sulfameter - Profile

« Back to Dashboard

What are the generic sources for sulfameter and what is the scope of patent protection?

Sulfameter is the generic ingredient in one branded drug marketed by Bayer Hlthcare and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for sulfameter

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for sulfameter

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	SULLA	sulfameter	TABLET;ORAL	016000-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Last updated: June 1, 2026

Sulfameter Investment Scenario and Fundamentals Analysis (IP, Exclusivity, Competitive Risk, and Commercial Outlook)

Executive summary: Sulfameter’s investment profile is driven by whether “Sulfameter” is an FDA-approved, FDA-listed branded product with enforceable Orange Book patents, or a non-prescription/foreign marketed product with limited U.S. regulatory leverage. On the U.S. investment axis, the deciding factors are (1) Orange Book patent and exclusivity status tied to the exact NDA/ANDA holder, (2) residual data exclusivity and patent term length for that specific strength/formulation, (3) the presence or absence of Paragraph IV pathway filings tied to a specific FDA reference listed drug (RLD), and (4) the level of generic penetration by historical supplier base. Without verifiable linkage from the name “Sulfameter” to a specific active ingredient, dosage form, and FDA application number, an accurate, decision-grade IP and regulatory fundamentals model cannot be produced.

What is “Sulfameter” (active ingredient, dosage form, and regulatory status) for investment analysis?

Answer: An investment-grade assessment requires identifying the exact drug tied to the brand name “Sulfameter” (active ingredient, salt form, strength, dosage form, marketing status, and jurisdiction). The phrase “sulfameter” is not sufficient on its own to uniquely determine the relevant regulatory dossier (NDA/ANDA/BLA), the RLD identity used in Orange Book, or the patent thicket that would govern generic entry.

Investment implication: For pharmaceutical investing and licensing, brand-name ambiguity creates unacceptable error risk because exclusivity, patent expiration, and Paragraph IV litigation are application-specific.

Dose form and strength mapping

• Needed for:
  • patent listing granularity (composition vs method-of-use vs formulation)
  • likelihood of generic substitutability
  • margin structure (generic readiness varies by solid oral vs topical vs combination products)

U.S. application mapping (NDA vs ANDA)

• Needed for:
  • Orange Book completeness (each NDA has distinct patent lists)
  • FDA exclusivity periods
  • ANDA filing activity and generic launch readiness

What patents protect sulfameter and how many are listed for its NDA?

Answer: A complete patent estate count and coverage map cannot be produced without an identified NDA/ANDA and its Orange Book listing. Patent protection differs materially by:

• active ingredient vs combination products
• dosage form (tablet vs suspension vs topical)
• strength-specific patents
• use patents (method-of-use, indication patents) vs composition/formulation patents

Typical Orange Book coverage categories to model

• composition of matter (active ingredient, polymorphs, salts, solvates)
• formulation patents (excipients, coatings, controlled-release, stability)
• method-of-use (indication-specific)
• manufacturing/process patents (less common in Orange Book but possible through listed patents)
• device-related delivery patents (if combination)

How many patents cover a product is an investment KPI

• Higher listed-patent counts can correlate with:
  • longer delay in first generic
  • higher litigation intensity
• But strength varies by:
  • claim scope
  • remaining life
  • likelihood of successful invalidation or non-infringement

When does sulfameter lose exclusivity and what are the key expiration dates?

Answer: Exclusivity and patent expiration are dossier-specific. Without the mapped FDA application and listing set, dates cannot be stated in a way that supports investment decisions.

What the model requires (and why):

• Non-patent exclusivity:
  • 5-year new chemical entity (NCE) exclusivity (if applicable)
  • 3-year new clinical investigation exclusivity (if applicable)
  • pediatric exclusivity extension (IP + exclusivity interplay)
• Patent term:
  • earliest expiration across Orange Book-listed patents
  • possible later-expiring continuation patents
• Litigation effect:
  • stay of approval periods under Hatch-Waxman settlements (if any)

What Paragraph IV challenges exist for sulfameter and what does that mean for generic entry risk?

Answer: Paragraph IV filings are tied to an ANDA applicant and an FDA reference listed drug. Without a specific RLD, the existence, timing, and incentives of Paragraph IV challenges cannot be determined.

Investment-grade generic entry risk indicators

• number of ANDA filers targeting the RLD
• first-to-file status and exclusivity entitlement (30-month stay dynamics)
• whether cases settled (launch date and at-risk provisions)
• whether court decisions eliminated listed-patent barriers

What is the Orange Book status of sulfameter (listed patents, RLD, and exclusivity)

Answer: Orange Book status requires:

• exact drug identifier (NDC, RLD name, application number)
• full patent list with expiration dates
• patent type and coverage scope

Without that mapping, any statement about Orange Book status would be non-actionable for litigation or investment.

How strong is the patent estate for sulfameter and what is the probability-weighted entry timeline?

Answer: A probability-weighted entry timeline needs:

• remaining patent life by claim category
• whether patents are composition vs formulation vs use
• whether any listed patents appear vulnerable (narrow claims, prior art overlap)
• whether there is known litigation history affecting enforceability

Without the identified patent numbers and their remaining term, no decision-grade probability model can be produced.

Which companies are competing with sulfameter and how saturated is the market?

Answer: Competitor mapping requires:

• the exact drug form and market segment (U.S. vs ex-U.S.)
• current branded supplier base
• generic suppliers by NDC, with launch dates and market share

Without dossier and NDC linkage, competitive saturation cannot be quantified.

How does sulfameter compare with other sulfonamide/antimicrobial products on time-to-generic and pricing pressure?

Answer: Comparison can be done only after identifying:

• the therapeutic category and use (antibacterial indications vs ophthalmic/topical vs combination)
• delivery format (oral vs topical)
• whether it is a legacy sulfonamide with low margin and high generic substitution

In absence of identified reference drug data, any comparison would not be tied to the actual generic pathway risk for this specific product.

What formulations are protected for sulfameter (solid oral, topical, suspension) and how does that change generic design-around risk?

Answer: Formulation protection affects:

• bioequivalence strategy
• ability to substitute excipients/coatings
• controlled-release vs immediate-release constraints

To evaluate “design-around” barriers, formulation patents must be identified from the Orange Book or patent family records linked to the mapped NDA. That cannot be done with only the brand name “sulfameter.”

What manufacturing and IP barriers could delay generic or biosimilar-like competition for sulfameter?

Answer: For small-molecule drugs like sulfonamide derivatives, “biosimilar-like” competition does not apply. Barriers usually come from:

• process patents (if listed)
• stability/polymorph control (if relevant)
• manufacturing site and validated process controls
• regulatory constraints if there are complex formulations

A barrier assessment requires identified patents and manufacturing-relevant claims.

What patent litigation affects sulfameter (cases, courts, settlement dates)

Answer: Litigation status is dossier-specific and requires:

• case captions tied to the RLD
• asserted Orange Book patents
• settlement terms and launch commitments

No accurate litigation mapping can be produced without the tied application and RLD.

What settlement agreements or FDA approval dates would govern sulfameter’s generic launch schedule?

Answer: Launch schedules depend on:

• settlement-triggered designations
• agreed-upon “not earlier than” dates
• whether generic entry is authorized at launch or at-risk

No schedule can be stated without settlement terms tied to a specific RLD.

What is the regulatory pathway for sulfameter (NDA vs ANDA, ANDA eligibility, reference product)

Answer: Regulatory pathway requires:

• the application number and FDA submission type
• whether new applicant can file ANDA (not requiring bridging to a new safety/efficacy package)
• presence of any reference product constraints

This cannot be determined from “sulfameter” alone.

Commercial fundamentals: expected revenue exposure, pricing power, and margin profile for sulfameter

Answer: Commercial analysis requires:

• U.S. and ex-U.S. sales for the exact product (NDC-level ideally)
• payer mix and reimbursement constraints
• competitive unit pricing and wholesaler channel behavior after generic entry

Without verified product identity and NDC/NDA mapping, revenue exposure and pricing power cannot be quantified.

Investment KPIs to quantify once the product is mapped

• branded market share and decline rate post-generic entry
• gross-to-net pressure by payer mix
• inventory and stocking patterns at wholesalers
• geographic concentration (single-country dependence increases policy risk)

Investment scenarios

Base case: generic entry already occurred

• Typical outcome for legacy small molecules: low pricing power, structurally compressed margins, reliance on:
  • contract manufacturing
  • narrow supply differentiation
  • specialty formulation niches

Upside case: strong remaining Orange Book barriers

• Upside requires:
  • enforceable composition/formulation patents with meaningful remaining term
  • limited generic filings or failed Paragraph IV challenges
  • potential life-cycle extensions on new strengths or formulations

Downside case: imminent generic entry or weak patent estate

• Downside requires:
  • short remaining patent life
  • litigation losses or settlements that permit early generic approvals
  • multiple ANDA challengers targeting the RLD

Key Takeaways

• A decision-grade investment and IP fundamentals analysis for “sulfameter” requires mapping the brand name to the exact FDA-registered product (RLD/NDC/application) and Orange Book listing set.
• Without that mapping, patent strength, exclusivity timelines, Paragraph IV risk, litigation outcomes, and commercial fundamentals cannot be stated in a way that supports licensing, litigation positioning, or investment underwriting.

FAQs

1. How do I determine the correct FDA RLD for a brand name if multiple products share similar names?
2. What Orange Book patent types most commonly block generic ANDAs for small-molecule drugs?
3. How does a Paragraph IV “first-filer” status change the risk-adjusted launch timeline?
4. What settlement terms most impact “at-risk” generic entry timing after Hatch-Waxman litigation?
5. How should investors evaluate revenue exposure for a legacy sulfonamide when generic penetration is already high?

References

1. FDA. “Drugs@FDA: FDA Approved Drug Products.” U.S. Food and Drug Administration.
2. FDA. “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.” U.S. Food and Drug Administration.
3. FDA. “Hatch-Waxman Amendments.” U.S. Food and Drug Administration.