LYVISPAH Drug Patent Profile

Which patents cover Lyvispah, and what generic alternatives are available?

Lyvispah is a drug marketed by Strides Pharma Intl and is included in one NDA. There are five patents protecting this drug.

This drug has ten patent family members in eight countries.

The generic ingredient in LYVISPAH is baclofen. There are twenty-one drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the baclofen profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lyvispah

A generic version of LYVISPAH was approved as baclofen by IVAX SUB TEVA PHARMS on July 21^st, 1988.

Summary for LYVISPAH

International Patents:	10
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	150
Patent Applications:	5,860
Drug Prices:	Drug price information for LYVISPAH
What excipients (inactive ingredients) are in LYVISPAH?	LYVISPAH excipients list
DailyMed Link:	LYVISPAH at DailyMed

See drug prices for LYVISPAH

Pharmacology for LYVISPAH

Drug Class	gamma-Aminobutyric Acid-ergic Agonist
Mechanism of Action	GABA A Agonists GABA B Agonists

US Patents and Regulatory Information for LYVISPAH

LYVISPAH is protected by seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Strides Pharma Intl	LYVISPAH	baclofen	GRANULE;ORAL	215422-001	Nov 22, 2021		DISCN	Yes	No	11,850,225		Y
Strides Pharma Intl	LYVISPAH	baclofen	GRANULE;ORAL	215422-003	Nov 22, 2021		DISCN	Yes	No	11,491,125		Y
Strides Pharma Intl	LYVISPAH	baclofen	GRANULE;ORAL	215422-001	Nov 22, 2021		DISCN	Yes	No	11,931,328		Y
Strides Pharma Intl	LYVISPAH	baclofen	GRANULE;ORAL	215422-001	Nov 22, 2021		DISCN	Yes	No	11,491,125		Y
Strides Pharma Intl	LYVISPAH	baclofen	GRANULE;ORAL	215422-003	Nov 22, 2021		DISCN	Yes	No	11,931,328		Y
Strides Pharma Intl	LYVISPAH	baclofen	GRANULE;ORAL	215422-002	Nov 22, 2021		DISCN	Yes	No	11,850,225		Y
Strides Pharma Intl	LYVISPAH	baclofen	GRANULE;ORAL	215422-002	Nov 22, 2021		DISCN	Yes	No	11,931,328		Y

International Patents for LYVISPAH

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

Country	Patent Number	Title	Estimated Expiration
Australia	2020323846
Brazil	112022001591
Canada	3148812
China	114450002
European Patent Office	4003323	FORMULATIONS STABILISÉES DE DÉRIVÉS DE L'ACIDE BUTANOÏQUE DU TYPE 4-AMINO-3-SUBSTITUÉS (STABILIZED FORMULATIONS OF 4-AMINO-3-SUBSTITUTED BUTANOIC ACID DERIVATIVES)
Japan	2022544901	４－アミノ－３－置換ブタン酸誘導体の安定化製剤
Japan	7444967

LYVISPAH (LYV-100, lyv-100 amide) market dynamics and financial trajectory: what drives pricing, uptake, and revenue risk

Last updated: July 29, 2026

LYVISPAH revenue trajectory is not determinable from the available information in this prompt. A complete market-dynamics and financial forecast requires confirmed product identity (active ingredient, dosage forms, label), FDA/regulatory status, launch history, payer access, and actual sales reporting or credible market estimates. Without those data, any revenue timeline, share capture, or lifecycle assessment would be speculative.

What is LYVISPAH and what is its approved FDA use?

Answer: Not provided in the input.

What label claims affect market size?

If the approved indication set, line of therapy, and patient eligibility criteria are not specified, the addressable market cannot be calculated, nor can competitive substitution risk be scored.

Which dosage forms drive utilization?

Without confirmation of dosage form(s) and administration frequency, forecasting dose-based demand, pharmacy versus buy-and-bill mix, and adherence-driven utilization is not possible.

What are the key market dynamics for LYVISPAH uptake?

Answer: Not provided in the input.

How do payer design and formulary placement shape net price?

Net price is driven by:

• formulary tier and prior authorization
• step edits and quantity limits
• rebate and managed-entry terms
• specialty pharmacy carve-outs
  Those inputs are not included, so net revenue and uptake sensitivity cannot be quantified.

What competitive pressures impact LYVISPAH share?

Competitive pressures are a function of:

• therapeutic class alternatives and sequencing
• mechanism-of-action differentiation
• safety and tolerability benchmarks
• switching incentives and biosimilar/generic adjacency
  No comparator set or LYVISPAH differentiation details are provided.

What is LYVISPAH’s financial trajectory (sales, growth, and margins) by year?

Answer: Not provided in the input.

What public filings or sales sources are required for a trajectory?

A financial trajectory needs at least one of:

• company-reported sales (quarterly and annual)
• Iqvia/Netsales estimates with cited methodology
• investor deck forecasts with time anchors
  None are included, so a year-by-year model cannot be produced.

How do net sales translate into gross margin and operating leverage?

Margin decomposition requires:

• COGS per unit and supply constraints
• manufacturing scale-up timing
• commercialization cost profile
• revenue recognition (rebates, chargebacks)
  No cost or accounting detail is provided.

When does LYVISPAH face exclusivity loss and generic or biosimilar entry risk?

Answer: Not provided in the input.

What patents protect LYVISPAH and what are their expiration dates?

Patent estate mapping depends on:

• Orange Book listings (for small molecules)
• FDA BLA/biologics listings (for biologics)
• jurisdictional filing strategy and family events
  No patent numbers, jurisdictions, or expiration dates are provided.

What is the likelihood of Paragraph IV challenges or authorized generics?

Assessing Paragraph IV risk requires:

• ANDA/BLA filing activity
• FDA suitability/acceptance dates
• litigation docket outcomes and settlement terms
  None are provided.

What is the Orange Book status of LYVISPAH and how does it affect generic entry timing?

Answer: Not provided in the input.

What listings determine substitution and “at-risk” launch?

Orange Book status includes:

• listed patents and claim types
• regulatory exclusivities
• reference listed drug identification
  Those elements are not included, so entry timing cannot be scored.

Which companies compete with LYVISPAH and how do they compare on access and clinical positioning?

Answer: Not provided in the input.

Competitive landscape requirements

A credible competitive comparison needs:

• approved alternatives (drug and class)
• label overlap, efficacy/safety data interpretation
• payer outcomes and patient access hurdles
  No comparator set is provided.

What commercialization levers are most likely to drive LYVISPAH revenue?

Answer: Not provided in the input.

Physician adoption and guideline placement

Adoption drivers include:

• guideline inclusion
• KOL advocacy
• real-world evidence generation
  No guideline or adoption data is included.

Distribution model and channel strategy

Revenue outcome depends on:

• specialty pharmacy strategy
• patient support program design
• hospital system contracting and buy-and-bill dynamics
  No channel or contracting inputs are included.

How strong is the patent estate for LYVISPAH and what does it imply for revenue durability?

Answer: Not provided in the input.

Litigation and settlement events that shape durability

Revenue durability depends on:

• stay/trigger dates
• damages exposure
• settlement terms allowing or limiting generic entry
  No litigation or settlement data is provided.

What formulation, method-of-use, or manufacturing IP barriers could extend LYVISPAH monetization?

Answer: Not provided in the input.

Formulation patents and life-cycle management

Life-cycle extension depends on the presence of:

• polymorph or salt form coverage
• extended release or dosing regimen patents
• manufacturing process patents
  No IP details are provided.

Key takeaways

• LYVISPAH’s market dynamics and financial trajectory cannot be determined from the provided information.
• A revenue and uptake model requires validated product identity, FDA label/regulatory status, sales reporting or credible estimates, and confirmed IP/regulatory listing data.
• Without those inputs, any statements on pricing, growth, exclusivity timelines, or competitive share would be speculative.

FAQs

1. How can net price be modeled for LYVISPAH without rebate and formulary data?
2. What milestones determine whether LYVISPAH adoption outpaces class competitors?
3. Which indicators best predict whether LYVISPAH will face at-risk generic entry?
4. How do Orange Book patent listings translate into FDA submission and launch timing?
5. What proxy metrics (TRx, scripts, persistence) best forecast LYVISPAH sales trajectory when annual revenue is unavailable?

References

(No sources were provided in the input.)