EMERPHED Drug Patent Profile

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

Emerphed is a drug marketed by Nexus and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has thirteen patent family members in nine countries.

The generic ingredient in EMERPHED is ephedrine sulfate. There are sixty-eight drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ephedrine sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Emerphed

A generic version of EMERPHED was approved as ephedrine sulfate by SANDOZ on August 23^rd, 2017.

Summary for EMERPHED

International Patents:	13
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	446
Drug Prices:	Drug price information for EMERPHED
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMERPHED
What excipients (inactive ingredients) are in EMERPHED?	EMERPHED excipients list
DailyMed Link:	EMERPHED at DailyMed

See drug prices for EMERPHED

Pharmacology for EMERPHED

Drug Class	Norepinephrine Releasing Agent alpha-Adrenergic Agonist beta-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists
Physiological Effect	Increased Norepinephrine Activity

Paragraph IV (Patent) Challenges for EMERPHED

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EMERPHED	Injection	ephedrine sulfate	50 mg/10 mL	213407	1	2021-10-14

US Patents and Regulatory Information for EMERPHED

EMERPHED is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-002	Feb 28, 2023		RX	Yes	Yes	11,571,398
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-001	Apr 17, 2020	AP1	RX	Yes	Yes	11,464,752		Y
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-001	Apr 17, 2020	AP1	RX	Yes	Yes	11,090,278
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-002	Feb 28, 2023		RX	Yes	Yes	11,464,752		Y
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-001	Apr 17, 2020	AP1	RX	Yes	Yes	11,478,436
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-001	Apr 17, 2020	AP1	RX	Yes	Yes	11,241,400
Nexus	EMERPHED	ephedrine sulfate	SOLUTION;INTRAVENOUS	213407-001	Apr 17, 2020	AP1	RX	Yes	Yes	11,571,398

International Patents for EMERPHED

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

Country	Patent Number	Title	Estimated Expiration
Australia	2020276619
Canada	3140043
China	113825500
European Patent Office	3968975
Israel	288044
Japan	2022532657
Japan	2023091072

Supplementary Protection Certificates for EMERPHED

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1110543	08C0004	France		PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
1110543	SPC/GB08/005	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/005 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT DESLORATADINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN COMBINATION WITH PSEUDOEPHEDRINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6322 DATED 21 JULY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 JULY 2022.

EMERPHED Market Dynamics and Financial Trajectory: exclusivity, competitive risk, and revenue outlook

Last updated: July 25, 2026

Executive summary No reliable public record of an FDA-approved pharmaceutical drug marketed as “EMERPHED” is available in the underlying dataset used for this analysis. Without a verifiable drug identity (active ingredient, dosage form, NDA/BLA/ANDA reference, or regulatory listing), market sizing, financial trajectory, exclusivity and patent timing, and competitive scenario analysis cannot be produced with the precision required for licensing, litigation, investment, or R&D decisions.

What is EMERPHED and what active ingredient does it contain?

A complete market and financial trajectory requires the drug’s regulated identity: active ingredient, dosage form, route of administration, and FDA reference product.

What regulatory identifiers must be known for EMERPHED market sizing?

• FDA product type (NDA vs ANDA vs BLA)
• Application number(s)
• Reference listed drug (RLD) name and label strengths
• Orange Book listing entry (active ingredient, dosage form, patent/ exclusivity)

What are the Orange Book status and exclusivity timelines for EMERPHED?

Featured-snippet answer: Orange Book status and exclusivity cannot be determined without the Orange Book RLD match for EMERPHED.

Which exclusivities typically drive launch and cash flow for a brand?

• 5-year new chemical entity (NCE) exclusivity
• 3-year new clinical investigation exclusivity
• 7-year orphan exclusivity (if applicable)
• 6-month pediatric exclusivity and any stacking

What patents protect EMERPHED, and when do they expire?

Patent estate mapping requires exact patent numbers, assignees, and claims tied to the EMERPHED formulation or method of use.

Patent estate components typically tied to revenue retention

• Composition-of-matter patents (active ingredient)
• Formulation patents (excipients, crystal forms, solid state)
• Method-of-use patents (indications, dosing regimens)
• Manufacturing process patents
• Device or combination-product patents (if applicable)

When does EMERPHED lose exclusivity and face generic entry risk?

Generic entry risk is tied to the earliest of:

• patent expirations
• regulatory exclusivity expirations (Orange Book)
• settlement triggers for Paragraph IV litigation

What drives the timing of ANDA approvals for competing generics?

• Paragraph IV filing dates
• FDA approval and labeling carve-outs
• 30-month stay and court timelines
• pediatric and exclusivity extensions

What Paragraph IV challenges and patent litigation affect EMERPHED?

Litigation analysis requires the case docket, asserted patents, and settlement terms, which depend on identifying the correct RLD and its Orange Book patents.

How Paragraph IV strategy impacts financial trajectory

• Pre-launch legal risk premiums on gross-to-net
• Label constraints that sustain price and volume
• Market share erosion timing after 180-day exclusivity starts

How does EMERPHED compare with competing drugs in the same class?

Competitive and substitution dynamics require:

• indication(s) for EMERPHED
• mechanism of action and target
• dosing frequency and safety profile
• payer positioning and contracting history

Market-structure signals used in revenue forecasts

• number of competitors on formulary
• therapeutic alternatives and switching behavior
• net price versus list price erosion rates
• specialty pharmacy versus buy-and-bill mix (if applicable)

What formulations or delivery systems are protected for EMERPHED?

Formulation and delivery-system differentiation can materially change:

• generic “workaround” feasibility
• bioequivalence risk
• REMS or stability-driven market constraints

What to track for generic substitution barriers

• polymorph or hydrate form patents
• particle size distribution and solubility controls
• film coatings or sustained-release matrices
• analytic methods and process controls

What is the biosimilar or bio-exclusivity risk for EMERPHED?

Biosimilar risk requires confirmation that EMERPHED is a biologic (BLA) rather than a small molecule (NDA).

What timelines drive biosimilar entry in the U.S.

• reference product exclusivity (4–12 years depending on designation)
• interchangeability pathways (if applicable)
• patent cluster timing (Biosimilar “patent dance” schedules)

Which companies are challenging EMERPHED, and what is their launch readiness?

This section depends on Paragraph IV filings, ANDA submissions, and FDA approval status.

How challenger behavior translates into financial outcomes

• probability of “at-risk” launch
• ability to secure pharmacy distribution
• expected time-to-market post-approval
• expected volume share based on contracting

What does EMERPHED’s FDA regulatory status indicate about commercialization?

Commercial forecast inputs require FDA status and label maturity:

• initial approval date
• indication expansion timeline
• REMS requirements
• manufacturing capacity readiness

What FDA milestones typically correlate with revenue inflection

• first approval and earliest net sales ramp
• postmarketing commitments completion
• label expansions for new indications
• safety communication events affecting uptake

What does EMERPHED’s financial trajectory look like from launch to present?

A revenue and cash-flow trajectory requires verifiable financials from:

• company quarterly and annual reports
• product-level net sales disclosures
• payer/market access disclosures
• trade sources tied to an identified drug

Financial metrics that typically drive valuation and licensing terms

• net sales by quarter and by indication
• gross-to-net bridge (rebates, discounts)
• cost of goods and gross margin profile
• R&D spend and SG&A allocation
• milestones and royalties under existing licensing deals

Key drivers of near-term and medium-term revenue for EMERPHED

A driver tree requires confirmed:

• active ingredient and label
• competitor set
• exclusivity and patent expiration schedule
• current market access footprint

Standard revenue drivers used in corridor forecasts

• formulary placement and tiering changes
• competitor intensity and price pressure
• unit growth versus price erosion
• manufacturing interruptions and supply stability
• safety events and guideline updates

What generic launch scenarios exist for EMERPHED?

Generic scenarios require:

• patent expiration and exclusivity timeline
• Orange Book patent list
• ANDA filing activity and 180-day exclusivity ownership

Scenario grid used for investment decisions

• earliest possible at-risk launch date
• first label carve-out constraints
• expected time to 25 percent and 50 percent market share penetration
• projected net price decline curve post-entry

How strong is the patent estate for EMERPHED versus common generic/small-molecule workarounds?

This analysis requires the exact claims landscape and expiration dates.

Common estate “strength” indicators

• number of unexpired Orange Book patents at the formulation/composition level
• presence of method-of-use claims covering peak-prescribing indications
• injunction history in comparable RLD estates
• claim breadth and dependency complexity

Geographic coverage: where EMERPHED is most exposed to generic competition

Geographic risk depends on regulatory status in major markets:

• U.S. (FDA/Orange Book)
• EU (EMA and EP/ SPC landscape)
• UK (MHRA and SPC)
• major generics markets (Canada, Australia, Brazil, India)

How to map cross-jurisdiction IP risk

• national phase filing dates
• patent term adjustments and extensions
• supplementary protection certificates (SPCs)
• local approval of generics and follow-on products

Key Takeaways

• EMERPHED cannot be matched to an FDA-approved product identity in the dataset used for this analysis.
• Without a verified active ingredient and regulatory listing (NDA/BLA, Orange Book RLD match), exclusivity timelines, patent expiration dates, Paragraph IV risk, competitor landscape, and financial trajectory cannot be produced to the standard required for business decisions.

FAQs

1. What does “EMERPHED” refer to in FDA drug databases?
2. How can I confirm EMERPHED’s Orange Book RLD entry before modeling generic risk?
3. What exclusivity types most often delay generic entry for U.S. brand drugs?
4. How do Paragraph IV settlements affect net revenue after generic launch?
5. What disclosures in SEC filings typically provide product-level net sales needed for trajectory modeling?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 2026-07-25)

DrugChatter Q&A for EMERPHED

Emerphed ephedrine sulfate injection?