Glenmark Speclt Company Profile

What is the competitive landscape for GLENMARK SPECLT

GLENMARK SPECLT has twenty-nine approved drugs.

There are seventeen US patents protecting GLENMARK SPECLT drugs.

Summary for Glenmark Speclt

US Patents:	17
Tradenames:	24
Ingredients:	23
NDAs:	29

Drugs and US Patents for Glenmark Speclt

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	10,758,550
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	10,765,686
Glenmark Speclt	ESOMEPRAZOLE MAGNESIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	209495-001	May 10, 2019		DISCN	No	No
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	12,653,833		Y

International Patents for Glenmark Speclt Drugs

Country	Patent Number	Estimated Expiration
European Patent Office	3468532
China	115444851
Russian Federation	2015128496
Colombia	2025007747

Supplementary Protection Certificates for Glenmark Speclt Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
2435024	2021C/518	Belgium		PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210
1519731	13C0067	France		PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
2435024	202140009	Slovenia		PRODUCT NAME: COMBINATION OF FORMOTEROL (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF), GLYCOPYRROLATE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF) AND BUDESONIDE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF); NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF NATIONAL AUTHORISATION: 20201209; AUTHORITY FOR NATIONAL AUTHORISATION: EU

Similar Applicant Names

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

• Glenmark Generics
• Glenmark Pharms
• Glenmark Pharms Ltd
• Glenmark Speclt

Glenmark Specialty (Glenmark Speclt): Competitive Landscape Analysis, Patent/Regulatory Position, and Generic/Biosimilar Risk

Last updated: June 17, 2026

Glenmark Specialty’s market position and near-term competitive exposure depend on the specific Glenmark “Speclt” portfolio assets tied to the relevant markets (US/Europe/India) and the relevant product-level patent estates. A patent and regulatory competitive landscape for “Glenmark Speclt” cannot be completed from the information provided because no specific drug(s), strength(s), dosage form(s), FDA NDA/BLA identifiers, Orange Book entries, or jurisdictional filings were supplied.

Key issue: which product(s)

• “Glenmark Speclt” can refer to different Glenmark specialty products across territories and time periods. Patent expiration timelines, Paragraph IV eligibility, exclusivity windows, and biosimilar/generic entry risks are product-specific and must be anchored to identifiable regulators listings and patent numbers.

Because no product identity was provided, the analysis below is omitted to avoid generating incomplete or inaccurate patent timelines and litigation/regulatory status.

Key Takeaways

• A complete competitive landscape for Glenmark Specialty requires product-level identification (active ingredient, dosage form, market, and regulator listing such as FDA NDA/BLA and Orange Book patents).
• Patent expiration, exclusivity, and generic entry risk are not computable at the portfolio label level.

FAQs

1. What portfolio-level factors determine generic and biosimilar entry risk for Glenmark Specialty?
2. How do Orange Book patent listings translate into Paragraph IV attack timing windows?
3. What litigation patterns most often affect US specialty product launch dates?
4. How do formulation and method-of-use patents change generic design-around strategies?
5. What commercial KPIs best predict which Glenmark Specialty products face near-term erosion?

References

(No sources cited because no product identifiers, regulator listings, or patent datasets were provided.)