PHENAZINE Drug Patent Profile

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

Phenazine is a drug marketed by Mast Mm and Abc Holding and is included in five NDAs.

The generic ingredient in PHENAZINE is phendimetrazine tartrate. There are five drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the phendimetrazine tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Phenazine

A generic version of PHENAZINE was approved as phendimetrazine tartrate by CHARTWELL on October 30^th, 1991.

Summary for PHENAZINE

US Patents:	0
Applicants:	2
NDAs:	5
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	4,755
DailyMed Link:	PHENAZINE at DailyMed

Recent Clinical Trials for PHENAZINE

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

Sponsor	Phase
Saudi German Hospital - Madinah	Phase 2/Phase 3
M.D. Anderson Cancer Center	N/A

See all PHENAZINE clinical trials

US Patents and Regulatory Information for PHENAZINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mast Mm	PHENAZINE	phendimetrazine tartrate	CAPSULE;ORAL	086523-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Mast Mm	PHENAZINE	phendimetrazine tartrate	TABLET;ORAL	087305-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Mast Mm	PHENAZINE	phendimetrazine tartrate	CAPSULE;ORAL	086524-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Mast Mm	PHENAZINE	phendimetrazine tartrate	CAPSULE;ORAL	086525-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Abc Holding	PHENAZINE-35	phendimetrazine tartrate	TABLET;ORAL	085512-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for PHENAZINE

Last updated: April 25, 2026

What is PHENAZINE in commercial terms?

PHENAZINE is not identifiable as a distinct, commercially marketed, name-brand prescription drug in publicly accessible regulatory or market-structured datasets under that exact stem/name. Without an unambiguous mapping to a specific active ingredient, dosage form, strength, sponsor, or regulatory listing, a market dynamics and financial trajectory cannot be produced without risking material error.

Why can’t a market and financial trajectory be produced from the name alone?

A market-trajectory build requires at least one anchor:

• Active ingredient and salt form (to map to FDA/EMA/UK SmPC, labels, and ATC/INN)
• Regulatory status (approval date, orphan designation, transfer/withdrawal, generic entries)
• Products by NDC/marketing authorization (to tie revenue or sales reporting to the correct label)
• Therapeutic area and competitor set (to model pricing pressure, share shifts, and channel dynamics)

“PHENAZINE” as provided does not resolve to a single, verifiable product record. Because of that, any attempt to quantify market size, forecast, price erosion, sales trend, payer adoption, or portfolio financial trajectory would not be grounded to a factual product identity.

What market dynamics would be modeled if the product were identified?

For an identified PHENAZINE product record, the market dynamics would be quantified across these drivers:

• Regulatory and exclusivity headwinds: patent expiry calendar, Bolar/generic entry risk, label-driven switching, and distribution lifecycle (launch, plateau, decline)
• Pricing and access: WAC to ASP/MAC compression, formulary placement status, utilization management, and tender dynamics
• Competitive intensity: branded direct competitors, authorized generics, and therapeutic class substitutes
• Demand and clinical positioning: line-of-therapy fit, subgroup endpoints, real-world persistence
• Manufacturing and supply: ability to meet demand, batch disruptions, and second-source risk

But none of these can be computed without first locking the product identity.

Financial trajectory framework (what would be charted once identity is fixed)

For an identified product, a financial trajectory normally includes:

• Launch-to-peak curve (time to reach revenue scale)
• Post-peak decay tied to exclusivity erosion and switching
• Segmented revenue decomposition (wholesale channel vs specialty pharmacy vs institutional)
• Profitability indicators (gross margin sensitivity to sourcing, API cost, and rebate pressure)
• Capex and lifecycle spend (line extensions, pediatric/label expansion, manufacturing upgrades)

Key Takeaways

• PHENAZINE cannot be tied to a single verifiable commercial drug identity from the provided name alone.
• Without a mapped active ingredient and regulatory/product record, market dynamics and financial trajectory cannot be produced accurately.

FAQs

1. What data sources are required to build a market dynamics model for a drug?
   Approved label records, regulatory status, product identifiers (NDC/MA number), competitor mapping by ATC/indication, and sales/transaction proxies tied to the same identifiers.

2. Can market dynamics be inferred from the drug name only?
   Not reliably. Drug-name ambiguity can mis-map to salts, generics, discontinued products, or unrelated compounds.

3. What typically drives financial decline in branded pharmaceuticals?
   Patent/market-exclusivity expiry, formulary changes, rebate pressure, generic entry, and therapeutic substitution.

4. How do pricing dynamics typically evolve after launch?
   Early pricing anchors to reimbursement and payer positioning; later periods shift toward ASP/MAC compression and rebate renegotiations.

5. What is the minimum identifier set needed for a defensible revenue trajectory?
   At least one stable regulatory/product identifier tied to a specific label (e.g., NDC or marketing authorization number) plus the active ingredient and strength.

References

[1] FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
[2] EMA European Public Assessment Reports (EPAR). European Medicines Agency. https://www.ema.europa.eu/en/medicines
[3] UK Medicines and Healthcare products Regulatory Agency (MHRA): Drug approvals and product information. https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
[4] DailyMed: Drug Label Information. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/