: branded products face recurring price pressure when generics or therapeutically equivalent alternatives enter or when contracts re-open.
• Mix shift: use can move toward lowest net-price offers within therapeutically substitutable classes.
• Contract leakage: if supply reliability dips, clinicians and procurement can shift volume even without formal formulary changes.
• International purchasing variance: cross-country procurement rules can create discontinuous demand and uneven revenue patterns.

Pricing mechanics that determine net sales

• Discounting is contract-driven. List price is less informative than contract net price, rebate structures, and freight/handling terms.
• Sterile manufacturing cost structure can prevent rapid price cuts, leading to margin squeeze instead of volume protection.

What pricing power does tepadina sodium chloride have versus generics and branded competitors?

Pricing power is typically strongest when:

• No close generic competition exists on the same strength, fill, and packaging configuration.
• The product is the preferred option in a key clinical protocol.
• Supply assurance and clinician familiarity reduce switching.

Pricing power erodes when:

• Authorized generics or therapeutic equivalents gain tender placements.
• Multiple suppliers enter the same hospital contract.
• Pharmacy and therapeutics committees adopt narrower criteria that favor lower acquisition cost.

When does tepadina sodium chloride lose exclusivity or face generic substitution risk?

Generic substitution risk is determined by:

• Patent estate expiry (composition, formulation, method-of-use, and process where applicable)
• Regulatory exclusivities (where relevant to the reference product or related approvals)
• Actual market availability timing: supply readiness often gates generic uptake.

Key commercial implication: revenue tends to be front-loaded pre-competition and then steps down after tender cycles that incorporate new supply at lower net pricing.

What patents protect tepadina and sodium chloride, and how does that affect the revenue curve?

For revenue forecasting, the market impact is tied to whether exclusivity relates to:

• The active pharmaceutical ingredient (API) itself
• The specific formulation (including diluent/sterile formulation)
• Manufacturing processes that are hard to replicate
• Clinical method-of-use claims that restrict prescribing

Revenue trajectory linkage:

• If formulation/process patents persist after composition expiry, branded products can delay full price erosion.
• If only method-of-use claims exist and are weakly enforced, generics can still substitute for most use cases, driving rapid net price declines.

What is the Orange Book status of tepadina sodium chloride and how many listings matter?

Orange Book status controls the “paper barrier” for ANDA-led competition. The commercial risk is highest when:

• Multiple Orange Book-listed patents are not listed for the challenged NDA/BLA relationship.
• Settlement agreements permit “at-risk” launch outside the most protective claims.
• The listed patents are expiring soon relative to the current contract procurement cycle.

Featured-snippet answer: market risk accelerates when Orange Book-listed patents tied to the marketed product expire within the time window of the next major institutional tenders.

How do FDA approval pathways influence the financial trajectory for tepadina sodium chloride?

For sterile injectables, competitive entry timing typically depends on:

• ANDA approvals for therapeutically equivalent versions
• Labelling match and interchangeability acceptance in hospital formularies
• Stability and shelf-life equivalence that supports bulk stocking

What generic entry risks exist for tepadina sodium chloride?

• ANDA approval with rapid label equivalence
• Tender-driven switching even before full market maturity if hospitals can source reliably
• Contracting decisions that favor the lowest net price across multiple brands and generics simultaneously

What patent litigation affects tepadina sodium chloride and settlement timing?

Patent litigation drives the “delay window” that shapes revenue protection and the timing of generic pricing pressure. The main commercial outcomes:

• No settlement: generic entry can occur once statutory triggers are met, creating step-down revenue.
• Early settlement: branded may trade exclusivity with a settlement payment in exchange for delayed entry.
• Carve-outs: settlements can permit limited generics to enter certain strengths, pack sizes, or distribution channels first.

Which companies supply tepadina sodium chloride, and how concentrated is the competitive landscape?

Concentration determines the speed of pricing changes:

• High concentration of branded supply can support steadier net pricing.
• Multi-supplier competition reduces net price and raises promotional intensity (rebate and tender bids).

Commercial implications of supplier concentration

• Single-source constraints can increase demand reliability but also limit volume.
• Multi-source availability increases tender competitiveness and accelerates price compression.

How does tepadina sodium chloride compare with similar injectable products in market behavior?

Sterile injectable analogs typically show:

• Lower growth than chronic therapies due to limited patient population expansion
• Volatile demand from hospital mix and protocols
• Margin compression after generic entry
• Revenue stability when brand is locked into routine inpatient pathways and procurement agreements

What does the financial trajectory look like under a tender-cycle model?

A realistic financial shape for hospital injectables:

1. Pre-competition period: revenue growth or flat performance driven by contract renewals and stable net pricing.
2. Competitive entry lead time: volume may remain stable initially, but net price declines appear at the next contract reset.
3. Post-entry phase: sustained revenue erosion via net price reduction, partially offset by volume gains if tender includes multiple suppliers.

What metrics should govern forecasting?

• Net sales by hospital group and geography
• Unit sales and ASP (average selling price) trends at contract level
• Contract renewal timing and share loss events
• Inventory turn and fill-finish capacity utilization for sterile production

What revenue exposure exists if generic entry accelerates for tepadina sodium chloride?

Revenue exposure is driven by:

• Brand share in contracted accounts
• Strength and pack configurations that match generic offerings
• Probability of switching barriers (clinical preference, compatibility concerns, pharmacy protocols)

Revenue risk pattern:

• Highest near expiry of exclusivity or after favorable ANDA approvals.
• Often material in the 6 to 12 months after generic approvals once contracts reset.

How strong is the patent estate for tepadina sodium chloride as a business barrier?

Patent strength translates into commercial duration only if:

• Claims cover the actually marketed product configuration.
• Enforced patents are listed and mapped to the ANDA/Biologic License Application reference relationship.
• Settlements prevent early design-around or launch.

For business planning, “weak enforcement” manifests as:

• Short delay windows
• Rapid net pricing erosion regardless of remaining claims
• Higher litigation cost with limited incremental revenue protection

Key Takeaways

• Tepadina with sodium chloride is a sterile injectable hospital product where revenue trajectory is driven by tendering, contract renewals, and switching risk.
• Net price compression is the dominant financial driver once therapeutically equivalent competition gains tender placements.
• Patent estate and Orange Book listings matter only when they map to the marketed configuration and translate into enforceable delays for ANDA-led entry.
• Forecasting accuracy depends on aligning generic entry and exclusivity events with the next procurement and contract reset cycle, not only with filing or approval dates.
• The post-entry phase is typically characterized by step-down net sales and sustained margin compression, with partial offset only if volume holds through multi-source contracting.

FAQs

1. How do hospital tenders change net pricing for sterile injectables like tepadina with sodium chloride?
   Contract resets and rebate structures drive net price faster than list price, typically causing stepwise ASP declines.

2. What determines whether a generic for a sodium chloride-containing injectable gets accepted by hospital formularies?
   Label equivalence, stability/shelf-life, supply reliability, and procurement policy determine uptake.

3. Can method-of-use or process patents meaningfully delay substitution for injectable products?
   Yes only when they restrict prescribing or when process claims block practical supply, but composition expiry often drives faster erosion.

4. What is the typical time lag between FDA ANDA approval and measurable revenue impact in hospital injectables?
   The impact usually shows at the next contract/tender cycle when procurement swaps to lower net price supply.

5. How does multi-sourcing affect pricing dynamics after generic entry?
   Multi-supplier tender competition accelerates price compression and reduces the brand’s ability to hold share on net price.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. ANDA Drug Approval. U.S. Food and Drug Administration.
3. FDA. Drug Safety and Availability: Drug Shortages. U.S. Food and Drug Administration.