Able Company Profile

What is the competitive landscape for ABLE

ABLE has sixty-two approved drugs.

Summary for Able

US Patents:	0
Tradenames:	27
Ingredients:	27
NDAs:	62

Drugs and US Patents for Able

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Able	METRONIDAZOLE	metronidazole	TABLET;ORAL	076519-002	Jun 27, 2003		DISCN	No	No
Able	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	040452-001	Aug 1, 2002		DISCN	No	No
Able	INDOMETHACIN	indomethacin	CAPSULE;ORAL	076666-002	Dec 17, 2003		DISCN	No	No
Able	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040469-001	Oct 25, 2002		DISCN	No	No
Able	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040464-002	Oct 23, 2002		DISCN	No	No
Able	METRONIDAZOLE	metronidazole	TABLET, EXTENDED RELEASE;ORAL	076462-001	Jun 25, 2003		DISCN	No	No

Similar Applicant Names

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

• Able

Last updated: July 1, 2026

Pharmaceutical Competitive Landscape Analysis: ABLE – Market Position, Strengths & Strategic Insights

ABLE is a brand in the US pharmaceutical market, but the requested competitive landscape analysis cannot be produced because the underlying drug identity, active ingredient(s), dosage form, FDA product entry, and corresponding patent estate are not specified. Without those inputs, it is not possible to generate an accurate, litigation- and exclusivity-aware competitor map, Orange Book status, patent expiration timeline, biosimilar or generic risk assessment, or revenue exposure view tied to a specific ABLE product.

What is the FDA status of ABLE (Orange Book listing, exclusivity, and launch date)?

What patents protect ABLE (composition of matter, formulations, methods of use)?

When does ABLE lose exclusivity (Hatch-Waxman and patent expiration timeline)?

Is there paragraph IV generic or biosimilar litigation against ABLE?

How strong is the patent estate for ABLE (claim coverage, jurisdictions, and remaining life)?

Which companies are challenging ABLE (Paragraph IV filers and generic competitors)?

What formulations and strengths of ABLE are covered by patents?

How does ABLE compare with its closest therapeutic competitors (same mechanism and indications)?

What manufacturing and IP barriers affect generic or biosimilar entry for ABLE?

Key Takeaways

FAQs

1. What Orange Book identifiers (application number, NDA/BLA, proprietary name) map to “ABLE”?
2. What is the full patent list for ABLE, including expiring patents and listed NDA exclusivity claims?
3. Which ANDA filers have filed Paragraph IV certifications against ABLE, and what are the litigation outcomes?
4. Which competitors sell substitutable products for the same indication, and how do their exclusivity and patent risks differ?
5. What dosage forms or strengths of ABLE have the highest generic entry risk based on formulation and method-of-use patents?