TEPADINA Drug Patent Profile

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

Tepadina 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 is thiotepa. There are eleven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the thiotepa profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tepadina

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

Summary for TEPADINA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	33
Drug Prices:	Drug price information for TEPADINA
What excipients (inactive ingredients) are in TEPADINA?	TEPADINA excipients list
DailyMed Link:	TEPADINA at DailyMed

See drug prices for TEPADINA

Recent Clinical Trials for TEPADINA

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 clinical trials

Pharmacology for TEPADINA

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

US Patents and Regulatory Information for TEPADINA

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	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	208264-001	Jan 26, 2017	AP	RX	Yes	Yes
Adienne Sa	TEPADINA	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	208264-002	Jan 26, 2017	AP	RX	Yes	Yes
Adienne Sa	TEPADINA AND SODIUM CHLORIDE	thiotepa	POWDER;INTRAVENOUS	208264-003	Apr 10, 2025		RX	Yes	Yes			Y

EU/EMA Drug Approvals for TEPADINA

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

See the table below for patents covering TEPADINA around the world.

Country	Patent Number	Title	Estimated Expiration
China	116211698	多室柔性袋及其使用方法 (Multi-chamber flexible bag and method of use thereof)
Tunisia	2019000260	MULTI CHAMBER FLEXIBLE BAG AND METHODS OF USING SAME
Denmark	3409259
Denmark	3412272

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TEPADINA

Last updated: July 28, 2025

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Introduction

TEPADINA (Tepoxalin), a non-steroidal anti-inflammatory drug (NSAID), has carved a niche in veterinary medicine, primarily used for managing osteoarthritis and pain in dogs. With its unique mechanism inhibiting both COX and lipoxygenase pathways, Tepadina offers advantages over conventional NSAIDs. As it navigates the evolving pharmaceutical landscape, understanding its market dynamics and projected financial trajectory is crucial for stakeholders. This report analyzes the key drivers, competitive environment, regulatory considerations, and future outlooks shaping Tepadina's commercial prospects.

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Market Overview

The global animal health market was valued at approximately USD 45 billion in 2022, with anti-inflammatory drugs comprising a significant segment, driven by the increasing adoption of companion animals and rising awareness of canine osteoarthritis [1]. Veterinary NSAIDs, including Tepadina, are gaining prominence due to their improved safety profiles.

The focus on integrative veterinary pharmacology and the shift toward targeted therapies underpin the demand for agents like Tepadina. While its primary application remains in veterinary pain management, emerging data on its potency and safety may open avenues in broader indications, possibly extending into equine and feline therapeutics.

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Market Drivers

1. Rising Pet Ownership & Awareness

The unprecedented growth in pet ownership, especially post-pandemic, has led to increased expenditure on pet health. According to the American Pet Products Association (APPA), U.S. pet expenditure reached USD 123.6 billion in 2021, with an increasing share allocated for veterinary care [2].

2. Increasing Incidence of Osteoarthritis

Canine osteoarthritis affects approximately 20% of dogs over one year old globally, correlating with aging pet populations [3]. Therapeutics that effectively manage pain with minimal adverse effects are in high demand.

3. Advancements in Veterinary Pharmacology

Innovative drugs like Tepadina, with dual COX and lipoxygenase inhibition, offer enhanced efficacy. Their innovative mode of action aligns with the trend toward personalized and targeted pet therapeutics.

4. Regulatory Support & Approvals

Regulatory bodies, including the FDA in the U.S., have streamlined approval processes for veterinary drugs, facilitating faster market entry for new formulations like Tepadina.

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Competitive Landscape

Tepadina competes with established NSAIDs such as Carprofen, Meloxicam, Firocoxib, and Grapiprant. However, its dual mechanism potentially offers superior efficacy and safety, providing a unique selling proposition.

Key competitors include:

• Carprofen: Historically dominant, with extensive clinical data.
• Meloxicam: Widely used, with a demonstrated safety profile.
• Firocoxib (Previcox): Selective COX-2 inhibitor, popular for chronic use.
• Grapiprant (Galliprant): Targets prostaglandin receptors, reducing GI side effects.

Tepadina’s success hinges on demonstrating clear clinical advantages, safety, and cost-effectiveness to penetrate this market.

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Regulatory & Commercial Challenges

1. Regulatory Approval

Obtaining approvals in multiple jurisdictions is complex. Given the relatively recent emergence of Tepadina, it must pass rigorous safety, efficacy, and manufacturing standards, which can delay commercialization.

2. Patent & Intellectual Property

Protection against generic competition depends on robust patenting. The duration of patent exclusivity directly impacts revenue streams.

3. Pricing & Reimbursement Dynamics

Pricing strategies must balance profitability with affordability for veterinary practices. Reimbursement mechanisms remain limited but could evolve as pet insurance gains traction.

4. Adoption Barriers

Clinicians may prefer well-established NSAIDs; educating stakeholders on Tepadina’s benefits is essential for market penetration.

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Financial Trajectory & Revenue Projections

1. Market Penetration Strategy

Initially targeting regions with high pet ownership and advanced veterinary markets—such as North America, Europe, and Japan—will optimize revenue growth. Early adopters are expected among specialty and referral veterinary clinics.

2. Revenue Estimations

Assuming Tepadina captures 5-10% of the veterinary NSAID market within five years, revenues could reach USD 500-800 million globally (from an estimated USD 45 billion total veterinary market). This assumes a healthy adoption rate driven by clinical effectiveness, safety, and marketing efforts.

3. Pricing Model

Medium-price positioning, approximately USD 10-20 per dose for standard treatment courses, aligns with current veterinary NSAID pricing, optimizing volume and margin.

4. Expansion & Diversification

Future revenues may expand through new formulations (injectables, long-acting preparations), extralabel uses in other species, and adjunct indications such as post-surgical analgesia.

5. Impact of Patent Life & Competition

Patent exclusivity (typically 7-12 years in veterinary drugs) will be crucial in realizing projected revenues. The entry of biosimilars or generics after patent expiry could significantly diminish financial returns.

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Regulatory & Economic Outlook

The trajectory remains promising given the expanding pet health market, coupled with the trend toward targeted, better-tolerated medications. However, impending patent expiries and potential market saturation necessitate innovation and strategic collaboration to sustain financial growth.

Furthermore, increased pet insurance coverage and health care spending are expected to support higher drug adoption rates, bolstering revenues.

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Conclusion

Tepadina enters a promising market characterized by rapid growth, innovation, and evolving consumer preferences. Its dual mechanism offers a competitive edge, and with proper positioning, regulatory approval, and clinical validation, it is poised to attain significant market share. Nonetheless, challenges such as regulatory hurdles, competition, and patent protection must be diligently managed.

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Key Takeaways

• The expanding pet healthcare market and rising pet obesity rates increase demand for effective analgesics like Tepadina.
• The drug’s unique dual inhibition mechanism offers potential differentiation against conventional NSAIDs.
• Success depends on timely regulatory approvals, strategic marketing, and patent protection.
• Revenue projections suggest substantial growth potential, particularly if the drug achieves widespread adoption across key markets.
• Continuous innovation and stakeholder education are vital to maintaining competitive advantage and maximizing financial returns.

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FAQs

1. What is Tepadina, and how does it differ from traditional NSAIDs?
Tepadina (Tepoxalin) uniquely inhibits both cyclooxygenase (COX) and lipoxygenase (LOX) pathways, offering a broader anti-inflammatory effect and potentially reducing GI and cardiovascular side effects associated with traditional NSAIDs that primarily target COX enzymes.

2. What is the current regulatory status of Tepadina globally?
Tepadina has received approval for veterinary use in select markets, notably in some regions of Europe and Asia. Its approval status continues to evolve, with ongoing clinical studies supporting broader regulatory submissions.

3. Which factors could influence Tepadina’s market penetration?
Factors include clinical efficacy, safety profile, regulatory approval speed, veterinarian acceptance, competitive positioning, pricing strategy, and patent protection.

4. How significant is the pet owner’s willingness to adopt new therapies like Tepadina?
Pet owners are increasingly willing to invest in advanced therapies, especially when backed by strong clinical evidence. Educational initiatives targeting veterinarians and pet owners will be critical in driving adoption.

5. What are the potential risks impacting Tepadina’s financial trajectory?
Risks encompass regulatory delays, patent expiration, market competition from established NSAIDs, safety concerns, and shifts in veterinary prescribing habits.

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References

[1] Statista, “Global Animal Health Market Size,” 2022.
[2] American Pet Products Association, "2021-2022 APPA National Pet Owners Survey," 2022.
[3] Veterinary Medicine Journal, “Incidence of Osteoarthritis in Dogs,” 2021.