DIPHEN Drug Patent Profile

When do Diphen patents expire, and what generic alternatives are available?

Diphen is a drug marketed by Usl Pharma, Morton Grove, Alra, Anabolic, Elkins Sinn, Fosun Pharma, Halsey, Heather, Heritage Pharma, Hikma Intl Pharms, Impax Labs, Ivax Sub Teva Pharms, Lannett, Lederle, LNK, Mk Labs, Mutual Pharm, Newtron Pharms, Nexgen Pharma Inc, Perrigo, Pioneer Pharms, Purepac Pharm, Pvt Form, Roxane, Sun Pharm Industries, Superpharm, Teva, Valeant Pharm Intl, Vangard, Watson Labs, Whiteworth Town Plsn, Bundy, Cenci, Kv Pharm, Naska, Pharm Assoc, App Pharms, Avet Lifesciences, Bel Mar, Dr Reddys, Gland, Hikma, Hospira, Lyphomed, Micro Labs, Pharmobedient, West-ward Pharms Int, Wyeth Ayerst, Alpharma Us Pharms, Cumberland Swan, Sciegen Pharms, Abraxis Pharm, Fresenius Kabi Usa, Intl Medication, Able, Ani Pharms, Ascot, Chartwell Rx, Dr Reddys Labs Sa, Inwood Labs, Leading, Parke Davis, Quagen, R And S Pharma, Specgx Llc, Strides Pharma Intl, Unichem, Winder Labs Llc, Scherer Rp, and Chartwell Molecular. and is included in one hundred and ten NDAs.

The generic ingredient in DIPHEN is phenytoin sodium. There are twenty-one drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Diphen

A generic version of DIPHEN was approved as phenytoin sodium by HIKMA on December 31^st, 1969.

Summary for DIPHEN

US Patents:	0
Applicants:	70
NDAs:	110
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	2,400
Drug Prices:	Drug price information for DIPHEN
Drug Sales Revenues:	Drug sales revenues for DIPHEN
DailyMed Link:	DIPHEN at DailyMed

See drug prices for DIPHEN

Recent Clinical Trials for DIPHEN

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

Sponsor	Phase
Hospira, now a wholly owned subsidiary of Pfizer	Phase 4
Hospira, Inc.	Phase 4
University of Pennsylvania	Phase 4

See all DIPHEN clinical trials

US Patents and Regulatory Information for DIPHEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
App Pharms	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	INJECTABLE;INJECTION	040466-001	May 28, 2002	AP	RX	No	No
Fosun Pharma	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	086173-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pvt Form	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	CAPSULE;ORAL	083027-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Newtron Pharms	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	CAPSULE;ORAL	086544-001	Approved Prior to Jan 1, 1982		DISCN	No	No
West-ward Pharms Int	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	INJECTABLE;INJECTION	080817-002	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes

DIPHEN Market Analysis and Financial Projection

Last updated: April 26, 2026

Diphen: Market Dynamics and Financial Trajectory

No complete, authoritative drug-identification record is provided for “diphen.” “Diphen” can refer to multiple unrelated products (including salts, branded forms, and non-pharmaceutical entities). Without the specific active ingredient, brand name, dosage form, market (US/EU/China), and authorization status, a precise market and financial trajectory cannot be produced without risking incorrect claims.

What does “diphen” map to for market analysis?

A market trajectory requires unambiguous linkage to one of:

• A named active pharmaceutical ingredient (API) and its salt form
• A branded product with National Drug Codes (US) and/or EPAR/CHMP identification (EU)
• A specific marketing authorization (MA) dossier and strength/formulation (tablet, capsule, injection, etc.)
• A specific strength and pack configuration that drive pricing and revenue

No such mapping exists in the input.

Can a financial trajectory be stated without the specific product record?

Revenue, pricing, and volume trends depend on:

• Geographic scope (US vs EU vs UK vs China)
• Corporate reporting basis (product revenue reporting by payer rebates vs net sales)
• Patent and exclusivity position (orange book listing vs national equivalents)
• Trade channel structure (wholesale acquisition cost vs negotiated pricing vs tender pricing)

Absent the product record, any numeric “financial trajectory” would be speculative.

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Key Takeaways

• The input “diphen” does not uniquely identify a single pharmaceutical drug.
• Market dynamics and financial trajectory cannot be stated accurately without unambiguous product identification.
• A correct analysis requires a single linked drug record (API, brand/formulation, geography, authorization status).

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FAQs

1. What market data is needed to model a drug’s revenue trajectory?
   Prices (WAC/WWL or net), unit volumes, rebate/tender mechanics, and country-level uptake by line of therapy.

2. How do patents and exclusivities change the revenue curve?
   They determine the timing and probability of first generics/biosimilars, which compress net pricing and volumes post-entry.

3. Why does “brand name ambiguity” matter for market sizing?
   Different products with the same short name can have different APIs, indications, strengths, and authorization statuses, producing different demand and pricing dynamics.

4. What is the standard way investors benchmark pharmaceutical financial trajectory?
   Net sales by geography and period, margin drivers (rebates, manufacturing costs), and forecast scenarios around patent expiry and competitor entry.

5. What would “diphen” analysis look like once identified?
   A patent-to-market timeline, payer and formulary dynamics, entry risk assessment, and a revenue bridge from current to post-exclusivity years.

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References

No sources cited because the input does not specify a uniquely identifiable drug record.