Glenmark Speclt Company Profile

What is the competitive landscape for GLENMARK SPECLT

GLENMARK SPECLT has twenty-nine approved drugs.

There are sixteen US patents protecting GLENMARK SPECLT drugs.

There are ninety-one patent family members on GLENMARK SPECLT drugs in thirty-four countries and one hundred and five supplementary protection certificates in sixteen countries.

Summary for Glenmark Speclt

International Patents:	91
US Patents:	16
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	HAILEY FE 1.5/30	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	209031-001	Jun 5, 2018	AB	RX	No	No
Glenmark Speclt	APREPITANT	aprepitant	CAPSULE;ORAL	207777-001	Oct 12, 2017	AB	RX	No	No
Glenmark Speclt	ROSUVASTATIN CALCIUM	rosuvastatin calcium	TABLET;ORAL	079172-004	Jul 19, 2016	AB	RX	No	No

International Patents for Glenmark Speclt Drugs

Country	Patent Number	Estimated Expiration
Philippines	12015502302
Australia	2019224850
Canada	3023355

Supplementary Protection Certificates for Glenmark Speclt Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0717738	SPC/GB01/025	United Kingdom		PRODUCT NAME: LINEZOLID; REGISTERED: UK PL 00032/0259 20010105; UK PL 00032/0260 20010105; UK PL 00032/0261 20010105; UK PL 00032/0262 20010105
0734381	PA2004002	Lithuania		PRODCUT NAME: 5-[[(2R,3S)-2-[(1R)-1-[3,5-BIS(TRIFLUORMETIL)FENIL]ETOKSI]-3-(4-FLUORFENIL)-4-MORFOLINIL]METIL]-1,2-DIHIDRO-3H-1,2,4-TRIAZOL-3-ONAS (APREPITANTAS); REGISTRATION NO./DATE: EU/1/03/262/001-006/20031111
0137963	97C0042	Belgium		PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121

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 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.)