ZAYNICH Drug Patent Profile

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

Zaynich is a drug marketed by Wockhardt Bio Ag and is included in one NDA. There are seven patents protecting this drug.

The generic ingredient in ZAYNICH is cefepime hydrochloride; zidebactam. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the cefepime hydrochloride; zidebactam profile page.

DrugPatentWatch^® Generic Entry Outlook for Zaynich

Zaynich will be eligible for patent challenges on May 29, 2030. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 29, 2036. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ZAYNICH

US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZAYNICH
What excipients (inactive ingredients) are in ZAYNICH?	ZAYNICH excipients list
DailyMed Link:	ZAYNICH at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ZAYNICH

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

NDA:

220787

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for ZAYNICH

ZAYNICH is protected by seven US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wockhardt Bio Ag	ZAYNICH	cefepime hydrochloride; zidebactam	POWDER;INTRAVENOUS	220787-001	May 29, 2026		RX	Yes	Yes
Wockhardt Bio Ag	ZAYNICH	cefepime hydrochloride; zidebactam	POWDER;INTRAVENOUS	220787-001	May 29, 2026		RX	Yes	Yes			Y	Y
Wockhardt Bio Ag	ZAYNICH	cefepime hydrochloride; zidebactam	POWDER;INTRAVENOUS	220787-001	May 29, 2026		RX	Yes	Yes				Y

International Patents for ZAYNICH

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

Country	Patent Number	Title	Estimated Expiration
Australia	2012303691	1,6- diazabicyclo [3,2,1] octan-7-one derivatives and their use in the treatment of bacterial infections
Brazil	112013028813	derivados de 1,6-diazabiciclo[3,2,1]octan-7-ona e seu uso no tratamento de infecções bacterianas
Canada	2833241	DERIVES 1,6-DIAZABICYCLO[3,2,1]OCTANE-7-ONE ET LEUR UTILISATION DANS LE TRAITEMENT D'INFECTIONS BACTERIENNES (1,6- DIAZABICYCLO [3,2,1] OCTAN-7-ONE DERIVATIVES AND THEIR USE IN THE TREATMENT OF BACTERIAL INFECTIONS)

ZAYNICH (Zeinich? ) market dynamics and financial trajectory: exclusivity, competition, and revenue risk map

Last updated: July 5, 2026

No data is available in the provided context to identify the exact active ingredient(s), FDA approval/Orange Book entry, label, dosage forms, approved indications, launch year, or the company tied to “ZAYNICH.” Without these identifiers, a complete and accurate market/financial trajectory and competitive dynamics assessment cannot be produced.

H1 Required content blocked due to missing drug identification

What is ZAYNICH’s active ingredient and FDA status (Orange Book listing)?

No verifiable information is available to map ZAYNICH to an FDA product record, identify exclusivity status, or list Orange Book patents.

What is the Orange Book status of ZAYNICH?

No listing or patent-exclusivity record is available to compile.

Which FDA pathway was used for ZAYNICH?

No approval pathway (NME/BLA/505(b)(1)/505(b)(2)), review class, or exclusivity trigger is available.

When does ZAYNICH lose exclusivity (patent and non-patent exclusivity timelines)?

No patent expiration dates, data exclusivity dates, or orphan/pediatric exclusivity periods can be established from the provided context.

Patent expiration and regulatory exclusivity: what dates matter most?

No expiration or exclusivity dates are available.

Does ZAYNICH face biosimilar or generic entry risk?

No drug class determination is available, so biosimilar vs generic risk cannot be allocated.

What patents protect ZAYNICH (formulations, methods-of-use, and manufacturing)?

No patent estate can be compiled without the correct active ingredient and FDA product match.

How many patents cover ZAYNICH and who holds them?

No assignees or patent families are available.

Which formulation or device patents limit generic substitutes?

No dosage form or formulation information is available.

What patent litigation affects ZAYNICH (Paragraph IV, IPR, injunction outcomes)?

No litigation docket, parties, or settlement terms are available.

Which companies are challenging ZAYNICH?

No challengers can be identified.

What settlement agreements control launch timing?

No settlements can be identified.

What formulations are protected by ZAYNICH patents (strengths, dosage forms, and combinations)?

No dosage strengths or formulation variants are available.

Is ZAYNICH a single-ingredient product or a fixed-dose combination?

No composition information is available.

Are there distinct patents per route of administration?

No route of administration details are available.

How does ZAYNICH compare with competitive therapies (pricing power and substitution likelihood)?

No approved indication and comparator set can be established from the provided context.

What is the competitive landscape for ZAYNICH’s indication?

No competitor products or standard-of-care alternatives are identifiable.

What is the revenue exposure to payer controls and channel mix?

No revenue data or channel mix is available.

What is ZAYNICH’s financial trajectory (revenue, profitability, and market share)?

No financials, launch sales trend, guidance history, or segment reporting tie to ZAYNICH is available.

What were ZAYNICH revenues by year?

No revenue figures are available.

What drives gross margin and OPEX for ZAYNICH?

No cost structure or manufacturing basis is available.

Is ZAYNICH underperforming relative to market expectations?

No expectation baseline is available.

What generic launch scenarios exist for ZAYNICH (timing, labeling, and design-around)?

No patent barriers or regulatory substitutability constraints are available.

Could a “skinny label” generic enter before full exclusivity?

No Orange Book and FDA exclusivity details exist in the provided context.

What are the manufacturing/IP barriers for generic entry?

No formulation/manufacturing patent data is available.

What regulatory milestones shape ZAYNICH’s future demand (post-approval changes and label expansions)?

No label expansion record or regulatory amendments are available.

Are there new strengths, dosage forms, or indications scheduled?

No pipeline expansion details are available.

Does ZAYNICH face REMS or postmarketing commitments?

No REMS/PMCs details are available.

Key Takeaways

• ZAYNICH cannot be mapped to a specific FDA product, patent estate, exclusivity schedule, or commercial track record from the provided context.
• A market dynamics and financial trajectory analysis requires an unambiguous identification of ZAYNICH’s active ingredient, FDA approval record, dosage form, and sponsor.

FAQs

1. What is the FDA approval year and first commercial launch date for ZAYNICH?
2. What patents are listed in the Orange Book for ZAYNICH and when do they expire?
3. Has ZAYNICH faced any Paragraph IV challenges or litigation in federal court?
4. What proportion of ZAYNICH sales are tied to government vs commercial payer channels?
5. What competitive products does ZAYNICH displace, and how does pricing compare?

References

No sources are cited because no verifiable drug identification or FDA/patent/financial data was provided in the prompt.