CASSIPA Drug Patent Profile

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

Cassipa is a drug marketed by Teva Pharms Usa and is included in one NDA.

The generic ingredient in CASSIPA is buprenorphine hydrochloride; naloxone hydrochloride. There is one drug master file entry for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cassipa

A generic version of CASSIPA was approved as buprenorphine hydrochloride; naloxone hydrochloride by ACTAVIS ELIZABETH on February 22^nd, 2013.

Summary for CASSIPA

US Patents:	0
Applicants:	1
NDAs:	1
DailyMed Link:	CASSIPA at DailyMed

US Patents and Regulatory Information for CASSIPA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa	CASSIPA	buprenorphine hydrochloride; naloxone hydrochloride	FILM;SUBLINGUAL	208042-001	Sep 7, 2018		DISCN	Yes	No

CASSIPA Market Dynamics, Patent Position, and Financial Trajectory

Last updated: August 2, 2026

Cassipa is Indivior PLC’s buprenorphine and naloxone sublingual film for maintenance treatment of opioid use disorder. Its commercial position is constrained by generic buprenorphine/naloxone films, established Suboxone substitution, and long-acting injectable competitors such as Sublocade and Brixadi. Cassipa does not have a separately disclosed revenue line in Indivior’s public financial statements, so its financial trajectory must be assessed through product-level market data, prescription trends, pricing, formulary access, and the broader Suboxone franchise.

What is Cassipa and how does it work?

Cassipa contains buprenorphine and naloxone in a sublingual film. Buprenorphine is a partial opioid agonist used to reduce withdrawal and opioid cravings. Naloxone is included to reduce misuse by injection.

The product is administered under the tongue and is intended for maintenance treatment after induction and dose stabilization. Cassipa is a small-molecule drug, not a biologic. Biosimilar regulation therefore does not apply. Competitive entry occurs through abbreviated new drug applications, or ANDAs, and conventional generic substitution.

Product	Active ingredients	Dosage form	Company	Regulatory pathway
Cassipa	Buprenorphine/naloxone	Sublingual film	Indivior	505(b)(2)/NDA
Suboxone Film	Buprenorphine/naloxone	Sublingual film	Indivior	NDA
Generic buprenorphine/naloxone film	Buprenorphine/naloxone	Sublingual film	Multiple generic manufacturers	ANDA
Zubsolv	Buprenorphine/naloxone	Sublingual tablet	Orexo	NDA
Sublocade	Buprenorphine	Extended-release injection	Indivior	NDA
Brixadi	Buprenorphine	Extended-release injection	Braeburn/shire?	NDA

Cassipa is differentiated primarily by formulation, dosage presentation, and commercial positioning rather than by a new active pharmaceutical ingredient.

When did Cassipa receive FDA approval and launch?

The FDA approved Cassipa in September 2018 for maintenance treatment of opioid dependence as part of a complete treatment plan that includes counseling and psychosocial support.[1]

Cassipa entered a mature buprenorphine/naloxone market. Suboxone had already established the sublingual film category, while generic tablets and films were gaining formulary access. Cassipa therefore faced a limited opportunity to create a large independent franchise.

Cassipa regulatory timeline

Event	Date
FDA approval	September 2018
U.S. commercial availability	2018
Market category	Buprenorphine/naloxone maintenance treatment
Product type	Small-molecule combination film
Biosimilar pathway	Not applicable
Primary competitive risk	Generic film and tablet substitution
Long-acting alternatives	Sublocade and Brixadi

The product’s commercial relevance depends on access through Medicaid, managed-care plans, specialty pharmacies, opioid treatment programs, and office-based addiction-treatment practices.

What patents protect Cassipa?

Cassipa’s protection is based on product and formulation rights surrounding buprenorphine/naloxone sublingual films. The relevant patent estate overlaps with the broader Indivior Suboxone film franchise. Patent analysis must distinguish between:

1. Patents listed specifically against Cassipa in the FDA Orange Book.
2. Patents covering buprenorphine/naloxone films more broadly.
3. Method-of-use patents covering opioid-dependence treatment.
4. Manufacturing and drug-delivery patents that may create practical barriers even after composition claims expire.

The FDA Orange Book is the controlling public source for listed patents and regulatory exclusivity.[2] Cassipa’s commercial protection is weaker than a novel chemical entity because the active ingredients were already established, and generic applicants can challenge patents through Paragraph IV certifications.

What is the Orange Book status of Cassipa?

Cassipa is an approved NDA product, but its Orange Book position should be evaluated separately from Suboxone Film. A patent listed for one NDA does not automatically create identical protection for another NDA unless the relevant claims and listing apply to that product.

The key commercial point is that Cassipa does not rely on a long new-chemical-entity exclusivity period. Its protection is primarily patent-based and vulnerable to ANDA litigation, patent invalidity claims, non-infringement arguments, and formulation workarounds.

Publicly disclosed Indivior litigation has focused heavily on the broader Suboxone film product and related patents. That litigation shaped the timing of generic film entry and the economics of the buprenorphine/naloxone market.[3]

When does Cassipa lose exclusivity?

Cassipa’s exclusivity is not defined by one simple date. The relevant timing depends on FDA-listed patents, pediatric exclusivity, regulatory exclusivity, litigation outcomes, and whether a generic applicant obtains a favorable court decision or settlement entry date.

Exclusivity components

Exclusivity type	Cassipa relevance
New chemical entity exclusivity	Not available because buprenorphine and naloxone were previously approved
Five-year NCE period	Not applicable
Three-year clinical-investigation exclusivity	Potentially relevant only to qualifying new clinical data and approval scope
Pediatric exclusivity	Depends on an FDA-granted pediatric extension
Patent exclusivity	Product, formulation, method, and manufacturing patents
Orphan exclusivity	Not applicable
Biosimilar exclusivity	Not applicable

Cassipa’s practical loss of exclusivity has already occurred in the broader therapeutic category because generic buprenorphine/naloxone products are available. The remaining question is not whether competition can enter the molecule class, but how much substitution reaches the specific Cassipa dosage form and prescribing channel.

Which companies are challenging Cassipa and the buprenorphine/naloxone film market?

The principal competitive pressure comes from generic manufacturers rather than from a single branded challenger. Generic buprenorphine/naloxone films and tablets are marketed by companies including Dr. Reddy’s Laboratories, Alvogen, Sandoz, Hikma, Amneal, and other approved ANDA holders, depending on product strength and market period.

The competitive set also includes:

• Suboxone Film, Indivior’s principal branded reference product.
• Zubsolv, Orexo’s sublingual tablet.
• Generic buprenorphine/naloxone tablets.
• Sublocade, Indivior’s monthly extended-release buprenorphine injection.
• Brixadi, an extended-release buprenorphine injection approved in 2023.
• Methadone, particularly in opioid treatment programs.

How does Cassipa compare with Suboxone?

Suboxone has greater brand recognition, historical prescriber familiarity, and payer presence. Cassipa has limited ability to displace Suboxone because the products address the same treatment population and share the same active ingredients.

Factor	Cassipa	Suboxone Film
Active ingredients	Buprenorphine/naloxone	Buprenorphine/naloxone
Delivery	Sublingual film	Sublingual film
Brand history	Later entrant	Category leader
Generic exposure	High	High
Prescriber familiarity	Lower	Higher
Standalone financial disclosure	No	Included in Indivior reporting
Strategic role	Secondary film brand	Core legacy franchise

Cassipa’s commercial role is therefore more likely to be defensive or complementary than transformational.

What patent litigation affects Cassipa and Suboxone?

Indivior has historically litigated extensively to protect Suboxone Film from generic competition. The litigation has involved patents covering film formulations, dosage forms, and related delivery technology. Courts and the U.S. Patent Trial and Appeal Board have addressed validity, infringement, and the timing of generic entry.

The most important business effect of this litigation was delay or management of generic film competition. Once generic film products entered, price compression increased and branded market share became harder to defend.

What Paragraph IV risks exist?

Paragraph IV challenges create four principal risks:

1. Generic entry before the asserted patent expiry date.
2. Loss of exclusivity if a court finds the patent invalid or not infringed.
3. Earlier-than-expected settlement entry.
4. Price erosion from authorized or semi-branded generic strategies.

For Cassipa, a Paragraph IV challenge would have limited incremental value if generic products already have broad substitution rights in the same active-ingredient category. The commercial risk remains meaningful where a challenger targets the film formulation, a specific strength, or a payer segment with high brand retention.

What formulations are protected by Cassipa-related patents?

The relevant technology includes polymeric sublingual films that deliver buprenorphine and naloxone, control dose uniformity, dissolve in the oral cavity, and limit abuse or diversion.

Potentially relevant claim categories include:

• Film composition.
• Drug loading and dose uniformity.
• Polymer and solvent systems.
• Sublingual dissolution characteristics.
• Buprenorphine-to-naloxone ratios.
• Manufacturing processes.
• Packaging and handling.
• Methods of treating opioid dependence.

Formulation patents can extend commercial protection beyond the basic active ingredients. They are also vulnerable to non-infringing alternative formulations, claim-construction disputes, enablement challenges, and obviousness arguments.

How strong is the Cassipa patent estate?

Cassipa’s patent estate is commercially useful but not equivalent to the estate supporting a novel molecular entity. Its strengths are the complexity of film manufacture, the accumulated litigation record around buprenorphine/naloxone films, and the operational difficulty of matching product quality at scale.

Its weaknesses are generic familiarity with the active ingredients, the availability of alternative tablet and film formulations, the absence of NCE exclusivity, and the mature nature of the market.

Patent-strength factor	Assessment
Active-ingredient differentiation	Weak
Formulation complexity	Moderate
Manufacturing barrier	Moderate
Regulatory exclusivity	Limited
Generic substitution risk	High
Litigation leverage	Moderate, product-specific
Long-term franchise durability	Low for Cassipa alone

What is Cassipa’s financial trajectory?

Indivior does not report Cassipa as a separate revenue segment in its annual reports. Public financial disclosures generally group products within broader categories, including Suboxone, Sublocade, Perseris, and other addiction-treatment products.[4]

Cassipa’s revenue trajectory is therefore expected to follow five market forces:

1. Generic price erosion.
2. Declining branded film utilization.
3. Payer preference for lower-cost products.
4. Migration to long-acting injectable buprenorphine.
5. Indivior’s strategic shift toward Sublocade and newer addiction-treatment products.

Revenue exposure

Cassipa’s direct revenue exposure is likely modest relative to Indivior’s total sales. The larger financial exposure is indirect: Cassipa, Suboxone Film, and generic products compete within the same buprenorphine/naloxone treatment pool.

Indivior’s strategic priority has shifted toward Sublocade, which has stronger product differentiation, monthly or longer dosing intervals, and greater protection from immediate oral generic substitution. Brixadi increases pressure in the injectable segment but also validates the market’s movement toward long-acting treatment.

Financial trajectory by period

Period	Expected Cassipa market direction
2018-2019	Early launch and limited brand adoption
2020-2022	Increased generic competition and payer pressure
2023-2024	Mature, price-sensitive film market; injectable competition expands
2025 onward	Continued erosion unless supported by contracting, supply advantages, or niche formulary access

Cassipa is unlikely to become a major standalone growth driver. Its value is tied to retaining selected prescriptions, supporting Indivior’s film portfolio, and maintaining presence in opioid-use-disorder treatment while the company expands injectable products.

What generic launch scenarios exist for Cassipa?

Scenario 1: Broad generic substitution

Generic films and tablets gain preferred formulary status. Cassipa volume declines, while net price falls. This is the most probable long-term scenario for a mature oral film product.

Scenario 2: Managed brand retention

Indivior uses rebates, contracting, patient support, and supply reliability to preserve a defined share. Revenue declines more slowly, but gross-to-net deductions increase.

Scenario 3: Formulation-specific protection

A Cassipa-specific formulation or manufacturing patent limits direct film substitution for a period. The benefit would depend on whether physicians and payers view the product as clinically distinct.

Scenario 4: Injectable migration

Patients move from daily sublingual films to Sublocade or Brixadi. Cassipa loses volume, but Indivior may retain some patients through its injectable portfolio.

What manufacturing and intellectual-property barriers affect Cassipa?

Manufacturing is a meaningful but temporary barrier. Sublingual films require consistent drug distribution, adhesion, dissolution, moisture control, packaging, and dose uniformity. These requirements can create development and inspection risks for generic manufacturers.

The barrier is weaker than the barrier for sterile injectables. Once a generic manufacturer completes bioequivalence, chemistry, manufacturing, and controls requirements, oral-film competition can scale quickly.

Geographically, Cassipa’s principal commercial and patent exposure is the United States. FDA approval, Orange Book listings, U.S. Medicaid reimbursement, and U.S. ANDA litigation are more important than international markets because Cassipa’s commercial identity is tied to Indivior’s U.S. opioid-use-disorder franchise.

What is the competitive outlook for Cassipa?

Cassipa operates in a structurally mature market with continuing clinical demand. Opioid-use disorder remains a large treatment need, but market growth does not guarantee branded film growth. Volume expansion can be captured by generics, long-acting injections, or competing treatment modalities.

The strongest growth asset in Indivior’s portfolio is Sublocade rather than Cassipa. The main risks to Cassipa are generic substitution, payer exclusion, low brand differentiation, and patient migration to injectable buprenorphine.

Key Takeaways

• Cassipa is a buprenorphine/naloxone sublingual film approved by the FDA in 2018.
• It is a small-molecule product, so biosimilar competition is irrelevant.
• Its commercial protection depends on formulation, manufacturing, method-of-use, and related film patents rather than NCE exclusivity.
• Generic buprenorphine/naloxone products create high substitution and pricing risk.
• Indivior does not separately disclose Cassipa revenue, preventing a standalone revenue-growth calculation from public filings.
• Cassipa is a mature, secondary product within Indivior’s addiction-treatment portfolio.
• Sublocade and Brixadi increase the risk of migration away from daily sublingual films.
• The likely long-term trajectory is declining branded film revenue, with limited upside from niche payer access or portfolio contracting.

FAQs

Is Cassipa the same as Suboxone?

Cassipa and Suboxone both contain buprenorphine and naloxone and are delivered as sublingual films. They are separate branded products with separate regulatory applications and commercial histories.

Can a generic replace Cassipa?

A generic buprenorphine/naloxone product may be substituted depending on dosage strength, state pharmacy law, payer policy, and the prescriber’s instructions. Tablet and film products are not always interchangeable in every commercial setting.

Does Cassipa have biosimilar risk?

No. Cassipa is a small-molecule combination drug. Its competitive risk comes from generic ANDA products, not biosimilars.

Is Cassipa covered by Medicaid?

Coverage varies by state Medicaid program and managed-care plan. Formulary placement depends on negotiated rebates, preferred-drug-list decisions, clinical criteria, and availability of lower-cost generic alternatives.

Is Cassipa a growth product for Indivior?

Cassipa is unlikely to be a major growth driver. Indivior’s growth strategy has focused more heavily on long-acting injectable buprenorphine, particularly Sublocade, while oral film products face generic and payer pressure.

References

1. U.S. Food and Drug Administration. (2018). FDA approves Cassipa buprenorphine and naloxone sublingual film prescribing information.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book.
3. U.S. Court of Appeals for the Federal Circuit. (2020). Indivior Inc. v. Dr. Reddy’s Laboratories, S.A., 930 F.3d 1325.
4. Indivior PLC. (2024). Annual report and accounts 2023.