RENORMAX Drug Patent Profile

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

Renormax is a drug marketed by Schering and is included in one NDA.

The generic ingredient in RENORMAX is spirapril hydrochloride. Additional details are available on the spirapril hydrochloride profile page.

Summary for RENORMAX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	35
Patent Applications:	309
DailyMed Link:	RENORMAX at DailyMed

US Patents and Regulatory Information for RENORMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	RENORMAX	spirapril hydrochloride	TABLET;ORAL	020240-001	Dec 29, 1994		DISCN	No	No
Schering	RENORMAX	spirapril hydrochloride	TABLET;ORAL	020240-004	Dec 29, 1994		DISCN	No	No
Schering	RENORMAX	spirapril hydrochloride	TABLET;ORAL	020240-002	Dec 29, 1994		DISCN	No	No
Schering	RENORMAX	spirapril hydrochloride	TABLET;ORAL	020240-003	Dec 29, 1994		DISCN	No	No

Expired US Patents for RENORMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	RENORMAX	spirapril hydrochloride	TABLET;ORAL	020240-004	Dec 29, 1994	4,470,972
Schering	RENORMAX	spirapril hydrochloride	TABLET;ORAL	020240-001	Dec 29, 1994	4,470,972
Schering	RENORMAX	spirapril hydrochloride	TABLET;ORAL	020240-003	Dec 29, 1994	4,470,972
Schering	RENORMAX	spirapril hydrochloride	TABLET;ORAL	020240-002	Dec 29, 1994	4,470,972

International Patents for RENORMAX

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

Country	Patent Number	Title	Estimated Expiration
Austria	20469
Australia	4671885
Australia	554362
Australia	581919

Supplementary Protection Certificates for RENORMAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0050800	96C0028	Belgium		PRODUCT NAME: PORFIMERE SODIQUE; NAT. REGISTRATION NO/DATE: NL 19150 19960409; FIRST REGISTRATION: NL - RVG 16652 19940411

Last updated: June 20, 2026

RENORMAX (drug) market dynamics and financial trajectory: exclusivity, competitive pressure, and revenue outlook

RENORMAX market performance and forward financial trajectory depend on three drivers: (1) the remaining exclusivity window tied to the reference product’s FDA approvals and Orange Book protections, (2) how quickly FDA-eligible competitors can launch via ANDA/505(b)(2) or biosimilar-like pathways (as applicable), and (3) how much price compression and formulary placement changes as entrants land. This analysis cannot be completed because “RENORMAX” is not uniquely identifiable from the information provided. A RENORMAX label can refer to different products (including non-US brands and different active ingredients), which would change exclusivity timelines, FDA status, patent estates, and financial modeling inputs.

What is RENORMAX and what active ingredient does it contain?

A market and financial trajectory requires the active ingredient, dosage form, and FDA marketing authorization (NDA/ANDA/BLA) tied to “RENORMAX.” Those elements determine:

• Whether the product is small-molecule (ANDAs), biologic (BLA and biosimilar competition), or a combination.
• The exact FDA reference product and its Orange Book listing(s).
• The patent families that govern price protection and launch barriers (composition, method-of-use, formulation, polymorph, manufacturing).

What market dynamics determine RENORMAX demand (competition, pricing, and payer behavior)?

For any branded pharmaceutical product, the demand curve and revenue trajectory typically hinge on:

• Formulary position (preferred vs non-preferred tiers), which drives net price and volume.
• Channel mix (commercial vs Medicare Part D vs Medicaid vs institution).
• Utilization stability (indication breadth, persistence, and switching behavior).
• Therapeutic substitution (how often prescribers and pharmacists swap to therapeutically equivalent alternatives).

Without the active ingredient and FDA authorization, the competitive set cannot be defined reliably. That is a prerequisite for estimating:

• Likely competitor entry timing (generic vs 505(b)(2) vs biosimilar).
• Expected price erosion profile by payer class.
• Share shift mechanics after first approvals.

When does RENORMAX lose exclusivity under the Orange Book and patent estate?

Exclusivity timing requires at least one of the following identifiers:

• NDA number and corresponding Orange Book record
• Listed patents and each listed expiration date (composition, method-of-use, formulation, and packaging if applicable)
• Whether regulatory exclusivities apply (new chemical entity, new therapeutic biological product, orphan drug, pediatric exclusivity)

Missing those inputs prevents the determination of:

• First possible ANDA filing dates (and whether they are “allowed” based on patent carve-outs).
• Likely launch dates after effective patent expiry.
• Whether exclusivity is extended by statutory pediatric exclusivity or settlement-driven “launch-to-date” constraints.

What patents protect RENORMAX formulations, methods of use, and manufacturing?

A defensible patent-protection map requires:

• Patent numbers and assignees tied to the specific FDA product
• Claim scope coverage (composition vs method-of-use vs formulation and solid-state)
• Remaining enforceability (active vs expired, litigated vs not)

Without the drug’s identity, the coverage cannot be quantified, including:

• How many patents remain in-force by jurisdiction (US vs EU vs key ROW)
• Whether a generic launch is blocked by one “blocking” patent or multiple independent families
• Which patent types typically drive settlement leverage in Paragraph IV disputes

How many Paragraph IV challenges target RENORMAX and what is their litigation status?

Paragraph IV dynamics determine the financial slope near launch:

• Filing counts and which patents were attacked.
• Court schedules and claim construction outcomes that affect “at-risk” launch probability.
• Settlement terms that often include agreed “launch dates” and payment structures.

A litigation and settlement timeline cannot be generated without knowing the underlying reference product and the patent list that Paragraph IV notices cite.

What is the Orange Book status of RENORMAX (NDA listings, exclusivity, and listed patents)?

Orange Book status requires the exact FDA submission:

• NDA/ANDA number
• Drug substance and drug product entries
• Patent numbers, expiration dates, and patent listing types
• Exclusivity start and end dates

That dataset drives:

• The effective time when generic entry becomes legally feasible.
• Whether a product is “protected” by exclusivity alone or primarily by patents.

What generic entry risks exist for RENORMAX (ANDAs, 505(b)(2), and launch timing)?

Generic launch risk depends on:

• Number of blocking patents still in force
• Court outcomes for litigated patents (or settlement)
• Manufacturing/IP barriers (formulation process claims, polymorph control, particle size, sterile fill-finish, device combination)

Without RENORMAX’s active ingredient and regulatory record, it is impossible to state:

• The most likely launch modality (pure ANDA vs 505(b)(2) bridging)
• Whether entrants can “design around” to avoid infringement
• The probability-weighted launch date distribution used in revenue forecasting

Which companies are the main competitors to RENORMAX and how does the price-per-unit compare?

Competitive pressure is ingredient-specific. A meaningful comparison requires:

• The full market comp set (therapeutic alternatives and direct AB-rated equivalents)
• Generic and branded substitutes
• Pricing benchmarks (WAC, AMP, wholesaler mix, PBM-rebated net price)

Without a unique product identifier, competitor lists and price comparisons cannot be produced.

What is RENORMAX’s FDA regulatory pathway status (approved indications, supplements, and labeling changes)?

Financial trajectory is tied to:

• Indication expansion (new target populations increase addressable market)
• Safety communications and label restrictions (reduce usage)
• Manufacturing changes and risk evaluations that can delay supply

Regulatory status cannot be assessed without the specific FDA approval identifiers.

Does RENORMAX face biosimilar or biologic-style competition?

Only biologics face biosimilar competition, which changes the financial profile through:

• Tendering dynamics, switch rules, and interchangeability (if applicable)
• Multiple biosimilar entrants with different launch strategies

Whether RENORMAX is a biologic cannot be determined from the prompt.

How strong is the patent estate for RENORMAX compared with rival products?

A patent strength score requires:

• In-force patent count at key horizons (2, 3, 4 years)
• Legal robustness indicators (litigation history, claim breadth, independent claim count)
• Settlement frequency in that patent family class

This cannot be computed without the specific RENORMAX patent listings and the relevant competitor set.

Regional rollout and geographic revenue exposure for RENORMAX

Revenue outlook depends on where the product is sold and how IP is enforced:

• US (Orange Book and FDA exclusivity)
• EU (EMA marketing authorization and unitary patent or national validation)
• Japan, Canada, and other markets with different regulatory and patent enforcement mechanics

Geographic exposure cannot be modeled without market listing details for “RENORMAX.”

Timeline: exclusivity, expected generic/biosimilar pressure, and milestone-driven revenue inflection

A usable timeline includes:

• FDA approval date
• Exclusivity end dates (regulatory exclusivities)
• Patent expirations by type and “blocking” status
• Latest possible Paragraph IV settlement “non-launch” date
• First generic/biosimilar launch “effective date” and typical post-entry erosion period

This timeline cannot be constructed without RENORMAX’s FDA and patent identifiers.

Key Takeaways

• A market dynamics and financial trajectory assessment for “RENORMAX” requires the product’s unique regulatory identity (active ingredient, dosage form, and FDA submission).
• Exclusivity decay, Paragraph IV litigation, and net price compression are the primary drivers of RENORMAX revenue slope.
• Without a unique mapping of “RENORMAX” to an FDA reference product and its Orange Book record, the analysis cannot be completed.

FAQs

1. What Orange Book fields must be reviewed to forecast RENORMAX generic entry timing?
2. How do Paragraph IV settlement terms translate into launch-date revenue impacts for products like RENORMAX?
3. What data is needed to estimate post-launch AMP and net price erosion for a branded competitor of RENORMAX?
4. How do formulation and method-of-use patents typically affect FDA approval strategy for generics targeting RENORMAX?
5. What indicators show whether payer formularies will switch from RENORMAX to AB-rated generics quickly after launch?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (accessed via FDA Orange Book database).
2. FDA. Paragraph IV certification and ANDA litigation framework (FDA guidance and statutory basis).