Salerno Pharms Company Profile

What is the competitive landscape for SALERNO PHARMS

SALERNO PHARMS has one approved drug.

There are two US patents protecting SALERNO PHARMS drugs.

There are eight patent family members on SALERNO PHARMS drugs in twelve countries and five supplementary protection certificates in five countries.

Summary for Salerno Pharms

International Patents:	8
US Patents:	2
Tradenames:	1
Ingredients:	1
NDAs:	1

Drugs and US Patents for Salerno Pharms

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salerno Pharms	FLOLIPID	simvastatin	SUSPENSION;ORAL	206679-001	Apr 21, 2016		RX	Yes	No	10,300,041		Y
Salerno Pharms	FLOLIPID	simvastatin	SUSPENSION;ORAL	206679-001	Apr 21, 2016		RX	Yes	No	9,597,289		Y
Salerno Pharms	FLOLIPID	simvastatin	SUSPENSION;ORAL	206679-002	Apr 21, 2016		RX	Yes	Yes	9,597,289		Y
Salerno Pharms	FLOLIPID	simvastatin	SUSPENSION;ORAL	206679-002	Apr 21, 2016		RX	Yes	Yes	10,300,041		Y

International Patents for Salerno Pharms Drugs

Country	Patent Number	Estimated Expiration
Australia	2007245410
Slovenia	2018153
Australia	2007245410
Spain	2385752

Supplementary Protection Certificates for Salerno Pharms Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	05C0040	France		PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0720599	122004000026	Germany		PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 58866.00.00 58866.01.00 58866.02.00 58866.03.00 58870.00.00 58870.01.00 58870.02.00 58870.03.00 58874.00.00 58874.01.00 58874.02.00 58874.03.00 58878.00.00 58878.01.00 58878.02.00 58878.03.00 20040402 FIRST REGISTRATION: DE 58866.00.00 - 58866.03.00 58870.00.00 - 58870.03.00 58874.00.00 - 58874.03.00 58878.00.00 - 58878.03.00 20040402
0720599	SPC/GB05/010	United Kingdom		PRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH SIMVASTATIN; REGISTERED: DE 58874.00.00 20040402; DE 58874.01.00 20040402; DE 58874.02.00 20040402; DE 58874.03.00 20040402; DE 58878.00.00 20040402; DE 58878.01.00 20040402; DE 58878.02.00 20040402; DE 58878.03.00 20040402; DE 58866.00.00 20040402; DE 58866.01.00 20040402; DE 58866.02.00 20040402; DE 58866.03.00 20040402; DE 58870.00.00 20040402; DE 58870.01.00 20040402; DE 58870.02.00 20040402; DE 58870.03.00 20040402; UK PL 19945/0003 20041118; UK PL 19945/0004 20041118; UK PL 19945/0005 20041118; UK PL 19945/0006 20041118; UK PL 19945/0007 20041118; UK PL 19945/0008 20041118; UK PL 19945/0009 200411
0720599	26/2005	Austria		PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON KOMBINIERT MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 1-25673 - 1-25676 20041228; FIRST REGISTRATION: DE 58874.00.00 - 58874.03.00; 58878.00.00 - 20040402

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Salerno Pharms

Last updated: July 21, 2026

Salerno Pharms Competitive Landscape Analysis: Market Position, Patent/IP Strength, and Generic vs. Brand Risk

Salerno Pharms is not identifiable from the provided prompt with enough specificity to map a complete competitive landscape (product portfolio, FDA status, sales/revenue exposure, manufacturing footprint, and a defensible patent estate). Without those hard identifiers, any market-position, exclusivity, Paragraph IV, Orange Book, or litigation conclusions would be non-actionable.

What is the market position of Salerno Pharms in its primary therapeutic areas?

No data sufficient to confirm Salerno Pharms’ active marketed products, therapeutic focus, or geography-specific revenue footprint.

Which products drive Salerno Pharms sales?

No product-level identifiers (NDAs/ANDAs/BLA, NDCs, dosage forms) provided.

How does Salerno Pharms compete versus incumbents and generics in the U.S.?

No confirmed FDA product list or Orange Book linkages provided for Salerno Pharms.

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What patents protect Salerno Pharms’ lead products and how strong is the patent estate?

No drug-to-patent mapping can be produced without the underlying active ingredients, reference listed drug (RLD) names, application numbers, or specific Orange Book entries.

How many patents cover each Salerno Pharms product (composition, formulation, method-of-use, and manufacturing)?

No patent-family identifiers or Orange Book listing datasets provided.

Which assignees and inventors control the IP for Salerno Pharms products?

No assignee or family-level patent numbers provided.

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When does Salerno Pharms lose exclusivity, and what is the generic entry risk timeline?

Exclusivity and patent-expiration timelines cannot be computed without confirmed product/RLD identities, regulatory exclusivity type (3-year/5-year/7-year), and the listed patent expiration dates.

What is the Orange Book status of Salerno Pharms’ portfolio?

No Orange Book entries identified.

When do relevant patents expire for Salerno Pharms’ lead brands?

No patent expiration dates identified.

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Are Paragraph IV challenges filed against Salerno Pharms’ products, and what litigation matters?

No Paragraph IV notice data, case dockets, or settlement/consent decrees provided.

Which ANDA filers are challenging Salerno Pharms’ patents?

No challenger identities provided.

What settlements or consent judgments affect launch dates?

No settlement terms provided.

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Which formulation and delivery patents constrain generics for Salerno Pharms?

No formulation patents or dosage forms identified for any Salerno Pharms product.

What specific dosage forms are protected (tablets, capsules, injectables, sustained-release, transdermal)?

No product dosage forms identified.

Do manufacturing-use patents or process claims block generic supply?

No process/manufacturing patents identified.

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How does Salerno Pharms compare with major competitors in the same drug classes?

No therapeutic class, comparator set, or reference branded/generic products identified.

Who are Salerno Pharms’ top rivals by product overlap and payer coverage?

No competitor list provided.

Which companies have the lowest effective barriers to entry against Salerno Pharms?

No barrier mapping possible without patents, FDA status, and launch calendars.

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What is Salerno Pharms’ FDA regulatory status and product lifecycle stage?

No NDAs/ANDAs/BLA identifiers, approval dates, supplements, or labeling release dates provided.

What FDA pathways are used (505(b)(2), 505(j), 516, 351(a))?

No pathway data provided.

Are there pending approvals or lifecycle changes that change IP risk?

No pending supplement or launch-change data provided.

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What licensing, co-development, or exclusivity deals shape Salerno Pharms’ strategy?

No licensing or commercialization agreements provided.

Who are Salerno Pharms’ licensors and licensees?

No deal data provided.

Do settlements or cross-licenses shorten or extend exclusivity?

No settlement data provided.

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Key Takeaways

• Salerno Pharms’ competitive landscape cannot be produced to a litigation-grade standard without product-level FDA and patent identifiers.
• No defensible conclusions can be stated on exclusivity timelines, Orange Book status, Paragraph IV risk, biosimilar exposure, or formulation/process barriers.
• Any market-positioning or strategic insight would require concrete mapping between Salerno Pharms’ portfolio and specific regulatory applications and patent families.

FAQs

1. How do I verify Salerno Pharms’ Orange Book listings for each marketed product?
2. What metrics show patent-portfolio strength for a generic entry risk model?
3. How do Paragraph IV filings translate into launch-date impact across competing ANDA filers?
4. What formulation patent categories most often block generic switches (strength, release profile, excipients)?
5. How should biosimilar risk be assessed when the RLD is biologic and multiple exclusivities exist?

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References (APA)

No sources cited because no Salerno Pharms identifiers, FDA applications, Orange Book listings, patent numbers, litigation dockets, or docket-linked filings were provided.