NYMALIZE Drug Patent Profile

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

Nymalize is a drug marketed by Azurity and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in NYMALIZE is nimodipine. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nimodipine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nymalize

A generic version of NYMALIZE was approved as nimodipine by HERITAGE on May 2^nd, 2007.

Summary for NYMALIZE

US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	1
Patent Applications:	4,661
Drug Prices:	Drug price information for NYMALIZE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NYMALIZE
What excipients (inactive ingredients) are in NYMALIZE?	NYMALIZE excipients list
DailyMed Link:	NYMALIZE at DailyMed

See drug prices for NYMALIZE

Recent Clinical Trials for NYMALIZE

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

Sponsor	Phase
Johns Hopkins University	Early Phase 1

See all NYMALIZE clinical trials

Pharmacology for NYMALIZE

Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists

Paragraph IV (Patent) Challenges for NYMALIZE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NYMALIZE	Oral Solution	nimodipine	6 mg/mL	203340	1	2021-11-29

US Patents and Regulatory Information for NYMALIZE

NYMALIZE is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-001	May 10, 2013		DISCN	Yes	No
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-002	Apr 8, 2020	AB	RX	Yes	Yes			Y
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-002	Apr 8, 2020	AB	RX	Yes	Yes			Y
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-002	Apr 8, 2020	AB	RX	Yes	Yes			Y
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-002	Apr 8, 2020	AB	RX	Yes	Yes			Y
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-002	Apr 8, 2020	AB	RX	Yes	Yes

Expired US Patents for NYMALIZE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-002	Apr 8, 2020
Azurity	NYMALIZE	nimodipine	SOLUTION;ORAL	203340-002	Apr 8, 2020

International Patents for NYMALIZE

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

Country	Patent Number	Title	Estimated Expiration
Australia	2003221794	DISPENSER FOR MEDICAMENTS AND METHOD AND APPARATUS FOR MAKING SAME
World Intellectual Property Organization (WIPO)	03093108

Last updated: July 20, 2026

NYMALIZE (Nymalize) market dynamics and financial trajectory

NYMALIZE is a branded pharmaceutical product with limited public, monetizable footprint in the US and ex-US markets based on available market signals. No reliable, source-backed long-term revenue series, segment P&L, or commercial launch/uptake trajectory can be produced to support an investment, licensing, or litigation risk view.

What is NYMALIZE and what does it compete with commercially?

NYMALIZE is marketed as a specific branded pharmaceutical product name, but no source-backed product profile (active ingredient, strength, dosage form, indication set, route, manufacturer/labeler) is available in the provided context to map competitive class dynamics, pricing benchmarks, or payer penetration.

Which therapeutic category and competitors matter for NYMALIZE?

Without label-confirmed active ingredient and indication(s), competitor set construction cannot be done without introducing unverifiable assumptions. Competitive dynamics that drive revenue trajectory depend on:

• drug class and line of therapy
• formulation type (immediate vs extended release, injectable vs oral, etc.)
• efficacy and safety differentiation
• payer tier placement and step edits
• patient access barriers and prior authorization frequency

How does NYMALIZE price, reimbursement, and payer access affect revenue growth?

A financial trajectory for a branded drug is typically explained by three levers:

• net price vs WAC trajectory (rebates, discounts, 340B, managed care)
• formulary placement (preferred vs non-preferred)
• utilization growth and retention (switching, adherence, persistence)

No source-backed data is available here for NYMALIZE’s:

• WAC and NDC-specific pricing moves
• ASP/AWP trends
• payer coverage rates
• restriction intensity (prior auth, quantity limits)
• patient mix (commercial vs Medicare vs Medicaid)

Where does NYMALIZE sit on the adoption curve: launch timing, uptake, and persistence?

A defensible adoption curve requires launch dates (initial and label expansions), early prescribing patterns, and later volume trends by channel (retail, specialty, hospital) or by plan type. None of this information is present in the provided context in a way that can be cited.

What adoption risks could cap NYMALIZE revenue?

Revenue risk typically concentrates in:

• limited eligible population or narrow indication
• competing generics within the class
• payer non-coverage or high burden of coverage requirements
• safety monitoring burdens that slow switching
• contracting and formulary volatility

No product specifics are available here to link NYMALIZE to any of these risk drivers with evidence.

How strong is NYMALIZE’s financial trajectory using market-sized revenue indicators?

A market-sized revenue view needs at least one of:

• FDA prescribing/utilization signals
• Symphony Health or IQVIA-style claims proxies
• company revenue disclosures by product
• wholesaler/dispensing data summaries
• MA-PD plan coverage and utilization coverage

No cited sources are available in the provided context to establish NYMALIZE’s revenue trajectory.

What is NYMALIZE’s revenue sensitivity to channel mix and payer mix?

Financial outcomes for branded therapies are sensitive to:

• retail vs specialty channel exposure
• inpatient vs outpatient billing
• commercial plan mix vs Medicare
• 340B and contract discounts

No NYMALIZE channel mix, pricing, or utilization breakdown is available in the provided context.

Which market dynamics drive NYMALIZE performance: competition, substitution, and pipeline pressure?

Without label and active ingredient confirmation, substitution threats and pipeline pressure cannot be mapped. For a market dynamics analysis, the evidence must include:

• key branded comparators
• generic or biosimilar timelines for the therapeutic class
• guideline updates affecting treatment choice
• major trial readouts that shift standard of care

No such evidence is present here.

What regulatory and labeling factors affect NYMALIZE market uptake?

A regulatory-driven trajectory analysis typically depends on:

• FDA approval pathway and review milestones
• label breadth and any post-marketing restrictions
• REMS requirements (if applicable)
• pediatric exclusivity or exclusivity carve-outs
• real-world safety signals leading to label tightening

No NYMALIZE regulatory facts are available in the provided context to build this section with citations.

What is the Orange Book status of NYMALIZE and how does exclusivity impact revenue?

Orange Book analysis requires at minimum:

• exact active ingredient and dosage form
• listed patents (drug substance, drug product, method)
• listed exclusivity codes (if present)
• patent expiration and carve-outs

No NYMALIZE Orange Book listing details are available in the provided context, so an exclusivity timeline cannot be produced.

What patent or litigation events influence NYMALIZE commercialization and downside risk?

A litigation-driven market trajectory framework needs:

• paragraph IV filings (ANDAs) tied to NYMALIZE’s listed patents
• district court filings and trial schedules
• ITC actions (if any)
• Hatch-Waxman settlements and their agreed generic entry dates
• stay periods and injunction outcomes

No NYMALIZE patent or litigation record is available in the provided context.

How does NYMALIZE compare with other drugs in its class on adoption and financial impact?

A credible peer comparison needs:

• comparable efficacy/safety positioning
• pricing and net cost benchmarks
• plan coverage differences
• utilization and persistence metrics

No NYMALIZE class identity or peer set can be established from the provided context.

Key Takeaways

• NYMALIZE’s market dynamics and financial trajectory cannot be evidenced with source-backed facts based on the information available in the provided context.
• A defensible analysis for revenue trajectory requires label-confirmed product identity (active ingredient, dosage form, indications), FDA regulatory record, Orange Book/exclusivity mapping, and commercial utilization or company financial disclosures.
• Without those cited inputs, any revenue growth/decline path, adoption curve, or competition/substitution assessment would be speculative.

FAQs

1. How can analysts build a revenue trajectory model for a branded drug like NYMALIZE?
2. What data sources best capture branded drug net sales trends and payer access changes?
3. How do Orange Book patent cliffs and exclusivity carve-outs typically change branded net revenue?
4. What competitive events (generic switches, guideline changes, formulary restrictions) most often drive utilization drops?
5. How should commercial teams translate patent and litigation timelines into product budget and forecasting scenarios?

References

No sources were provided in the prompt content, and no cited materials can be produced from the available information.