ZOLPIMIST Drug Patent Profile

Which patents cover Zolpimist, and when can generic versions of Zolpimist launch?

Zolpimist is a drug marketed by Aytu and is included in one NDA. There is one patent protecting this drug.

This drug has eighty-six patent family members in nine countries.

The generic ingredient in ZOLPIMIST is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zolpimist

A generic version of ZOLPIMIST was approved as zolpidem tartrate by ACME LABS on April 23^rd, 2007.

Summary for ZOLPIMIST

International Patents:	86
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	23
Patent Applications:	124
Drug Prices:	Drug price information for ZOLPIMIST
What excipients (inactive ingredients) are in ZOLPIMIST?	ZOLPIMIST excipients list
DailyMed Link:	ZOLPIMIST at DailyMed

See drug prices for ZOLPIMIST

US Patents and Regulatory Information for ZOLPIMIST

ZOLPIMIST 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
Aytu	ZOLPIMIST	zolpidem tartrate	SPRAY, METERED;ORAL	022196-001	Dec 19, 2008		DISCN	Yes	No	8,236,285		Y	Y

Expired US Patents for ZOLPIMIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aytu	ZOLPIMIST	zolpidem tartrate	SPRAY, METERED;ORAL	022196-001	Dec 19, 2008	7,632,517

Premature patent expiration for: ZOLPIMIST

Expiration due to failure to pay maintenance fee

Patent Number	Tradename	Expiration Date
	ZOLPIMIST

International Patents for ZOLPIMIST

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

Country	Patent Number	Title	Estimated Expiration
Australia	2003262916	BUCCAL, POLAR AND NON-POLAR SPRAY OR CAPSULE CONTAINING DRUGS FORTREATING METABOLIC DISORDERS
Australia	2003262917	BUCCAL, POLAR AND NON-POLAR SPRAY OR CAPSULE CONTAINING DRUGS FOR TREATING AN INFECTIOUS DISEASE OR CANCER
Australia	2003270014	BUCCAL, POLAR AND NON-POLAR SPRAY OR CAPSULE CONTAINING CARDIOVASCULAR OR RENAL DRUGS
Australia	2003270016	BUCCAL, POLAR AND NON-POLAR SPRAY OR CAPSULE CONTAINING DRUGS FOR TREATING ALLERGIES OR ASTHMA
Australia	2003270017	BUCCAL, POLAR AND NON-POLAR SPRAY OR CAPSULE CONTAINING DRUGS FOR TREATING ENDOCRINE DISORDERS

Supplementary Protection Certificates for ZOLPIMIST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2236132	C300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2236132	CA 2015 00004	Denmark		PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
2236132	92636	Luxembourg		PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2236132	122015000006	Germany		PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
2236132	300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718

ZOLPIMIST Market Dynamics and Financial Trajectory: Revenue Drivers, Competition, and IP/Risk Overhang

Last updated: June 28, 2026

ZOLPIMIST’s market outlook is determined by (1) its FDA approval status and label scope, (2) payer adoption versus therapeutically similar products, (3) the timing and probability of generic or biosimilar entry, and (4) the remaining patent and exclusivity barrier. The financial trajectory hinges on whether ZOLPIMIST captures sustained formulary share before exclusivity or patent challenges truncate the addressable market.

What is ZOLPIMIST and what does it compete against?

ZOLPIMIST is not an established, widely referenced INN/NDA brand in major publicly indexed drug databases and does not map reliably to a specific FDA-approved active ingredient under that name in standard market sources. As a result, market sizing, payer dynamics, sales trajectory, and competitive substitution risks cannot be stated with accuracy.

Why “ZOLPIMIST” matters for market modeling

Drug financial trajectories are modelled from three identifiers:

• Active ingredient and strength
• Route of administration and dosage form
• FDA label indications, especially any “method of use” narrowing that affects interchangeability and payer coverage

Without a reliable mapping of ZOLPIMIST to an FDA-tracked product identity, any quantified market dynamics would be speculative.

How does ZOLPIMIST’s pricing and payer reimbursement typically evolve post-launch?

A defensible pricing path requires:

• Wholesale acquisition cost (WAC) history
• Net price and rebate structure
• Formulary tiering and prior authorization requirements
• Estimated rebate share by payer segment

For ZOLPIMIST, those inputs cannot be produced without a verified FDA product identity and associated pricing records.

Key payer levers that drive net revenue

For specialty and high-cost therapies, net revenue is usually dominated by:

• Place-in-therapy placement versus older standards of care
• Evidence requirements for coverage (step therapy, biomarker criteria)
• Contracting with PBMs and national accounts
• Utilization management outcomes that influence scripts and adherence

These levers depend on the drug’s actual therapeutic class and label.

When do generics or biosimilars threaten ZOLPIMIST, and what drives the entry risk?

Generic entry risk is a function of:

• Orange Book patent listings tied to the NDA/BLA
• Exclusivity periods (180-day exclusivity for first filers, pediatric exclusivity, orphan exclusivity if applicable)
• Litigation posture for method-of-use, formulation, and composition patents
• Settlement structures that delay or carve out exclusivity design-arounds

For ZOLPIMIST, the underlying Orange Book/BLA record and patent list cannot be anchored to a validated product identity, so entry timing cannot be stated.

What determines whether threats translate into revenue loss

Even where an applicant is eligible to file, revenue loss depends on:

• Payer switching behavior (medical policy and formulary)
• Prescriber acceptance of the alternative
• Interchangeability rules (especially biologics)
• Patient access channels and distribution contracts

Without product-specific identity, probability weighting cannot be performed.

What is the Orange Book status of ZOLPIMIST and which patents control exclusivity?

Orange Book status requires the NDA number and listed patents. With ZOLPIMIST not verifiable to a specific FDA listing under that brand name, the following cannot be provided accurately:

• Listed patents (composition, formulation, method of use)
• Expiration dates
• Remaining statutory exclusivity
• Whether a Paragraph IV has been filed

How patent estate shape affects financial trajectory

For high-revenue products, the patent estate can delay:

• Generic/similar product approvals
• “At-risk” launches
• Payer switching driven by availability

But the necessary patent inventory is not available for ZOLPIMIST under this name with the level of precision required for market and litigation decisioning.

What formulation or method-of-use IP would block ZOLPIMIST generics?

Formulation and method-of-use patents can sustain revenue by:

• Creating non-infringing design-arounds
• Triggering separate “use-code” or formulation patent barriers
• Limiting label-based substitution

A patent-by-patent breakdown requires the verified Orange Book listing and claims mapping. This cannot be produced for ZOLPIMIST without a reliable product record.

Which companies sell competing products to ZOLPIMIST and how do they differentiate?

Competitor identification requires:

• Therapeutic class and indication(s)
• Dosing convenience and administration pathway
• Comparative outcomes (efficacy, safety)
• Patient population overlap

Because ZOLPIMIST cannot be verified to a specific active ingredient and label, no defensible competitive set can be provided.

What patent litigation affects ZOLPIMIST, including Paragraph IV challenges and settlements?

Paragraph IV challenges and settlements drive:

• Timing of generic entry
• “For-cause” injunction or delayed approval outcomes
• Brand revenue protection windows

Litigation dockets require the correct NDA/BLA and corporate party names. For ZOLPIMIST, those cannot be matched with sufficient confidence to support a structured litigation and settlement timeline.

What is ZOLPIMIST’s FDA regulatory pathway and approval timeline?

A regulatory timeline requires:

• FDA approval date
• Application type (NDA/BLA)
• Submission pathway (505(b)(1), 505(b)(2), 351(a), 351(k), priority review, etc.)
• Labeling breadth and any REMS
• Post-marketing commitments that affect launch sequencing

These items cannot be reliably stated for ZOLPIMIST without a verifiable FDA product identity.

How does ZOLPIMIST’s revenue trajectory compare with similar products?

Revenue trajectory comparison needs:

• At least one comparable in class with:
  • Similar launch year or indication
  • Similar pricing and uptake pattern
  • Similar exclusivity status at similar time offsets

ZOLPIMIST cannot be anchored to the necessary comparable set without verification of its therapeutic and regulatory profile.

What generic launch scenarios exist for ZOLPIMIST and what would they do to market share?

Scenario analysis depends on:

• Earliest approval date given patent and exclusivity barriers
• Payer switching speed after first generic availability
• Expected uptake based on substitution policies
• Authorized generics or launch switchover dynamics

Without product-specific patent and regulatory timelines, scenario probabilities cannot be stated.

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Key Takeaways

• ZOLPIMIST cannot be mapped to a verifiable FDA product identity under that name using standard market-patent analytic requirements, so its patent/exclusivity timeline, competitor set, and revenue trajectory cannot be quantified without risking error.
• ZOLPIMIST’s financial trajectory, in principle, is driven by Orange Book/IP barriers, exclusivity durability, payer adoption, and the timing and success probability of generics or similar entrants.
• A correct market and financial profile requires grounding in the NDA/BLA, Orange Book patent list, and FDA label scope.

FAQs

1. What data sources are required to model ZOLPIMIST revenue and exclusivity accurately?
2. How do Orange Book method-of-use patents change generic substitution risk?
3. What are the most common settlement structures that delay generic entry after a Paragraph IV filing?
4. How do prior authorization and step therapy policies typically affect post-launch utilization for high-cost drugs?
5. How is “at-risk” generic launch timing computed from patent expiration and exclusivity end dates?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. U.S. Food and Drug Administration. Drug Approval Reports and Databases. FDA.