INVANZ Drug Patent Profile

When do Invanz patents expire, and when can generic versions of Invanz launch?

Invanz is a drug marketed by Msd Sub Merck and is included in one NDA.

The generic ingredient in INVANZ is ertapenem sodium. There are eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ertapenem sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Invanz

A generic version of INVANZ was approved as ertapenem sodium by ACS DOBFAR SPA on April 16^th, 2018.

Summary for INVANZ

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	21
Patent Applications:	5,026
Drug Prices:	Drug price information for INVANZ
What excipients (inactive ingredients) are in INVANZ?	INVANZ excipients list
DailyMed Link:	INVANZ at DailyMed

See drug prices for INVANZ

Recent Clinical Trials for INVANZ

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

Sponsor	Phase
Todd C. Lee MD MPH FIDSA	Phase 2
Iterum Therapeutics, International Limited	Phase 3
Iterum Therapeutics, US Limited	Phase 3

See all INVANZ clinical trials

Pharmacology for INVANZ

Drug Class

Penem Antibacterial

Paragraph IV (Patent) Challenges for INVANZ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INVANZ	Injection	ertapenem sodium	1 g/vial	021337	1	2012-12-21

US Patents and Regulatory Information for INVANZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001	AP	RX	Yes	Yes

Expired US Patents for INVANZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001	5,478,820*PED
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001	7,342,005*PED
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001	5,952,323*PED
Msd Sub Merck	INVANZ	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	021337-001	Nov 21, 2001	5,652,233*PED

International Patents for INVANZ

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

Country	Patent Number	Title	Estimated Expiration
Argentina	006284	UNA COMPOSICION FARMACEUTICA DE CARBAPENEM, UNA FORMA ESTABILIZADA DEL MISMO, COMPOSICIONES FARMACEUTICAS DE ESTE COMPUESTO Y UN METODO PARAESTABILIZAR UN CARBAPENEM
Poland	324746
Czech Republic	9800253
Eurasian Patent Organization	000534	КАРБАПЕНЕМОВЫЙ АНТИБИОТИК, КОМПОЗИЦИЯ И СПОСОБ ПОЛУЧЕНИЯ (CARBAPENEM ANTIBIOTIC, COMPOSITION AND METHOD OF PREPARATION)
Austria	252584
Iceland	4663
Germany	69322007

Supplementary Protection Certificates for INVANZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0579826	SPC/GB02/042	United Kingdom		PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422
0579826	300104	Netherlands		PRODUCT NAME: ERTAPENEM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ERTAPENEMNATRIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020422
0579826	C300104	Netherlands		PRODUCT NAME: ERTAPENEM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ERTAPENEMNATRIUM; NAT. REGISTRATION NO/DATE: EU/1/02/216/001 20020418; FIRST REGISTRATION: EU/1/02/216/001 20020418
0579826	SPC027/2002	Ireland		SPC027/2002: 20040929, EXPIRES: 20170417
0863901	PA2004008	Lithuania		PRODUCT NAME: ERTAPENEMUM ([4R,5S,6S]-3-[(3S,5S)-5-[(3-KARBOKSIFENIL) AMINO]KARBONIL]-3-PIROLIDINIL]TIO]-6-[(1R)-1HIDROKSIETIL]-4-METIL-7-OKSO-1-AZABICIKLO-[3.2.0]HEPT-2-EN-2-KARBOKSIRUGSTIS; REGISTRATION NO/DATE: 03/8043/3 20030328
0579826	02C0041	France		PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
0579826	36/2002	Austria		PRODUCT NAME: ERTAPENEM UND ALLE PHARMAZEUTISCH ANNEHMBAREN SALZE DAVON, INSBESONDERE NATRIUM-ERTAPENEM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418

INVANZ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for INVANZ (Ertapenem Injection)

Overview of INVANZ

INVANZ, the branded formulation of ertapenem, is a carbapenem antibiotic used to treat a wide range of bacterial infections, including complicated intra-abdominal infections, complicated skin and skin structure infections, community-acquired pneumonia, and complicated urinary tract infections. Here’s a detailed look at the market dynamics and financial trajectory of INVANZ.

Global Market Size and Growth

The global ertapenem injection market, which INVANZ dominates, is projected to be significant. As of 2024, the global market size is estimated at USD 25,142.2 million, with a compound annual growth rate (CAGR) of 12.5% from 2024 to 2031[1].

Regional Market Performance

North America

North America is the leading region in the ertapenem injection market, driven by rising antibiotic-resistant infections and increasing healthcare spending. The market size in North America is expected to be USD 10,056.9 million in 2024, growing at a CAGR of 10.7% from 2024 to 2031. The United States, in particular, accounts for a substantial portion, with sales revenue of USD 7,934.88 million in 2024 and a CAGR of 10.5% during the forecast period[1][3].

Europe

In Europe, countries like Germany, Italy, Russia, and Spain also contribute significantly to the market. For instance, Germany's ertapenem injection market is expected to grow at a CAGR of 11.2%, while Italy and Russia are projected to grow at 10.4% and 10%, respectively[1].

Asia-Pacific

The Asia-Pacific region is experiencing rapid growth due to increasing healthcare investments and rising incidences of bacterial infections. This region is anticipated to hold a prominent share in the market during the forecast period, driven by the growing need for effective antibiotics like ertapenem[4].

Market Segments

Branded vs. Generic

INVANZ, the branded version of ertapenem, continues to dominate the market due to its established safety profile and convenience of once-daily dosing. However, the generic version of ertapenem is the fastest-growing segment, enhancing accessibility and affordability for healthcare providers. The introduction of generic versions has significantly boosted the market by allowing a broader range of hospitals and clinics to use effective treatment options against bacterial infections[1].

Application and Type

The global ertapenem market is segmented based on type (purity levels) and application (injection and tablet). The injection segment is anticipated to hold a prominent share, driven by the increasing incidence of infections such as pneumonia, urinary tract infections, and skin infections[4].

Financial Performance

Revenue and Growth

The financial performance of INVANZ is closely tied to the overall ertapenem injection market. Given its dominance, INVANZ drives a significant portion of the revenue in this market. For example, the global ertapenem injection market's revenue of USD 25,142.2 million in 2024 indicates strong financial performance for INVANZ and its generic counterparts[1].

Royalty and Licensing

Companies like Innoviva, which receive royalties from products like INVANZ, have seen substantial financial growth. Innoviva reported net product revenues of $19.1 million in the first quarter of 2024, representing a 66% year-over-year growth, although this specific growth is not solely attributed to INVANZ but indicates a strong royalty income stream from such products[2].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the global ertapenem market. While it caused a slowdown in manufacturing across various industries, the pandemic also highlighted the importance of effective antibiotics in treating secondary bacterial infections. This has led to an increased focus on antibiotic resistance and a subsequent boost in demand for antibiotics like ertapenem[4].

Competitive Landscape

The ertapenem market is competitive, with several major players including Merck & Co., Inc., Pfizer Inc., Sumitomo Dainippon Pharma Co., Ltd., and others. These companies are adopting various strategies such as mergers and acquisitions, collaborations, and new product launches to stay competitive. For instance, Endo International PLC launched an authorized generic version of INVANZ, which has contributed to the market's growth[4].

Key Players and Strategies

• Merck & Co., Inc.: As the original developer of INVANZ, Merck continues to play a significant role in the market.
• Endo International PLC: Through its subsidiary Par Pharmaceutical, Endo has launched an authorized generic version of INVANZ, expanding market access.
• Other Players: Companies like Kopran Ltd., Canagen Pharma Inc., and Taiwan Savior Lifetec Corp. are also contributing to the market through various strategic initiatives[4].

Future Outlook

The future outlook for INVANZ and the broader ertapenem injection market is promising. With increasing healthcare investments, growing awareness of antibiotic resistance, and an aging population, the demand for effective antibiotics is expected to rise. The Asia-Pacific region, in particular, is anticipated to drive significant growth due to its large population and increasing healthcare expenditure[1][4].

Key Takeaways

• Global Market Growth: The global ertapenem injection market is expected to grow at a CAGR of 12.5% from 2024 to 2031.
• Regional Dominance: North America, particularly the United States, dominates the market, but the Asia-Pacific region is growing rapidly.
• Branded vs. Generic: INVANZ dominates the branded segment, while generic versions are the fastest-growing segment.
• Financial Performance: Strong revenue and growth are driven by increasing demand for effective antibiotics.
• Competitive Landscape: The market is competitive with major players adopting various strategies to stay ahead.

FAQs

What is the current global market size for ertapenem injections?

The global ertapenem injection market size is estimated at USD 25,142.2 million in 2024[1].

Which region dominates the ertapenem injection market?

North America, particularly the United States, currently dominates the ertapenem injection market[1][3].

What is the growth rate of the ertapenem injection market in North America?

The ertapenem injection market in North America is expected to grow at a CAGR of 10.7% from 2024 to 2031[1].

How has the COVID-19 pandemic impacted the ertapenem market?

The COVID-19 pandemic has highlighted the importance of effective antibiotics, leading to increased demand despite initial manufacturing slowdowns[4].

Which companies are key players in the ertapenem market?

Key players include Merck & Co., Inc., Pfizer Inc., Sumitomo Dainippon Pharma Co., Ltd., and Endo International PLC, among others[4].

Sources

1. Cognitive Market Research: Ertapenem Injection Market Report 2024 (Global Edition)
2. Innoviva: Innoviva Reports First Quarter 2024 Financial Results; Highlights Recent Company Progress
3. Cognitive Market Research: North America Ertapenem Injection Market Report 2024
4. OMR Global: Ertapenem Market Size, Share, Trends, Industry Report and Forecast 2024-2031